To begin, a cautionary statement...
The MDR transition timeline extension is not automatically applied to every legacy device! The timeline extension is conditional in nature, and there are a few key requirements that must be satisfied before manufacturers can benefit from this extension.
It is important to note that the extension is designed to enable notified bodies (NB) to have sufficient time to assess applications, not to enable manufacturers to delay their submissions. To this end, the extension includes two critical deadlines for manufacturers:
- 26 May 2024, by which time manufacturers must have lodged an MDR application with their NB
- 26 September 2024, by which time the NB must have accepted this application.
These interim deadlines are intended to prevent another crunch point of late applications as the new deadlines approach.
What to do
By getting the applications in now, NBs can plan effectively for their certification workload over the next few years, ensuring a smoother transition process. However, if you miss either of these deadlines, you will not be able to benefit from the timeline extensions; this may also impact your registrations in other countries if EU compliance was required for market access.
If you have not yet identified a notified body and submitted your application, or if your application has not yet been accepted, please note that acceptance of the MDR application is not a given: there are several strategic and tactical activities to be completed between now and 26 May 2024 to ensure a successful application.
If you are less confident and even slightly concerned about the conditional nature of the transition timeline and your company’s readiness, here are some critical items to consider:
- Evaluate your product portfolio to determine if you are truly eligible for the MDR transition timeline extension. The EU Commission has published helpful guidance document here, to supplement the Q&A guidance on the extension published earlier this year.
- Ensure your NB application includes all information they require to provide a quote. Common pitfalls include gaps or inconsistencies in or relating to:
- The device description and intended purpose, including mode of action and elements which may require additional specialist consultation procedures (e.g. medicinal substances, animal tissues, Artificial Intelligence, etc.);
- Closely related to the above, device classification and justification;
- Critical subcontractors, their roles, and current state of QMS certification;
- Marketing or other claims which may impact the need for a clinical evaluation consultation procedure.
Omissions or inaccuracies in the above can lead to a delay of many months in quoting and ultimately acceptance of your application for MDR certification.
- Ensure your documented QMS is in compliance with the MDR requirements, considering EN ISO 13485:2016+A11:2021, prior to 26 May 2024, and that you have evidence of effective implementation.
- Ensure additional requirements for manufacturers and economic operators as described in Articles 10 – 15 are addressed and you have appropriate evidence of compliance.
- Ensure MDR post-market requirements (per Article 120) are fulfilled, and there is evidence of compliance beginning no later than 26 May 2021.
These elements are not only essential to be able to continue to place your device on the market, but they will also form the necessary framework for any updates or remediation activities needed to achieve MDR certification.
For next steps and more information, here are two fantastic options from our Knowledge Center:
- Read our guide: Mastering the Transition: 5 Essential Tips for EU MDR Compliance
- Watch BSI's Richard Holborow and RQM+'s Amie Smirthwaite discuss EU compliance in RQM+ Live! #69