European Commission proposes action on transition to the Medical Devices Regulation

Proposal for an amendment to the MDR and IVDR published

The European Commission’s Medical Device Coordination Group (MDCG) survey on notified body certification and application activities under the Medical Devices Regulation (EU 2017/745) (MDR) and In Vitro Medical Devices Regulation (EU 2017/746) (IVDR) showed the problems in the transition to the MDR and IVDR. A significant number of certificates for legacy medical devices expire on 26 May 2024. At the current rate of certification, all existing products cannot be transitioned by the current deadline. On 6 December 2022, the European Commission indicated that it was prepared to present a proposal to amend the MDR to provide more time for transition. The proposal was published on 6 January 2023.

The Commission proposal notes that the overall capacity of notified bodies remains insufficient to carry out the required conformity assessment tasks. In addition, it notes that many manufacturers were not ready to meet the requirements of the MDR by the end of the transition period. These factors were considered to present a threat to the availability of medical devices on the EU market. The overall goal of the proposed amendments is to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new regulations. The extension will be staggered depending on the risk class of the device - until December 2027 for devices with a higher risk and until December 2028 for medium and lower risk devices and for devices requiring the involvement of a notified body for the first time and where the declaration of conformity was signed before 26 May 2021 (e.g. for class I reusable surgical instruments or some software as a medical device). There are conditions associated with these extensions, including that the manufacturer must have taken steps to transition to the MDR in order to benefit from the additional time. It also proposes to delete the deadline in both the MDR and IVDR for making available of devices which are placed on the market before or during the transition period and which are still in the supply chain when the extended transition period is over.

The proposal is to amend Article 120(2) of the MDR. This would extend the validity of certificates issued under the Directives for active implantable medical devices and medical devices (90/385/EEC or 93/42/EEC) that were valid on the day of the MDR’s date of application (26 May 2021) and have not been withdrawn by a notified body. The extension is directly applicable – notified bodies are not required to change the date on the individual certificates.

For certificates that have already expired when the proposed amendment comes into force, the extension would be subject to the condition that, at the moment of the expiry, the manufacturer has signed a contract with a notified body for the conformity assessment of the device in question or a substituting device under the MDR or a competent authority of a Member State has granted a derogation or required the manufacturer to carry out the applicable conformity assessment procedure in accordance with the MDR.

In addition, it is proposed that the transition period is extended from 26 May 2024 until:

• 31 December 2027 for higher risk devices (class III and class IIb implantable devices except certain devices for which the MDR provides exemptions for devices considered to be based on wellestablished technologies), and
• 31 December 2028 for medium and lower risk devices (other class IIb devices, class IIa devices and class I that are sterile, have a measuring function, are reusable surgical instruments or some software as a medical device.)

The extended transition is subject to the following proposed conditions:

• devices continue to comply with the applicable Directives;
• devices cannot have undergone any significant changes to design or intended purpose;
• devices cannot present an unacceptable risk to the health and safety of patients, users or other persons, or to public health;
• no later than 26 May 2024, the manufacturer has put in place a quality management system in accordance with the MDR; and,
• no later than 26 May 2024, a formal application has been submitted under the MDR for conformity assessment for a legacy device covered by a Directive’s certificate or declaration of conformity, or for a device intended to substitute that device under the MDR, and, no later than 26 September 2024, the notified body and the manufacturer have signed a written agreement for MDR application. 

This is currently a proposal but is expected to be finalised and published in the Official Journal in the near future. Manufacturers should monitor its progress. Manufacturers should also ensure that they are in discussion with the notified bodies regarding the conformity assessment of any devices that could be subject to the extended transition.