All product technical documentation for marketed medical devices must be revised by March 2010 to comply with Directive 2007/47/EC – One year left
Quality First International has formed a task force of technical experts to help companies attain or maintain compliance under the new requirements
London, 28 January 2009
With only one year left until all medical devices marketed in Europe need to have their technical documentation converted to the requirements of Directive 2007/47/EC, amending Directive 93/42/EEC, medical device manufacturers will need to give priority to updating their product technical documentation, as well as their Product Design Dossiers for Class III devices.
“It is not simply a case of making a few changes to the Essential Requirements. Literally all product technical documentation for all device classes is affected by the new Directive,” says Haroon Atchia, Chief Executive Officer & Technical Director of Quality First International. “All CE Marking procedures, especially those required by the regulations or invoked by integration in an EN ISO 13485 Quality Management System for instance, would require an update. For the conversion to be possible and to avoid a backlog resulting in potential failure to meet the deadline, manufacturers may wish to request a suitable transition strategy from their Notified Bodies”.
Since a period of transition exists for devices already placed on the market with the CE Marking at 5 September 2007, there may be considerable attraction for manufacturers to assure conversion to the amending Directive in good time. Clinical data will be required for each product, including the possibility of additional clinical investigation or clinical investigation for the first time. Failure to meet the regulatory deadline can ensure e.g. removal from market, compliance enforcement, seizure of product etc.
QFI has formed a task force of technical experts to help companies attain or maintain compliance under the new requirements. Technically – crucially, also legally – it is anticipated that conformity assessment to Directive 2007/47/EC would require scrutiny of:
- continued validity of intended purpose of the medical device concerned (some products not previously requiring clinical data may now require further study to assure validity of intended purpose);
- EC Product Classification;
- adapting and meeting changes to the Essential Requirements;
- elevated requirements for clinical data, especially for Class III devices;
- specific compliance elements for particular medical devices, device subcategory and generic device group, etc.
“It may be sensible, or at least convenient, for manufacturers to coincide the conformity assessment to the new Directive with the audit surveillance cycle exercised by the Notified Body,” Mr Atchia explains. “Due to the potential for very significant changes to a company’s compliance requirements, manufacturers are advised to seek specialist assistance to ensure suitably efficient, pragmatic and cost-effective plans are devised and executed to enable a smooth transition”.
About Quality First International (QFI)
Quality First International Limited (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 and Chinese marketplaces. All submissions made by QFI have fulfilled the compliance requirements first time round, consistently. QFI clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting-edge, minimally invasive and cardiovascular products and implants.
For further information, please contact: