The European Commission has proposed revising Regulation (EU) 2017/745 on medical devices (MDR) to extend the transitional periods envisioned by the Regulation in response to the growing challenges faced by a variety of stakeholders in the medical device space.

Stella Kyriakides, the European commissioner for Public Health and Food Safety, emphasized the need for immediate legislative action at the EPSCO.

The majority of health ministers from EU member states acknowledged the urgent need to extend the MDR's transitional periods and welcomed the proposed amendments.

The European Commission's proposes expansion of the momentary time of the MDR.

The ongoing temporary time frames gave in the MDR require clinical gadgets for which CE authentications of congruity have been given as per the Clinical Gadget Mandate (MDD) or the Dynamic Implantable Clinical Gadget Mandate (AIMDD) (the Orders) to be re-ensured based on the MDR by 26 May 2024.

If devices are not recertified by this date, they may not be legal to sell in the EEA. In any case, the last CE certificate of conformity issued in accordance with the Directives will be on May 26, 2024.

The Information Note that was released prior to the EPSCO meeting states:

By the end of 2022, approximately 6% of the 22,793 certificates issued in accordance with the Directives will have expired, and 19% will have expired in 2023; in addition to the remaining 75% during the first five months of 2024.

There is a growing possibility that these devices will not be recertified before the end of the current transition period due to the number of expired certificates and the current oversubscription faced by notified bodies designated to the MDR. Based on the risk classification of each device, the European Commission has therefore proposed extending the transition period outlined in Article 120.3 of the MDR.

The proposal made by the Commission states:

The risk classification of the devices will determine how much longer the transition period will be:

The sell-off date currently provided in Article 120.4 MDR will be removed. High risk devices (Class III and Class IIb) will be required to conform to the MDR by 2027 at the latest. Medium and low risk devices (Class IIa and Class I) will be required to conform to the MDR by 2028 at the latest. As a result, devices that were previously sold in the EEA on the basis of CE conformity certificates issued by the Directives may continue to be sold in the EEA.

Benefits from the MDR's transitional period will still be subject to restrictions. In addition to not posing an unacceptable risk to health and safety, the device must not have undergone significant design or intended purpose modifications. In addition, the manufacturer must have begun the necessary steps to ensure that the device complies with the MDR before the stipulated deadline.

A position paper on the application of Article 97 of the MDR, prepared by the Medical Device Coordination Group (MDCG), was published following the EPSCO Council meeting, in addition to the targeted legislative measures proposed by the European Commission.

To bridge the gap between the expiration of CE certificates of conformity issued on the basis of the Directives and the issuance of new certificates on the basis of the MDR, the purpose of the paper is to ensure a uniform approach to the application of market surveillance measures.

The paper provides guidance regarding the extension of the validity of CE certificates issued in accordance with the Directives that is non-binding and, as experience suggests, will be respected.

In addition, the European Commission has stated that it will conduct a comprehensive evaluation of the MDR by May 2027.

The evaluation's objective is: to discover the Regulation's structural flaws;

Determine whether the Regulation has served its legislative purpose or harmed patient safety, public health, or medical advancement; and offer potential solutions for these issues in the medium and long term.

Next Steps Stella Kyriakides, the EU Commissioner for Health and Food Safety, has stated that the legislative proposal from the European Commission will be presented to the European Council and European Parliament for consideration in early 2023.

Additionally, the European Commission intends to provide solutions for orphan devices and to support the MDR's implementation through the EU4Health Program beginning in early 2023.

The proposal from the European Commission is an essential step toward reducing the possibility of jeopardizing patient access to certain life-saving medical technology.

However, it is uncertain whether or not the in-progress proposals to the European Council and European Parliament will address unresolved issues such as the removal of the sell-off point for in vitro diagnostic medical devices covered by the in vitro diagnostic medical devices Regulation and the extension of the validity of CE certificates.