qualityfirstinternational2910736c63960259ac01534fdca22fb3

Have Your Say Before 19 June: What the MHRA's Draft 2026 Regulations Mean for You

Thu, 11 Jun 2026 13:59:26 GMT

The UK is rewriting the rules for placing medical devices on the market and you have until 19 June 2026 to help shape them. Here is what is changing and how to respond to those changes.

Published by Quality First International - 11 June 2026

The UK is rewriting the rulebook for placing medical devices on the market and for a short window, you can help shape it.

On 8 May 2026 the MHRA published the draft Medical Devices (Amendment) Regulations 2026 . Alongside it, the regulator opened a survey asking manufacturers and others what the changes would mean in practice. That survey closes at 11:59pm on 19 June 2026 .

This is one of the most significant reform of Great Britain's device rules since Brexit. If you design, register or place medical devices or IVDs on the GB market, it will affect you. Below, we explain what is proposed, how it fits the wider reform picture, what it could mean for your business, and how to have your say before the deadline.

Key facts at a glance

Published: 8 May 2026 on the World Trade Organisation notification portal ; opened to stakeholders on 11 May.
Survey deadline: 11:59pm (UK time), 19 June 2026.
Scope: pre-market rules for medical devices and IVDs entering the GB market.
Headline measure: an "international reliance" route using approvals from Australia, Canada and the USA.
Also proposed: mandatory UDI, implant cards, closer alignment with international and EU standards, and a software/AI change pathway.
Expected timing: made around the end of 2026, with the main rules following roughly six months later, and the international reliance route expected around 2028 (subject to Parliament).

What are the draft Medical Devices (Amendment) Regulations 2026?

They are a proposed update to the UK Medical Devices Regulations 2002 , a long-standing rulebook for selling medical devices in Great Britain.

In plain terms, the MHRA wants to modernise how products reach the GB market: faster routes for safe, proven devices, with strong safety checks kept firmly in place. As the MHRA's announcement sets out, the aim is to give patients quicker access to innovative technology while supporting growth in the UK MedTech sector.

This matters to us at Quality First International for a simple reason: we know this legislation inside out. Our Technical Director, Haroon Atchia produced a consolidated version of the UK Medical Devices Regulations 2002 , tracking every amendment made since they were first written. When the 2026 changes land, we will be reading them against that full history and not just from a standing start.

What is the MHRA survey and when is the deadline?

The survey is a stakeholder impact survey . It asks for real-world evidence on the likely costs, benefits, challenges and practical effects of the proposed changes.

The MHRA will use the responses to build its official Impact Assessment and to refine the rules before they become law. In short, this is your genuine chance to influence the final version.

The deadline is 11:59pm (UK time) on 19 June 2026. You can read the proposals and respond through the MHRA stakeholder impact survey on GOV.UK.

What is changing? A closer look at the key proposals

The MHRA has set out a broad package. Here are the changes most likely to affect your work, with our read on what each one means.

1. An international reliance route. Devices already approved by trusted regulators in Australia, Canada and the USA could reach the GB market more quickly, by cutting duplicate assessments. This is the most commercially significant proposal. Important caveat: it is not a free pass. MHRA oversight, registration and post-market duties would still apply, so your GB obligations do not disappear.

2. Closer alignment with international and EU standards. The draft would move GB's essential requirements towards best international practice and bring them closer to the EU's Medical Devices Regulation and IVDR , adapted for UK use. If you already meet EU MDR, you may be a step ahead, though, as we explain below, this alignment is not guaranteed to last.

3. New IVD classification. In vitro diagnostic devices would be classified in line with IMDRF standards which is a risk-based system. For many IVD makers this could change the class of a product and with it the route to market. If you make diagnostics, this is the section to read first.

4. Mandatory UDI. Unique Device Identifiers would become compulsory, so devices can be traced precisely across their whole lifecycle. Expect detailed rules on when a new UDI is needed, for example, after changes to design, intended purpose, software or packaging. Crucially, UK Responsible Persons would carry new duties to submit, verify and maintain UDI data in MHRA systems. If you rely on a UK Responsible Person , make sure they are ready for this step.

5. Implant cards. Organisations that implant devices would have to give patients a card with key information about what was implanted that is improving safety follow-up and transparency.

6. A change pathway for software and AI. The draft is expected to formalise "Predetermined Change Control Plans" (PCCPs), letting manufacturers plan certain software updates in advance, with strong version control, change management and cybersecurity expectations. This sits neatly alongside the EU's separate AI rules. For AI-enabled devices, this is a fast-moving area which our AI technical services team follows closely.

7. Stronger technical documentation retention. Manufacturers would need to keep technical documentation for an appropriate, defined period. This is part of a wider tightening of record-keeping that links to your quality management system .

8. New rules for custom-made devices. Improved traceability and the ability to use electronic prescriptions.

9. Claims must match intended purpose. Manufacturers would have to make sure marketing claims line up with the device's stated intended purpose that is closing the gap between what a device says it does and what it is approved to do.

How does this fit the wider UK reform picture?

The 2026 draft does not stand alone. It is the pre-market piece of a much larger reform programme, and it lands while several other changes are already in motion:

1.Post-market surveillance. Tougher PMS rules for GB came into force on 16 June 2025, so manufacturers are already adapting to stronger monitoring and reporting duties.

2. Recognising CE-marked devices. Earlier in 2026 the MHRA consulted on recognising EU MDR/IVDR-compliant devices in Great Britain on a long-term basis, alongside extended transitional arrangements.

3. The end of the "transition era". Together, these moves signal a shift away from temporary, post-Brexit recognition measures towards a standalone, but internationally aligned GB framework.

The MHRA frames all of this within the Government's Life Sciences Sector Plan , which sets an ambition for the UK to become one of the three fastest countries in Europe for accessing MedTech by 2030.

Will the UK and EU rules align or diverge?

This is the question we are hearing most from clients. The draft moves GB closer to the current EU framework , but the EU is, at the same time, working on its own simplification of the MDR and IVDR. If both sides keep changing, the two regimes could continue to drift apart in the detail.

For manufacturers selling into both markets, that means watching two moving targets at once. It is exactly where cross-market experience earns its keep. QFI supports clients on both sides of the Channel — as a UK Responsible Person and as an EU Authorised Representative . Divergence is something we manage daily and not a surprise. (If the EU market is on your radar, our practical EUDAMED guide is a good companion read.)

When will the changes take effect?

Timings are not yet fixed, but the current expectation is:

The regulations are made around the end of 2026 (subject to review and approval by Parliament).
The main pre-market rules follow roughly six months later — around mid-2027.
The international reliance route is expected around 2028 .

Because draft legislation must be open for international comment for a set period before it is laid before Parliament, the final text may still change. That is precisely why your survey response carries weight now.

Who should respond and why it matters to you

The MHRA wants to hear from the whole sector: manufacturers, UK Responsible Persons, approved bodies, healthcare providers and patients. It is especially keen to hear directly from manufacturers , who will live with these rules day to day.

Responding matters because:

The rules are not final. Evidence you give can change them.
The impact is broad. Classification, technical files, labelling, UDI, claims and software all sit in scope.
Early sight is an advantage. Firms that read the draft now will plan calmly; latecomers will scramble.
It could work in your favour. If you already hold approvals in the USA, Canada or Australia, the reliance route may speed your access, therefore tell the MHRA how.

How to respond to the survey: a practical approach

You do not need to comment on everything. A focused, evidence-based response is more useful than a broad one.

We suggest:

1.Read the draft and the MHRA's guidance questions in full.

2. Map the proposals against your own portfolio note where classification, technical documentation, UDI or claims would change for your specific devices.

3. Gather real numbers likely costs, timescales and resource needs. The MHRA is asking for evidence, not opinions.

4. Be specific about impact explain how a change would help or hinder your route to market.

5. Submit before 11:59pm on 19 June 2026.

How QFI can help

Quality First International has advised medical device manufacturers on European regulatory compliance since 1995. Our founder, Haroon Atchia, brings an MHRA background and serves as Honorary Lecturer at the University of Cambridge and member of the Editorial Advisory Board of the Journal of Medical Device Regulation.

Our clients range from start-ups to multinationals, with deep experience in minimally invasive and cardiovascular products and implants.

For this reform, we can:

Assess the impact of the draft 2026 regulations on your specific products and classifications.
Help you prepare a clear, evidence-based survey response before the deadline.
Get you ready for what's coming :UDI, technical documentation, software change control and stronger post-market surveillance.
Support your route to market as your UK Responsible Person .

Book a free 20-minute call and we will assist you with your next steps.

Get in touch with QFI.

EUDAMED: A Practical Guide for Medical Device Manufacturers

Wed, 27 May 2026 23:38:14 GMT

Understanding the EUDAMED system, meeting the deadlines and getting your data right.

Published by Quality First International — 28 May 2026

The medical device regulatory landscape has shifted

For years, EUDAMED existed in the background. Manufacturers heard about it, watched the delays and treated it as a problem for another day.

That day is here. As of 28 May 2026, four EUDAMED modules are mandatory.

At Quality First International we have spent the past several months helping clients prepare for this exact moment. What we have seen across the industry is that many organisations treated EUDAMED as a distant concern and are now facing immediate compliance obligations with real consequences for EU market access.

Whether your organisation is already registered or still working through the process, this guide sets out what EUDAMED is, what it demands and the practical steps to take from here. It reflects what we advise our own clients, drawn from decades of regulatory experience across the EU, UK and international markets.

What is EUDAMED? The European Database on Medical Devices explained

EUDAMED stands for the European Database on Medical Devices. The European Commission built it to support the EU Medical Devices Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746).

Before EUDAMED, information about medical devices, the companies behind them, the certificates supporting them and the safety data connected to them was scattered across separate national databases in each EU Member State. There was no single, unified picture. EUDAMED changes that. It brings together device registration, company identification, certificate records, clinical investigation data, safety reporting and market surveillance into one interconnected system.

The goal is simple: make it possible for regulators, Notified Bodies and the public to see who is placing what on the market, whether it has been properly assessed and what happens to it after it reaches patients.

What triggered the mandatory deadline?

On 27 November 2025, the European Commission published Commission Decision (EU) 2025/2371 in the Official Journal of the European Union. This formally confirmed that four of the six EUDAMED modules meet the required functional specifications.

Under Regulation (EU) 2024/1860, that publication triggered an automatic six month transition period. Once the six months expire, the obligations connected to those modules apply in full.

The result: from 28 May 2026, four EUDAMED modules are mandatory for all relevant economic operators, Notified Bodies and Competent Authorities.

This is a legal obligation, not a recommendation. If a regulatory requirement falls under one of the four operational modules, it must now be fulfilled through EUDAMED. Previous national registration processes no longer satisfy these requirements.

What are the six EUDAMED modules and which are mandatory?

EUDAMED is built around six modules. Each one addresses a different part of the medical device lifecycle. Together, they create a connected record from the point a company enters the EU market through to ongoing safety monitoring.

We regularly walk clients through these modules in our consultations. Here is what each one does and why it matters.

Module 1: Actor Registration — your gateway to the system

This is where it all begins. Every economic operator that places medical devices or IVDs on the EU market must register as an "actor" and receive a Single Registration Number (SRN).

At QFI, we describe the SRN as the master key. It unlocks every other part of EUDAMED. Without it, a manufacturer cannot register devices, link certificates or interact with the system in any meaningful way.

The registration requirement applies to EU manufacturers, non EU manufacturers, Authorised Representatives, importers and system or procedure pack producers.

There are several practical realities that we consistently raise with clients:

One company, multiple roles. If your organisation operates as both a manufacturer and an importer, for example, you must submit a separate registration for each role. Each one generates its own SRN. Missing a registration means that role is non compliant.

Distributors are excluded. We see this misunderstanding regularly. Distributors do not have an actor role in EUDAMED and will not receive an SRN. This sometimes creates confusion in supply chain teams that expect to see their distribution network reflected in the system.

Non EU manufacturers face an additional step. To register in EUDAMED, a non EU manufacturer must have an active Authorised Representative already in place. The registration request must include a signed mandate summary document. Without this, the application cannot proceed.

Competent Authority approval is required. The SRN is not issued automatically. The relevant national Competent Authority must validate the registration. In our experience, processing times vary significantly between Member States. Leaving this to the last moment creates unnecessary risk.

Two administrators are the minimum. At least two Local Actor Administrators (LAAs) must be assigned to your organisation's EUDAMED account before the UDI/Device module becomes accessible. This is a system requirement that is easy to overlook.

Module 2: UDI/Device Registration — cataloguing your portfolio

Once your SRN is in place, the next step is registering your devices in the UDI/Device module. This is where the detailed product data lives.

Every medical device placed on the EU market must be recorded here using the Unique Device Identification system. The module captures information at two levels:

The Basic UDI DI sits at the "family" level. It groups devices that share the same intended purpose, risk classification and core design characteristics. Think of it as the regulatory anchor for a product family.

The UDI DI sits beneath it, identifying the specific product variant or packaging level. Every packaging tier and variant must be registered separately to ensure full traceability.

The data requirements are defined in Annex VI Part B of the MDR. Manufacturers must provide the device name, risk class, intended purpose, EMDN nomenclature code, conformity assessment route, certificate references, market countries and additional technical attributes. All of this must follow EUDAMED's controlled vocabularies and language specifications.

From our work with clients, we know that the biggest challenge here is not the system itself. It is the data preparation. Many manufacturers discover that their internal product records do not map cleanly to EUDAMED's required fields. Addressing this takes time and cross functional coordination.

Two deadlines govern device registration:

28 May 2026 for any device placed on the EU market from this date onwards must be registered in the UDI/Device module before it reaches the market.

28 November 2026 for legacy devices that were already on the market before 28 May 2026 (and are still being sold) must be registered by this date. This is twelve months from the November 2025 functionality notice.

For legacy devices that have not yet been assigned a UDI DI, EUDAMED generates substitute identifiers (a EUDAMED DI in place of the Basic UDI DI and a EUDAMED ID in place of the UDI DI) to keep the system functional.

Module 3: Notified Bodies and Certificates — connecting the evidence chain

This module records information about notified bodies designated under the MDR and IVDR, together with the certificates they issue, amend, suspend, withdraw or restrict.

Its purpose is to create a transparent and verifiable link between a device on the EU market, the certificate that supports its conformity assessment and the notified body that issued it.

There is an important dependency here that we always flag to clients: the system requires a manufacturer to register a device at the Basic UDI DI level before a Notified Body can upload the related certificate. The manufacturer must act first.

For devices that require Notified Body certification (anything above Class I under the MDR, or Class A under the IVDR), the device enters a "Submitted" state once registered. It remains in that state until the notified body confirms the data. Only then does the status move to "Registered" and appear on the public website.

The deadlines for this module are:

From 28 May 2026 for any newly issued MDR or IVDR certificate must be uploaded to EUDAMED immediately upon issuance.

By 28 May 2027 for notified bodies must complete the upload of all relevant information for existing legacy certificates. This is an eighteen month window from the November 2025 notice.

We advise clients to engage with their notified bodies early on this. Waiting for the Notified Body to act without confirming their readiness can delay the registration of your own devices.

Module 4: Market Surveillance — the regulator's window

This module is primarily a tool for national Competent Authorities. It supports the sharing of inspection findings, non compliance actions, restrictions and corrective measures across EU Member States.

Manufacturers do not interact with this module directly in most cases. However, it draws on the data held in the Actor, UDI/Device and Certificates modules. Incomplete or inaccurate registrations in those modules feed directly into the information regulators use when conducting surveillance.

In practical terms, this means that data quality in the other modules is not just a compliance matter. It shapes how your organisation appears to the regulators responsible for market oversight.

Module 5: Vigilance and Post Market Surveillance — not yet mandatory

This module is still in development. When it goes live, it will replace the current patchwork of national reporting systems with a single interface for serious incident reports, trend analyses and field safety corrective actions.

Under Regulation (EU) 2024/1860, this module will become mandatory six months after the Commission declares it functional. Unlike the first four modules, there will be no period of voluntary use beforehand. When the notice is published, the transition timeline begins immediately.

Until that happens, manufacturers must continue reporting through their existing national processes.

At QFI, we advise clients to begin reviewing their post market surveillance and vigilance procedures now. When this module goes live, the transition will be swift. Companies with well structured PMS processes will adapt far more easily than those still relying on informal or inconsistent reporting workflows.

Module 6: Clinical Investigations and Performance Studies — not yet mandatory

This module will centralise the management of clinical investigations (under the MDR) and performance studies (under the IVDR). It will handle submissions, substantial modifications, lifecycle reporting and summary information.

Like the Vigilance module, it remains in development. It will follow the same activation path: six months after the functionality notice, with no voluntary use period.

For manufacturers planning clinical investigations or performance studies in the near term, we recommend beginning to align internal procedures with anticipated EUDAMED requirements now. The Commission's published functional specifications provide a reasonable basis for preparation. Waiting until the module launches leaves no margin for adjustment.

Who must act and when?

The obligations created by EUDAMED apply across the medical device supply chain. At QFI, we work with manufacturers at every stage of this process, from initial actor registration through to ongoing data governance.

Here is a summary of the key deadlines:

28 May 2026

The four mandatory modules are now in effect. All economic operators must hold valid actor registrations with SRNs. Any device placed on the EU market from today must be registered in the UDI/Device module before market placement. Newly issued certificates must be uploaded by Notified bodies upon issuance.

28 November 2026

Legacy devices (those already on the EU market before 28 May 2026 and still being sold) must be registered in the UDI/Device module.

28 May 2027

Notified Bodies must complete the upload of all relevant legacy certificate information.

Date to be confirmed

The Vigilance/PMS and Clinical Investigations/Performance Studies modules will become mandatory six months after their respective functionality notices. No voluntary use period will apply.

Getting your organisation ready: QFI's recommended approach on how to prepare for EUDAMED

Drawing on our experience advising medical device manufacturers through MDR and IVDR transitions, we recommend a structured five step approach to EUDAMED readiness.

1. Secure your Actor Registration and SRN

This is the non negotiable first step. Every other EUDAMED activity depends on it. If your organisation has not yet registered, treat this as the immediate priority. Allow time for Competent Authority processing and ensure your Authorised Representative arrangements are in place if you are a non EU manufacturer.

2. Audit and prepare your device data

EUDAMED requires structured, detailed product data that aligns with Annex VI Part B of the MDR. Before entering anything into the system, we recommend creating a single controlled data source that maps each EUDAMED field to your internal records.

This is where many manufacturers run into difficulty. Internal product databases were not designed with EUDAMED in mind. Gaps in device naming, classification, intended purpose descriptions and nomenclature codes need to be identified and resolved before data entry begins.

Consistency matters. The information in EUDAMED must match what appears in your technical documentation, your labelling and your instructions for use. Regulators and Notified bodies will cross reference these records. Any discrepancy is visible and creates audit risk.

3. Engage your Notified Body

The Certificates module creates a direct dependency between manufacturer and Notified Body. Your devices must be registered first. Your Notified Body uploads the certificate second. Confirm that your Notified Body understands this workflow and is prepared to act on their end.

4. Align your Quality Management System

EUDAMED is a regulatory obligation that sits across multiple business functions. Treating it as a standalone IT task is one of the most common mistakes we see.

Your QMS should clearly define who is responsible for EUDAMED data entry, review, maintenance and lifecycle updates. Processes for handling device modifications, certificate renewals, market withdrawals and recalls should all reference the corresponding EUDAMED actions.

5. Prepare for what is still to come

The Vigilance and Clinical Investigations modules will arrive without a voluntary familiarisation period. We advise clients to review their post market surveillance processes, vigilance reporting workflows and clinical investigation procedures against the Commission's published specifications now. Early alignment reduces disruption when these modules go live.

What are the most common EUDAMED compliance mistakes?

In our advisory work, certain EUDAMED preparation errors come up repeatedly:

Assuming all six modules are mandatory at the same time. Only four modules are currently live. We have seen manufacturers divert resources into vigilance system redesigns while leaving their core actor and device registrations incomplete. Focus on what is mandatory today.

Treating EUDAMED as a one off exercise. The database requires ongoing data maintenance. Devices are modified. Certificates are renewed or withdrawn. Markets expand. Keeping EUDAMED records current is a continuous obligation, not a task you complete once and set aside.

Starting Competent Authority applications too late. SRN issuance requires Competent Authority validation. Processing times are not standardised across Member States. In some cases, approval takes weeks. Planning for this avoidable delay is essential.

Allowing data to drift between systems. If the device description in EUDAMED does not match the description in your technical file, or if your labelling references a different intended purpose, regulators will notice. Data alignment across EUDAMED, your QMS, your technical documentation and your labelling is a compliance requirement, not a best practice suggestion.

Overlooking legacy device timelines. The 28 November 2026 deadline for registering legacy devices is separate from the 28 May 2026 mandatory date. For manufacturers with large product portfolios, six months is a compressed timeline to audit, prepare and submit all required data.

How can QFI support with EUDAMED registration and compliance?

We work with manufacturers ranging from early stage companies entering the EU market for the first time to established enterprises managing large device portfolios across multiple jurisdictions.

Our EUDAMED support covers:

Actor registration guidance and SRN applications
UDI strategy and device data preparation
Notified Body coordination for certificate linkage
QMS alignment for ongoing EUDAMED data governance
Legacy device portfolio assessment and registration planning
Preparation for the Vigilance and Clinical Investigations modules

Whether you are approaching EUDAMED for the first time or managing the transition of a legacy portfolio to meet the November 2026 deadline, QFI provides the regulatory expertise to keep your EU market access secure.

Contact QFI for expert guidance on EUDAMED compliance.

Email: enquiries@qualityfirstint.com

Quality First International. Client First, Quality Assured.

Hazard and Operability Technique in Medical Device Manufacturing

Fri, 09 Aug 2024 12:36:01 GMT

Exploring the Hazard and Operability Technique in Medical Device Manufacturing: A New Guidance by Haroon Atchia

London, 9 August 2024

Haroon Atchia, CEO of London-based medical device consultancy Quality First International, is proud to announce the release of his new guidance on the application of the Hazard and Operability (HAZOP) technique within the medical device industry. This comprehensive guide aims to fill the existing knowledge gap in safety and reliability engineering for medical devices by providing in-depth analysis, practical insights, and grounded-theory research.

The guidance, entitled “Hazard and Operability Study for Medical Device Manufacturing: Concepts and Application”, was originally conceived as part of Quality First International’s continuing professional development programme, and is designed for technical specialists, safety assessors, inspectors, and researchers involved in medical device safety and reliability engineering. It meticulously explores the HAZOP technique, a critical tool for identifying and managing operational hazards in industrial processes.

Haroon Atchia leverages his extensive experience in inspecting, implementing, and optimising medical device industrial processes, including biomaterials, non-active and active surgical implants, clean room operations, and industrial sterilisation, to present a robust framework for HAZOP in medical device manufacturing.

Key Features of the Book:

1. Comprehensive Introduction to HAZOP: The book begins with an explanation of the HAZOP study procedure, detailing the analysis phases and their relevance to the medical device lifecycle. It also includes historical context and practical examples through detailed worksheets.

2. Development and Application: The evolution of HAZOP technique is thoroughly examined, with Chapter 2 highlighting significant industrial accidents that underscore the importance of rigorous hazard analysis in the medical device industry.

3. Standards and Oversight: Chapter 3 analyses an existing HAZOP standard, discussing critical aspects such as safety oversight, post-study modifications, and the integration of HAZOP with medical device risk management systems and technical reports.

Author's Vision:

"My intention with this book is to provide a clear, contextual understanding of the HAZOP technique and to promote its technical application, particularly in the medical device industry where operational safety is paramount," said Haroon Atchia. "This book serves as a critical resource for professionals dedicated to ensuring the highest standards of safety and reliability in medical device manufacturing."

About the Author:

Haroon Atchia is the CEO of Quality First International, a leading medical device consultancy based in London. With decades of experience in the field, Atchia has established himself as an expert in medical device safety and reliability engineering. His work focuses on optimising industrial processes to enhance safety and compliance in medical device manufacturing.

Availability:

This 74-page document is available from QFI upon request, please contact enquiries@qualityfirstint.com. Price: 89.00 GBP . A discounted price ( 15% OFF ) is offered to QFI clients.

About Quality First International (QFI)

QFI is a London-based medical device consulting company specialising in solving its clients’ regulatory, technical and compliance challenges to enable medical devices to enter the global marketplace. QFI provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, US, Japanese, Australian, Canadian, Mexican and Chinese marketplaces. QFI’s clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting edge, minimally invasive and cardiovascular products and implants. QFI also specialises in various remediation and business excellence initiatives including solutions to regulatory enforcement, corporate integrity arrangements and expert witness services.

For further information please contact:

Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com

UK Medical Devices Regulations 2002

Fri, 02 Aug 2024 09:21:06 GMT

Consolidation of amendments to UK Medical Devices Regulations 2002 published by Quality First International

This sector-specific compilation of changes made to the UK regulations on medical devices creates a clear and thorough consolidated version of the Medical Devices Regulations 2002

London, 02 August 2024

London-based medical device regulatory consultancy Quality First International has published a unique consolidated version of the UK Medical Devices Regulations 2002, to present clearly all amendments made to the legislation to date, excluding changes applicable only in Northern Ireland.

This document is suitable for manufacturers and regulatory experts in the medical device field who wish to understand the evolution of device regulation in the UK since publication of the original Regulations in 2002, up to and including the Medical Devices (Amendment) (Great Britain) Regulations 2023.

The 437-page document is available from QFI upon request, please contact enquiries@qualityfirstint.com .

Price: 450 GBP – a 15% discount is offered to QFI clients.

About Quality First International (QFI)

For further information please contact:

Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com .

Medical device standard QFIS 002:2022 on Medical Apps published by Quality First International

Wed, 29 Nov 2023 14:58:01 GMT

This sector-specific standard has been designed to help manufacturers, developers and technical assessors design, develop and evaluate medical device apps

London, 29 November 2023

London-based medical device regulatory consultancy Quality First International has published Medical Device Standard QFIS 002:2022 Medical device apps - Technical specification - design, development and evaluation. This standard is intended for use as a general technical guide for medical device apps with the aim of ensuring applicable requirements are met by the medical app technology with respect to medical device function, safety and performance.

This standard is suitable for apps designed to be used by professions allied to medicine (e.g. biomedical engineering, chiropody, dietetics, medical physics, occupational therapy, orthoptics, orthotics, physiotherapy, prosthetics, psychology, radiography and speech therapy), in various practices (e.g. electroencephalography, electrocardiography, hearing aids and hearables, audiometry, surgical appliances, ultrasonics, nuclear medicine, industrial therapy and dental ancillary support) and, as necessary, by lay persons.

“This sector-specific standard on medical device apps was motivated by recognition of a void in published coherent technical criteria for medical device apps, presently manifesting in haphazard app design, utility and relevance when assigned a medical or allied use”, says Haroon Atchia, CEO and Technical Director of QFI. “This standard therefore specifies requirements for intended performance, design, design evaluation, manufacture and information supplied by the manufacturer, and tests to demonstrate compliance with applicable regulations.”

The standard is available from QFI upon request, please contact enquiries@qualityfirstint.com . Price: 69.00 GBP.

About Quality First International (QFI)

For further information please contact:

Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com , Website: https://qualityfirstint.com .

New WEBINAR presented by Haroon Atchia is available

Thu, 16 Nov 2023 10:16:54 GMT

For medical device manufacturers who want to understand the requirements of the UK’s new MHRA MORE platform for submissions of device related incidents: New WEBINAR presented by Haroon Atchia is available

London, 16 November 2023

The London-based medical device consultancy Quality First International encourages all medical device manufacturers who want to understand the requirements of the UK’s new MORE platform for submissions of device related incidents to participate in their new webinar:

This webinar offers practical insight into the UK MHRA’s Manufacturer’s On-line Reporting Environment (MORE) platform . It will provide in-depth guidance on how to answer certain elements, covering all forms of incident and other reports which must be notified by manufacturers to the MHRA in the event of an alleged adverse incident involving a medical device. Special notification, for example originating at market surveillance, will also be covered.

Dedicated e-learning modules are presented on manufacturer’s incident reports, market interventions by manufacturers and other topics.

The course is intended for professionals involved in and/or performing adverse incident notification to the MHRA via the MORE platform, such as: Field assurance analysts, Complaint handling personnel, Market surveillance specialists, Enforcement officers, Compliance specialists, Responsible persons, Technical specialists, Regulatory affairs managers.

About Haroon Atchia (presenter of the webinar)

Founder of Quality First International Limited and Adveniunt Medical International Limited, formerly Senior Professional Technical and Scientific Officer at the Medical Devices Agency, UK Department of Health (UK MHRA), specialising in cardiovascular and implantable devices. Member of the Editorial Advisory Board for the Journal of Medical Device Regulation and formerly RAJ (Devices); Expert Witness, lecturer in medical device regulations at University of Cambridge (honorary).

WEBINAR DETAILS:

Date: 6 December 2023

Duration: 13:00 – 17:00 (GMT)

Further information: https://www.qualityfirstint.com/online-webinar

New medical device standard QFIS 003:2022 on an environmental (waste) management system specification just published by Quality First International

Thu, 02 Nov 2023 16:09:02 GMT

This sector-specific standard helps manufacturers understand and ensure sustainable environmental realisation by considering recognised system boundaries, total medical device life-cycle, and environmental risk-thinking through a dedicated, stochastic management system.

London, 1 August 2022

London-based medical device regulatory consultancy Quality First International has published medical device standard QFIS 003:2022 Medical device environmental (waste) management system specification . It is intended for use as a sector-specific management system and to be used in conjunction with relevant trusted standards and good practices.

The standard is applicable to all types of medical devices, support services, externally-provided raw materials, intermediate products and components, constituents, processes and utilities applied to produce, supply, sustain and ultimately dispose of medical devices.

“Sustainability may not be achieved without both full characterisation of a medical device to its environmental fundamentals and its imprint throughout its complete life-cycle, says Haroon Atchia, CEO and Technical Director of QFI. This is crucial in all environmental compartments relevant to a medical device, defining its planetary or system boundaries and safe operating space, intertwined with its basic environmental performance and impact.

Standard QFIS 003:2022 is the first and only standard on this specific subject matter to date. Atchia further explains that “only QFI can assist medical device manufacturers with the know-how and practical resources to implement concepts and radical solutions described by our standard. Also, only QFI’s environmental technical specialist team can conduct comprehensive assessments to the standard. We offer these services as part of our business programme to our members but can also do so on an individual project basis.”

The standard is available from QFI upon request, please contact enquiries@qualityfirstint.com . Price: 175.00 GBP. The price for QFI Medical Device Environmental Management Programme members is 139.00 GBP.

About Quality First International (QFI)

For further information please contact:

Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com , Website: https://qualityfirstint.com .

THE UK GOVERNMENT ANNOUNCES AN INDEFINITE EXTENSION TO THE RECOGNITION OF CE MARKING FOR CERTAIN BUSINESS SECTORS

Fri, 04 Aug 2023 16:00:19 GMT

Medical device and IVD companies are not affected by this extension

London, 3 August 2023

The Department for Business and Trade (DBT) has announced its intention to indefinitely extend the recognition of CE marking for certain industry sectors. This decision means that UKCA marking will no longer be mandatory from the end of December 2024 for businesses included in the 18 regulations that fall under the Department for Business and Trade (DBT).

The government states this is part of a “wider package of smarter regulations designed to ease business burdens and help grow the economy by cutting barriers and red tape. Following extensive engagement with industry, British firms will be able to continue the use of CE marking alongside UKCA”.

It is important to note, however, that the extension does not apply to medical devices or in vitro diagnostics (IVDs). The list of business sectors affected by the extension can be found in the official announcement:

https://www.gov.uk/government/news/uk-government-announces-extension-of-ce-mark-recognition-for-businesses

It is also important to understand that even though certain products may continue to use the CE mark, they must still comply with UK regulations.

Quality First International can assist manufacturers in becoming compliant with the UK regulations. Any enquiries or doubts about these latest developments and their possible consequences may be addressed to: enquiries@qualityfirstint.com .

About Quality First International (QFI)

For further information please contact:

Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com , Website: qualityfirstint.com .

‘THE MEDICAL DEVICES (AMENDMENT) (GREAT BRITAIN) REGULATIONS 2023’ HAVE BEEN PUBLISHED – NEW TRANSITION DEADLINES AND RULES FOR MEDICAL DEVICES

Thu, 22 Jun 2023 21:42:06 GMT

The UK government has published Statutory Instrument No. 627 to amend the deadlines in the Medical Devices Regulations 2002 with effect from 30 June 2023.

London, 21 June 2023

The Medical Devices Regulations 2002 currently specify that the acceptance of CE marked medical devices on the Great Britain market will end on 30 June 2023.

However, on 9 June 2023, the UK government put in place legislation to extend the acceptance of certain CE marked medical devices on the Great Britain market in response to similar changes made in the European Union.

The new arrangements provide that certain CE marked medical devices may continue to be placed on the Great Britain market to the timelines that are applicable to their device class, with an end date of 30 June 2030.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a useful infographic with all applicable timelines for both medical devices and in vitro diagnostics:

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1164062/Infographic_-_Devices_transition_timeline.pdf

Quality First International can assist medical device manufacturers in becoming compliant with the UK regulations. Any enquiries or doubts about these latest developments and their possible consequences may be addressed to: enquiries@qualityfirstint.com .

About Quality First International (QFI)

For further information please contact:

Tel: +44 (0)208 221 2361; Email: enquiries@qualityfirstint.com

AMENDMENT OF THE EUROPEAN MEDICAL DEVICE REGULATION (MDR) ENTERS IN FORCE – NEW TRANSITION DEADLINES AND RULES FOR LEGACY DEVICES AND CUSTOM-MADE DEVICES

Thu, 23 Mar 2023 21:25:58 GMT

London, 21 March 2023

The European Commission has published an amendment to the Medical Device Regulation (MDR) in the Official Journal. One of the amendment’s main features is the extension of the MDR transition periods until 31 December 2027 or 31 December 2028, depending on the device class.

Regulation (EU) 2023/607 of 15 March 2023, amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices, came into force on 20 March 2023. The Regulation introduces an extension of the transition periods provided for in the MDR as long as certain conditions are fulfilled.

It also deletes, in both the MDR and the IVDR, the "sell-off" date, which is the end date after which devices that have already been placed on the market, and remain available for purchase, should be withdrawn.

The Regulation also introduces a new transition period until 26 May 2026 for manufacturers of Class III custom-made implantable devices to obtain certification of their Quality Management System by a Notified Body, as long as certain criteria are met.

“For manufacturers and Authorised Representatives with legacy devices that are eligible under Article 120(2) of the MDR, as amended, their certificates will either have been extended or reactivated automatically on 20 March 2023” explains Haroon Atchia, QFI’s CEO and Technical Director. “However, at this time, there is no mechanism to demonstrate that an expired certificate is still valid, so the Commission will need to provide formal direction and/or guidance on this issue in due course.”

The official press release from the European Commission can be found here:

https://health.ec.europa.eu/medical-devices-sector/new-regulations_en#extension-of-the-transition-periods-provided-for-in-the-regulations

Quality First International assists medical device manufacturers in becoming compliant with the MDR requirements. Any enquiries or doubts about the new Regulation and its possible consequences may be addressed to : enquiries@qualityfirstint.com .

About Quality First International (QFI)

QFI is a London-based medical devices consulting company specialising in solving its clients’ regulatory, technical and compliance challenges to enable medical devices to enter the global marketplace. QFI provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, US, Japanese, Australian, Canadian, Mexican and Chinese marketplaces. All submissions made by QFI have fulfilled the compliance requirements first time round, consistently. QFI’s clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting edge, minimally invasive and cardiovascular products and implants. QFI also specialises in various remediation and business excellence initiatives including solutions to regulatory enforcement, corporate integrity arrangements and expert witness services.

For further information please contact:

Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com , Website: www.qualityfirstint.com .

NEW BOOK RELEASE: “INTRODUCTION TO FUNDAMENTAL AND APPLIED QUALITY SYSTEM FOR MEDICAL DEVICES” JUST PUBLISHED BY QUALITY FIRST INTERNATIONAL

Thu, 26 Jan 2023 14:31:36 GMT

London, 21 December 2022

London-based medical device regulatory consultancy Quality First International has published a new book entitled Introduction to fundamental and applied quality system for medical devices . This book aims to identify the fundamentals of a quality system and provide a science-based construct that will hopefully produce a greater understanding and application of quality system standards.

“Despite numerous publications about quality, quality systems and quality management systems, the respective meanings of these terms are less clear than one might perhaps initially think.”, says Haroon Atchia, author of the book and CEO and Technical Director of QFI. “Even the meaning of system promulgated by ISO is unclear and certainly incomplete. There is no legal definition of quality in the context of a consumer product, including a medical device, contrary to popular myth and extensive use of the word throughout medical device regulations and related texts. Contemporary medical device manufacture and service organisations therefore routinely misinterpret quality as a documented management system, somehow losing sight of true definitions.”

The ubiquity and importance of the use of quality systems and quality management system standards obligates the need for an improved definition of quality as a metric along with a clarification of why each quality system element is an essential or characteristic component of a quality system.

The book is available from QFI upon request, please contact enquiries@qualityfirstint.com . Price: 130.00 GBP .

About Quality First International (QFI)

For further information please contact:

Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com , Website: https://qualityfirstint.com .

NEW ARTICLE: ONE YEAR LEFT TO COMPLY WITH UK MEDICAL DEVICES REGULATIONS

Fri, 13 May 2022 10:40:41 GMT

London-based medical device regulatory consultancy Quality First International (QFI) reminds medical device manufacturers of the approaching end of the grace period for transitioning from compliance under the European Directives and Regulations for medical devices and IVDs

London, 11 May 2022

With the end of the transition period set for 30 June 2023, QFI encourages all manufacturers to apply to UK Approved Bodies as soon as possible to avoid discontinuation or failure to place products on the Great Britain market.

The Enforcement Agency (MHRA) will no longer accept medical device compliance under Council Directives 93/42/EEC, 90/385/EEC and 98/79/EC, nor Regulations (EU) 2017/745 / 2017/746 after 30 June 2023. Further, all manufacturers intending to place medical devices on the UK market must comply with the Medical Devices Regulations 2002 No. 618 (as amended) and apply a UKCA mark to their products.

“The new requirements apply to devices of all classes. We anticipate long conformity assessment processes with UK Approved Bodies”, says Haroon Atchia, CEO and Technical Director at QFI. “Furthermore, the UK MHRA will only accept registration of devices from manufacturers where the manufacturer is based in the UK. If the manufacturer is based outside the UK, he must appoint a UK Responsible Person.”

About Quality First International (QFI)

QFI is a London-based medical device consulting company specialising in solving its clients’ regulatory, technical and compliance challenges to enable medical devices to enter the global marketplace. The company also acts as a UK Responsible Person for manufacturers located outside of the UK. QFI provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, US, Japanese, Australian, Canadian, Mexican and Chinese marketplaces. QFI’s clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting edge, minimally invasive and cardiovascular products and implants. QFI also specialises in various remediation and business excellence initiatives including solutions to regulatory enforcement, corporate integrity arrangements and expert witness services.

For further information please contact:

Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com , Website: https://qualityfirstint.com .

LEADERSHIP THROUGH ECO-FRIENDLY MEDICAL DEVICE MANUFACTURING AND WASTE MANAGEMENT: NEW REGULATORY SERVICE AVAILABLE FROM QFI

Wed, 09 Feb 2022 08:01:44 GMT

The London-based medical device regulatory consultancy Quality First International (QFI) has launched a new programme intended to assist medical device manufacturers in the development of environment-friendly, eco-designed and green medical devices.

“We think it is high time that sustainability and eco-friendliness become topics of discussion in the industry”, says QFI’s CEO and Technical Director Haroon Atchia. “State-of-the-art technology and a value-oriented business culture should go hand in hand nowadays. Our programme can assist value-driven medical device manufacturers to achieve environment-friendly medical devices and to gain leadership through continual improvement of business processes towards environmental sustainability. Our ideas and initiative are fundamental, visionary and innovative, not simply management system-based. Our goal is a certified environment-friendly medical device sector.”

About QFI’s Environmental Waste Management Programme

This new QFI programme unites global and sectoral legislation, initiatives, policies and standards in a seamless, integrated programme to assist manufacturers and other economic operators who design, manufacture, distribute and maintain medical devices in fulfilling environmental targets. QFI is adept in transforming environmental factors into effective, documented systems equipped to ensure clients produce optimally environment-friendly devices and services. With competence in requisite regulatory and technical areas, complemented by scientific professionals in medical device technology, QFI conducts environmental regulatory and management system impact assessments, formulates environmental risk policies, assesses risk thereof, and guides companies seeking improvements in environmental compliance.

About Quality First International (QFI)

For further information please contact:

Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com , Website: https://qualityfirstint.com .

NEW MEDICAL DEVICE STANDARD QFIS 001:2021 ON SAFETY-RELATED FUNCTIONS AND ACTIVITIES

Wed, 09 Feb 2022 07:57:13 GMT

The sector-specific standard was developed to help manufacturers improve the function of medical devices and medical device systems with respect to safety and in accordance with well-established international norms.

London, 29 April 2021

London-based medical device regulatory consultancy Quality First International has published Medical Device Standard QFIS 001:2021 Medical devices – Functional safety – Product development at system level to help manufacturers achieve safer functionality of medical devices and medical device systems.

This standard is suitable for all device types and classifications with the pursuant aim of ensuring a high level of safety and protection in accordance with Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC, Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) and the UK Medical Devices Regulations 2020, SI No. 1478, as relevant. It is intended for use as a general guide in conjunction with relevant trusted standards and good practices.

“Safety is a fundamental qualitative and quantitative element in medical device development; however, this remains intangible for the industry in the absence of precise legislation or official standards defining functional safety requirements”, says Haroon Atchia, CEO and co-founder of QFI. “The activities described and recommended in the standard are intended to achieve improved safety of medical devices and are consistent with well-established international norms, so they should not present any additional burden to an organisation.”

The standard is available from QFI upon request, please contact enquiries@qualityfirstint.com . Price: 69.00 GBP.

About Quality First International (QFI)

For further information please contact:

Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com , Website: https://qualityfirstint.com .

NEW GUIDANCE: UNDERSTAND HOW TO APPLY GENERAL PERSONAL DATA PROTECTION TO MEDICAL DEVICES TO AVOID NON-COMPLIANCE AND FINES

Wed, 09 Feb 2022 07:53:20 GMT

Quality First International has published a guidance book to raise awareness and preparedness of medical device manufacturers with regard to Regulation (EU) 2016/679, encompassing additional elements of the UK Data Protection Act 2018. This sector-specific guidance has been developed to help manufacturers understand and apply personal data protection obligations in the medical devices’ area.

London, 07 June 2021

London-based medical device regulatory consultancy Quality First International (QFI) has published a Medical Device Guidance Book: Guidance on application of Regulation (EU) 2016/679 on data protection to medical devices in the European Union and United Kingdom – Understanding and practice to help manufacturers achieve compliance with the pertinent regulations in the European Union and the United Kingdom.

“The guidance is motivated by recognition that the medical device sector is generally oblivious or cavalier about personal data protection and therefore might be ill-equipped to comply; or worse, exposed to enforcement that could otherwise be avoided easily ”, says Haroon Atchia, CEO and co-founder of QFI. “Fines can be huge for non-compliance with the regulations and this guidance can be used to apply the regulations to improve understanding and practice in the area of general personal data protection.”

The guidance book is available from QFI upon request, please contact enquiries@qualityfirstint.com . 178 pages, PDF, Price: 249 GBP .

About Quality First International (QFI)

For further information please contact:

Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com , Website: https://qualityfirstint.com .

NEW ARTICLE: THE DESIGN PRINCIPLES OF ELECTRICAL SURGICAL INSTRUMENTS

Mon, 15 Nov 2021 10:42:41 GMT

Quality First International has published an article that examines the difficulties in analysing antecedent medical device technology used in modern medicine against new or evolving regulations.

London, 07 June 2021

London-based medical device regulatory consultancy Quality First International (QFI) has published an article: Electrical surgical instrument design principles to help manufacturers understand the importance of clear and categorical assessment of design principles in electrical surgical instruments by highlighting the general deficiencies of, and problems arising from, poor design considerations. The article then identifies factors to consider in the development of the optimum design for these instruments.

“Electrical surgical instruments were invented decades ago. Design principles were never elaborated, and very little thematic or phenomenological research is published on this subject”, says author Haroon Atchia, CEO and co-founder of QFI. “The article elaborates relevant medical device regulatory conformity assessment issues a specialist encounters when evaluating antecedent products, with a particular focus on electrical surgical instruments”.

The article is available from the QFI website for free download. 4 pages, PDF.

About Quality First International (QFI)

For further information please contact:

Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com , Website: https://qualityfirstint.com .

qualityfirstinternational2910736c63960259ac01534fdca22fb3

Have Your Say Before 19 June: What the MHRA's Draft 2026 Regulations Mean for You

The UK is rewriting the rules for placing medical devices on the market and you have until 19 June 2026 to help shape them. Here is what is changing and how to respond to those changes.

Key facts at a glance ﻿

What are the draft Medical Devices (Amendment) Regulations 2026?

What is the MHRA survey and when is the deadline?

What is changing? A closer look at the key proposals

How does this fit the wider UK reform picture? ﻿

Will the UK and EU rules align or diverge?

When will the changes take effect?

Who should respond and why it matters to you

How to respond to the survey: a practical approach

How QFI can help

EUDAMED: A Practical Guide for Medical Device Manufacturers

Understanding the EUDAMED system, meeting the deadlines and getting your data right.

The medical device regulatory landscape has shifted

What is EUDAMED? The European Database on Medical Devices explained

What triggered the mandatory deadline?

What are the six EUDAMED modules and which are mandatory?

Module 1: Actor Registration — your gateway to the system

Module 2: UDI/Device Registration — cataloguing your portfolio

Module 3: Notified Bodies and Certificates — connecting the evidence chain

Module 4: Market Surveillance — the regulator's window

Module 5: Vigilance and Post Market Surveillance — not yet mandatory

Module 6: Clinical Investigations and Performance Studies — not yet mandatory

Who must act and when?

Getting your organisation ready: QFI's recommended approach on how to prepare for EUDAMED

1. Secure your Actor Registration and SRN

2. Audit and prepare your device data

3. Engage your Notified Body

4. Align your Quality Management System

5. Prepare for what is still to come

What are the most common EUDAMED compliance mistakes?

How can QFI support with EUDAMED registration and compliance?

Quality First International. Client First, Quality Assured.

Hazard and Operability Technique in Medical Device Manufacturing

Exploring the Hazard and Operability Technique in Medical Device Manufacturing: A New Guidance by Haroon Atchia

UK Medical Devices Regulations 2002

Consolidation of amendments to UK Medical Devices Regulations 2002 published by Quality First International

Medical device standard QFIS 002:2022 on Medical Apps published by Quality First International

This sector-specific standard has been designed to help manufacturers, developers and technical assessors design, develop and evaluate medical device apps

New WEBINAR presented by Haroon Atchia is available

New medical device standard QFIS 003:2022 on an environmental (waste) management system specification just published by Quality First International

THE UK GOVERNMENT ANNOUNCES AN INDEFINITE EXTENSION TO THE RECOGNITION OF CE MARKING FOR CERTAIN BUSINESS SECTORS

Medical device and IVD companies are not affected by this extension

‘THE MEDICAL DEVICES (AMENDMENT) (GREAT BRITAIN) REGULATIONS 2023’ HAVE BEEN PUBLISHED – NEW TRANSITION DEADLINES AND RULES FOR MEDICAL DEVICES

The UK government has published Statutory Instrument No. 627 to amend the deadlines in the Medical Devices Regulations 2002 with effect from 30 June 2023.

AMENDMENT OF THE EUROPEAN MEDICAL DEVICE REGULATION (MDR) ENTERS IN FORCE – NEW TRANSITION DEADLINES AND RULES FOR LEGACY DEVICES AND CUSTOM-MADE DEVICES

NEW BOOK RELEASE: “INTRODUCTION TO FUNDAMENTAL AND APPLIED QUALITY SYSTEM FOR MEDICAL DEVICES” JUST PUBLISHED BY QUALITY FIRST INTERNATIONAL

NEW ARTICLE: ONE YEAR LEFT TO COMPLY WITH UK MEDICAL DEVICES REGULATIONS

LEADERSHIP THROUGH ECO-FRIENDLY MEDICAL DEVICE MANUFACTURING AND WASTE MANAGEMENT: NEW REGULATORY SERVICE AVAILABLE FROM QFI

NEW MEDICAL DEVICE STANDARD QFIS 001:2021 ON SAFETY-RELATED FUNCTIONS AND ACTIVITIES

NEW GUIDANCE: UNDERSTAND HOW TO APPLY GENERAL PERSONAL DATA PROTECTION TO MEDICAL DEVICES TO AVOID NON-COMPLIANCE AND FINES

NEW ARTICLE: THE DESIGN PRINCIPLES OF ELECTRICAL SURGICAL INSTRUMENTS

Key facts at a glance

How does this fit the wider UK reform picture?