On January 06, 2023, the European Commission (EC) published a proposal for the extension of the MDR (Medical Device Regulation) transition periods. This proposal was already adopted on February 16, bringing the extension into force. The obligation of medical device manufacturers to be MDR-compliant was thereby postponed several years into the future. reason for this decision was the MedTech industry’s fear that many companies would be unable to meet the original deadline. As a result of the previous deadlines, many medical devices would have lost their marketing authorization, ultimately, with serious consequences for patients in need.
The extension of the deadlines also raises several other questions. Why else does the EC consider it necessary to postpone the deadlines? What does this mean for manufacturers and users of medical devices? What does it have to do with the EUDAMED deadlines? In this article, we would like to get to the bottom of these questions.
Shortage of Notified Bodies
One of the main reasons for the extension of MDR transition periods is the low number of Notified Bodies. As independent organizations, they verify the conformity of medical devices. When the extension proposal was published, there were 36 Notified Bodies in the EU. By comparison, there were 59 Notified Bodies under the Medical Device Directive (MDD) in 2017 and as many as 78 in 2013. Less capacity for medical device conformity assessment leads to prolonged wait times. As of October 2022, requests were filled for 8,120 conformity assessments, while only 1,990 certifications have been awarded. Also, there are a total of 21,376 previously known legacy devices that could be waiting for certification in the future. Because of this discrepancy, experts estimate that the Re-certifications would not be completed until December 2027. However, the EC announced that applications for 26 additional Notified Bodies are currently under review.
To avoid a shortfall in patients’ care, the proposal to extend the MDR transition deadlines has been adopted by the European Commission. The new deadlines are as follows:
|Product classes||Old date||New date|
|Class Is, Im, Ir||–||December 31, 2028|
|Class IIa||May 26, 2024||December 31, 2028|
|Class IIb non-implantable||May 26, 2024||December 31, 2028|
|Class IIb implantable||May 26, 2024||December 31, 2027|
|Class III||May 26, 2024||December 31, 2027|
Only legacy devices are affected by these dates, i.e., those with a certificate or declaration of conformity issued before May 26, 2021, under European Council Directives 90/385/EEC or 93/42/EEC. In addition, there are important conditions attached to the new deadlines:
- Still compliant with MDD/AIMDD
- No significant change to the product
- Product does not pose an unacceptable risk to patients
- Quality management system according to Article 10(9) established by 26.05.2024 at the latest
- Conformity assessment according to MDR requested by 26.05.2024, written agreement with a Notified Body no later than 26.09.2024
In the context of this decision, the previously established sell-off deadline of 27 May 2025 was deleted, as it also entailed the risk of a supply shortage. Manufacturers can now sell medical devices already placed on the market before 26 May 2021 without any time restriction and do not have to worry about a recall or possible disposal.
Furthermore, it should be mentioned that the deadlines for UDI marking remain unchanged.
What is important now?
Even though the transition periods have been postponed, that does not mean that manufacturers can now rest. Considering that the conformity assessment has been requested for only 8,120 products so far, there may be another backlog. This number does not even represent half of the 21,376 medical devices that have been approved for the market under the Active Implantable Medical Devices Directive and the Medical Devices Directive. Although the capacities of the notified bodies have been increasing and will increase by non-legislative measures and the 26 outstanding notified bodies will presumably be accredited soon, the deadlines of the transition periods are nevertheless tight.
Even though the transition deadlines have been pushed back, it is still important to collect the necessary data on your products now. While the deadline for the conformity assessment has moved further into the future, the live date of EUDAMED remains the same. The data of the medical devices currently have to be entered into the database several years before their MDR certification. With our software solution mytracekey MedTech we can help you to manage your product data efficiently and easily achieve MDR compliance.[Disclaimer]
This information is only one possible interpretation of the regulations. They are also in a constant state of change, so the information in this article may be incomplete or out of date. The above article is expressly no legal advice. Please refer to the official documents for information before making any business decisions. (Status of information: April 2023)