Achieving full compliance with the EU’s medical devices reform package continues to present problems. The tougher requirements of the new regulations and severe constraints on notified body capacity are slowing down effective transition, especially for the large numbers of existing products that were approved under the previous system.
As it became apparent that recertification of all existing devices would not be achieved in time for the deadline of May 2024, concerns around product unavailability were impossible to ignore. EU Commission data showed that by October 2022, notified bodies had received some 8,120 applications from manufacturers for certification under the MDR and had issued 1,990 certificates in accordance with the MDR. However, this was -
“in stark contrast to 21,376 valid certificates issued under Council Directive 90/385/EEC on active implantable medical devices (AIMDD) and Council Directive 93/42/EEC on medical devices (MDD) that will expire between January 2023 and 26 May 2024.”
Extension of the transition periods for existing medical devices were introduced in March 2023 (Regulation (EU) 2023/607) allowing longer periods for businesses to update their certifications.
Under this change, the dates for full compliance for “legacy devices” have been put back to 31 December 2027 (for most higher risk classifications) or 31 December 2028 (for other devices that require notified body involvement). Makers of class III custom-made implantable devices have access to a new transition period to 26 May 2026. Note that class I medical devices that did not and still do not require notified body involvement must already comply with the new rules.
The previously applicable “sell-off” deadlines have been removed.
While these extensions offer welcome relief to businesses, it is important to understand the details. Importantly, legacy devices may not undergo any significant change in the design or intended purpose after the date of application of the MDR, i.e. 26 May 2021, if they are to remain within the extended transition period. As discussed in updated guidance, this consists of two cumulative elements:
- there is a change in the design or intended purpose, and
- the change is significant.
If both of these are met, the change takes the legacy device outside the scope of the extended transition period and new certification will be required. Manufacturers should assess and document any changes, where appropriate involving the notified body, and may be required to make this evidence available to a competent authority.
Producers of devices that deploy software will need to take particular care over any changes, as updates and corrections are frequently made in this context. The guidance provides detail as to which changes are considered significant. For example, security updates including cyber-security enhancements are non-significant, while a new or major modification of architecture would be a significant change.
The European Association of Medical devices Notified Bodies (Team NB) issued a position paper on 10 August 2023. This recognises the difficulties that there have been with notified body capacity, but also highlights the need for manufacturers to engage early to avoid surges of activity as the deadlines approach. The paper points out the compliance challenge faced by the industry, with over 1,500 pages of applicable guidance and a lengthy process for approving new notified bodies.
The paper comments that “notified bodies welcome the generous extension of the transition timelines and are confident that they could transition all remaining certificates within the given timeframe” but point out that producers and regulators also need to do their part.
Learn more about our Life Sciences practice.
Our content explained
Every piece of content we create is correct on the date it’s published but please don’t rely on it as legal advice. If you’d like to speak to us about your own legal requirements, please contact one of our expert lawyers.