UPDATE: On July 2023 the European Commission has additionally published a updated Q&A document on the extension of the timelines. The information can be found on the EC website:
The new regulation newly regulates the validity of AIMDD and MDD certificates and defines requirements for the first placing on the market of "legacy devices" (as per MDCG 2021-25), even if the validity of the underlying certificates according to the directive (MDD or AIMDD) has formally expired.
Overview of the changes:
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Extension of the transitional periods for the first placing on the market of devices based on certificates according to MDD or AIMDD, for all devices for which an application for certification (see below) according to MDR was submitted before the expiry of the MDD certificate until 31 Dec. 2027 (Class III and implantable devices Class IIb [with exceptions]) or until 31 Dec. 2028 (all other devices).
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Extension of the transition period for class I devices (MDD) that are classified higher under MDR until Dec. 31, 2028.
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Extension of transition period for Class III custom-made devices until Dec. 31, 2027.
For these devices (except custom-made devices), the manufacturer must have established a QM system according to MDR by 26 May 2024 at the latest. The second, essential prerequisite for being able to benefit from the extended timelines is a written contract between the manufacturer and the notified body for certification according to MDR (certification contract). This contract must be applied for at the latest before the expiry of the MDD certificate and must cover all products for which the extension of the transitional periods is to be claimed. The basis of the contract is the availability of the technical documentation in accordance with the requirements of the MDR.
In order to be able to submit an application for certification - either initial MDR certification or extension of the MDR certification for new device groups - we require a questionnaire (initial certification) or an amended list of medical devices (a notification of change alone is not sufficient). On this basis, we will provide you with an offer for certification. This offer is the basis for your application for certification and subsequently for the final certification contract. We will implement the requirements for the contract in such a way that, together with the application for certification, at least one complete technical documentation must be submitted for review in addition to the documentation of the QM system. The technical documentation according to MDR requirements for the other products covered by the certification contract must also be available at the time of application, but can be submitted for review at a later date according to an agreed plan.
In order to be able to issue the confirmation letter proposed by the EU Commission, a contract for the monitoring of the (formally expired) MDD certificates must also be concluded. On the basis of this communication this confirmation letter can be issued confirming that products may continue to be placed on the market with the CE mark and mdc's identification number 0483. We are preparing the corresponding application procedure and will make them available as soon as possible.
Alternatively, the manufacturer (or his European authorized representative) can apply for an exemption according to Art. 97 MDR at the responsible market surveillance authority, this is independent of the status of the MDD certificates.
Another significant change is also the elimination of the sell-by period for medical devices and In- vitro Diagnostic Devices placed on the market under AIMDD, MDD and IVDD.
You can also find the text of the regulation at
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32023R0607