📌 We have held our meeting regarding the European Union decision published on 20.03.2023 on the approval of the extension of the #MDR Transition Process. The important points regarding this meeting are as follows;
A much-awaited extension of the MDR transition period became effective today with the publication of Regulation (EU) 2023/607 in the Official Journal of the European Union. Starting 20.03.2023, manufacturers of MDR legacy devices may benefit from longer deadlines to certify their products.
In a nutshell, Regulation (EU) 2023/607 introduces the following main changes:
-Extension of #MDR transition period until
(a) 26 May 2026, for class III custom-made implantable devices;
(b) 31 December 2027, for class III and class IIb devices (with some exceptions);
(c) 31 December 2028, for class IIa, IIb devices (not covered by point b), class I sterile devices or with measuring function, as well as devices qualified as class I under the directives but which conformity assessment procedure under the MDR requires the intervention of a Notified Body.
-Removal of the “sell-off” period in the #MDR and IVDR.
The extension of the transition period meets the demands of the medical device industry, which has long been calling for a more flexible deadline to certify #MDR legacy devices. However, Regulation (EU) 2023/607 provides that these measures should not be applied indiscriminately but only to those companies that have already embarked on the path of MDR compliance. In this sense, manufacturers must (i) implement the QMS and (ii) submit a formal application to a Notified Body by 26 May 2024. By 26 September 2024, manufacturers must enter into an agreement with the Notified Body for the conformity assessment. In light of the above, the extension of the transition period is undoubtedly good news for medical device manufacturers. However, the need to meet the first deadline (by 26 May 2024) requires prompt action to ensure compliance with the new rules.
