On March 20, 2023, the new transitional regime for medical devices in the EU and the EEA became effective when Regulation (EU) 2023/607 (the “Regulation”) was published in the Official Journal of the European Union. The Regulation provides for highly anticipated extensions of the transition periods under the EU Medical Device Regulation (MDR) and certain related provisions under the EU In Vitro Diagnostic Medical Device Regulation (IVDR).
The key elements of the Regulation are:
- An extension of the validity of certificates (MDR),
- An extension of the transition period (MDR), and
- The removal of time restrictions for sales (the “sell-off” periods) (MDR and IVDR).
The Regulation is based on the European Commission’s proposal released on January 6, 2023 (the “Proposal”), which was adopted by the European Parliament and the Council on February 16, 2023. This article provides a brief overview of the above-mentioned key elements of the Regulation. As the text of the Regulation has not changed from the Proposal during the legislative process, we refer to our recent article for a more detailed analysis of the content of the Regulation.
It should also be noted that the Regulation’s amendments to the IVDR are limited to the abolition of the sell-off period. The rest of the IVDR’s transitional regime remains untouched. We discussed the IVDR transitional periods in this article.
Extension of the transition period
The Regulation amends the transition periods provided for in Article 120 of the MDR. The extension is gradual and depends on the risk class of the device. The transition period is extended from May 26, 2024 to December 31, 2027 for higher risk devices (e.g., Class III and Class IIb implantable devices, except certain devices exempted by the MDR) and to December 31, 2028 for medium- and low-risk devices (e.g., other Class IIb devices, Class IIa devices, and Class I devices placed on the market in sterile condition or with a measuring function).
To ensure that only safe devices are placed on the market, the extension of the transition periods requires that certain conditions must be met:
- The devices must continue to comply with the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AMDD);
- There are no significant changes to the design and intended purpose;
- The devices do not present an unacceptable risk to the health or safety of patients, users, or other persons, or to other aspects of the public health protection; and
- By May 26, 2024 at the latest,
Extension of the validity of certificates
The validity of certificates previously issued under the MDD, which are valid on the date of application of the MDR (May 26, 2021) and have not been withdrawn by a notified body, will remain valid for the duration of the proposed extended transition period of the respective risk class applicable to the device as set out above, provided that the conditions above are met.
However, the Regulation does not address the formalities of an extended certificate. It is therefore unclear at this stage whether a new certificate or an amended certificate will be issued in the event of an extension, or on what other basis manufacturers can demonstrate that an otherwise expired certificate is in fact still valid. Manufacturers should watch out for forthcoming Q&A guidance documents addressing this issue.
Removal of the sell-off periods
The sell-off date requirement does not appear in the MDR and the IVDR. Therefore, devices placed on the market before the respective end of the transition period can continue to be available on the market without a legal time restriction.
The medical device industry and its stakeholders can breathe a sigh of relief. While it took some time for the European Commission and EU Member States to recognize that an extension of the transitional regime was imminent in order to avoid a European healthcare crisis and it was necessary to take action, the adoption of the proposal and its entry into force have been accomplished in an unexpectedly swift process.
However, while the time extensions provided by the Regulation may seem comfortable, manufacturers should be aware that important deadlines are fast approaching. Under each scenario, an MDR-compliant quality management system must be implemented and a formal application filed with a notified body by May 26, 2024. Of course, it can be expected that there will be a massive run on notified bodies at the end of this period. Thus, manufacturers would be well advised to prepare and submit their applications as soon as possible. Watch this space for further updates on this and other EU regulatory issues.