MDCG 2022-11
The EU MDCG have published a Position Paper titled “Notice to manufacturer to ensure timely compliance with MDR requirements”. In summary, the document is really a stern warning to manufacturers who have not yet transitioned to the EU MDR, making it clear that those products which do not comply with the regulation requirements before 26 May 2024 or before the expiry date of their valid MDD certificate will not be allowed on the EU market.
The MDCG clarify that the intention of the transition period introduced by means of Article 120 is to “further time to the system to prepare and to get ready, for example time for manufacturers to prepare their quality management system (QMS) and technical documentation before applying to a notified body” and “should not be perceived as a ‘grace period’ to postpone the entering into application of the new rules.”
Using data collected by Notified Bodies and Competent Authorities, close to 37% of applications under the MDR have been refused on the basis of ‘incomplete applications’ which shows many manufacturers are unprepared. Furthermore, in April 2022, 75% of Notified Bodies indicated that over 50% of applications were deemed to be incomplete.
This is not surprising. We are aware that many manufacturers who have been placing their products on the market for decades are trying to rest on their laurels to continue selling under the MDR. The problem is that without sufficient data, this is highly unlikely, and we encourage manufacturers who have some time left under their MDD certificates to collect as much post-market clinical data as possible. The key here is to collect meaningful clinical data on your devices, especially if these are within a higher risk category. Even so, your Notified Body may require further data in order to demonstrate clinical safety and performance.
Something else to keep in mind is that Notified Bodies have an ever-increasing timeline for MDR assessment due to a lack of resources. This implies that if one were
to lodge an application with one of the Notified Bodies in 2023, they may not receive their MDR certificate before 26 May 2024. Certain Notified Bodies have been notifying their clients that through their standard service, the deadline for submission of technical documentation for MDR assessment is 1 October 2022, that is a timeline of over a year and 6 months to receive your MDR Certificate (i.e. if there are no issues with the submission).
We cannot stress this enough. If you have not transitioned the technical documentation for your legacy products to the MDR yet, you are already late. We urge you to divert additional resources to meeting these requirements; once you are over this first regulatory hurdle, you should be in a good place in maintaining your position on the market.
Advena can help in various ways. Whilst we encourage you to contact us directly, here are a few services which we can provide you with:
- Initial consultation.
- EU MDD-MDR Gap Analysis.
- EU MDR-compliant technical documentation.
- Training
- Quality Management System updates to meet Article 10 requirements.
- Eudamed registrations.
- UDI consultation.
