A free 4-page guide to the MHRA's July 2026 clarification and what it means for your DORS registration, fees and UK Responsible Person records.

Quality First International (QFI) has published a free 4-page regulatory circular explaining the difference between placing on the market (POM), putting into service (PIS) and PIS-only status for medical devices in Great Britain.

What changed on 20 July 2026?

On 20 July 2026, the MHRA updated its guidance on registering medical devices to place on the market. The update clarifies how devices should be identified as placed on the GB market, put into service, or put into service only.

The underlying legal concepts in the Medical Devices Regulations 2002 (SI 2002/618, as amended) have not changed. However, an incorrect determination can affect MHRA registration, DORS treatment, fees, post-market surveillance and UK Responsible Person records and controls.

What is the difference between placing on the market and putting into service?

Placing on the market is the first making available of each new or fully refurbished device on the GB market, whether for payment or free of charge, with a view to distribution, use or both. Putting into service is, for most devices, the first making available in Great Britain to the final user, which may be a professional organisation.

Devices for clinical investigation are excluded from the ordinary definition of placing on the market. For active implantable devices, a separate rule applies to making the device available to a practitioner for implantation.

What does PIS-only mean?

PIS-only is an MHRA administrative status, not a third legal event. It applies where a device has been put into service in Great Britain but no earlier qualifying GB placing on the market has taken place for that device.

A genuine example is a device manufactured and used internally, where it was never placed on the GB market first. Devices that have been both placed on the market and put into service must not be designated PIS-only.

The MHRA sets out its approach in its guidance on the registration requirements for medical devices placed on the market and put into service.

Does a missing POM date mean a device is PIS-only?

No. The absence of a recorded placing on the market date does not, on its own, establish PIS-only status. The status must be supported by evidence.

Can an invoice or delivery date prove when a device was placed on the market?

Not on its own. Payment, invoices, transfer of title, customs import dates, delivery, commissioning and first patient use are all useful evidence. None of them is an automatic legal test. Labels such as "loan", "demo", "evaluation" or "refurbished" do not decide the status either.

What about the 11 September 2026 deadline?

Under the MHRA's 2026 implementation arrangements, relevant PIS-only records in DORS (the MHRA's Device Online Registration System) had to be reviewed or updated for the 2026/27 fee recalculation by 11 September 2026. This follows the new annual registration fee introduced by The Medical Devices (Fees Amendment) Regulations 2026 (see the MHRA's fees guidance). Manufacturers who are unsure whether their records are correct should review them now.

How does QFI determine status correctly?

QFI's circular sets out an 8-step determination sequence:

1. Territorial market
2. Regulatory device identity
3. Device state and continuity
4. Complete supply route
5. First qualifying GB making available
6. Final user
7. Putting into service
8. PIS-only, further making available, or identity re-set

Which situations are most difficult to assess?

The circular explains the typical issues in each of these areas:

1. Capital equipment: placing on the market may happen before installation and putting into service may follow commissioning or clinical release
2. Lease, loan and free-of-charge supply: title or payment is not essential to placing on the market
3. Consignment: control and the right to withdraw or use the device may matter more than invoicing
4. Internal manufacture and use: can support genuine PIS-only status where no earlier GB placement occurred
5. Used devices: later resale or relocation is usually a further making available, not a new first POM or PIS
6. Full refurbishment: can re-set the device's regulatory identity and start a new POM and PIS history
7. Software and systems: identify the regulated device and whether its identity continues after a change
8. Export and territories: GB, Northern Ireland, the Crown Dependencies and the Overseas Territories must be distinguished first. If Northern Ireland or the EU is in scope, our practical EUDAMED guide is a good companion read.

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Who must register a device if the manufacturer is outside the UK?

A manufacturer based outside the UK must appoint a UK Responsible Person, who registers its devices with the MHRA on its behalf. Read the MHRA's guidance on regulating medical devices in the UK.

How QFI can help

With 31 years of regulatory, compliance and market surveillance expertise, QFI supports manufacturers with UK, EU, US and international requirements.

For manufacturers outside the UK, QFI can support your route to market and act as your UK Responsible Person.

QFI can also:

1. Determine the POM and PIS status of individual devices and device populations
2. Reconstruct and evidence historic POM and PIS chronology
3. Review PIS-only eligibility and supporting evidence
4. Reconcile DORS registrations and fees
5. Assess complex supply models: capital equipment, consignment, lease and managed-equipment arrangements
6. Assess software, accessories and system identity
7. Review used, repaired, reconditioned and fully refurbished devices
8. Train your team on DORS and GB national requirements
9. Support remediation and MHRA enforcement matters
10. Develop procedures, instructions and checklists, backed by our Quality Management System expertise

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