Last week marked a significant development in the complex implementation of the new EU medical devices legislation, the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). At the request of the EU Member States’ Health Ministers, who are part of the Employment, Social Policy, Health, and Consumer Affairs (EPSCO) Council, to avert a crisis in the supply of medical devices, the European Commission (Commission) will be proposing a delay to some aspects of the MDR and IVDR.
On Friday last week, Commissioner for Food and Health Safety, Stella Kyriakides, presented the Commission’s planned proposal to EU Health Ministers, which was submitted in its briefing note to the Council ahead of the meeting. This proposal follows the persistent calls of the EU Health Ministers — alongside those of industry — highlighting the severe challenges in the implementation of the MDR and IVDR at the EPSCO Council in June 2022, which the Commission had committed to address at the meeting on December 9, 2022. The challenges have arisen primarily from the lack of access to, and capacity of, Notified Bodies, which are required to certify devices for conformity under the new framework.
With its presentation to the EU Health Ministers, the Commission outlined targeted amendments to the MDR and IVDR, to be presented as a draft legislative amendment in early 2023. In summary, the proposal is expected to do the following.
For the MDR:
- Extend the transitional period in Article 120(3) for legacy devices:
- until 2027 for Class IIb and III devices (from the current May 26, 2024)
- until 2028 for unclassified Class I and II devices (from the current May 26, 2024)
- Provide for a conditional extension of validity period for CE certificates issued under the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD), on the conditions that:
- the device does not present an unacceptable risk to health and safety
- the device has not undergone significant changes in design or intended purpose
- the manufacturer has already undertaken the necessary steps to launch the certification process under the MDR (such as adaptation of its quality management system to the MDR).
- Remove the “sell off” provision in Article 120(4) that currently permits devices certified under the MDD and AIMDD regime to be placed on the market only until May 26, 2025.
For the IVDR:
- Remove the “sell off” provision in Article 110(4) that currently permits devices certified under the In Vitro Diagnostic Medical Devices Directive regime to be placed on the market only until May 27, 2025.
While these measures are welcome, the need for a separate review to extend the MDD and AIMDD certificates is still worrisome as this will continue taking away valuable resources from manufacturers’ MDR certification activities. In addition, no extensions were discussed with respect to IVDR timelines at this stage, so this may be a topic of concern and future changes.
The Commission also proposes improvements to the CE certification process for innovative devices. It commits to be working with the Medical Devices Coordination Group (MDCG) to address the structural problems of the MDR, with a priority to find solutions for “orphan” devices, expected to cover, for example, those intended for paediatric patients or patients with cardiovascular diseases. Moreover, to foster innovation, a pilot project will be launched in early 2023 to offer scientific advice from the expert panel to manufacturers of orphan and breakthrough devices. More support for small and medium-sized enterprises and first-time applicants to Notified Bodies was also discussed. Industry will warmly welcome these initiatives.
The Member States generally expressed support for the proposals. Some specific comments included:
- A 2027 review of the MDR should be used to evaluate further measures
- Special attention should be paid to Class III devices
- Collective efforts should be taken to increase Notified Body capacity
- Without appropriate measures being taken, it was acknowledged that manufacturers would look to other markets
Other important measure: MDCG Position Paper on Article 97 MDR
Also recently, the MDCG produced a Position Paper (MDCG 2022-18) on the application of Article 97 MDR. Article 97 covers nonconformity situations where a device’s certification under MDD or AIMDD has expired before issuance of the necessary certificate under MDR, leading to a period of noncompliance. The Position Paper seeks to provide for a uniform approach to this period for affected devices, meaning these legacy devices may be able to stay on the market even once their MDD/AIMDD certificates have expired.
According to the Position Paper, if a national competent authority (NCA) is satisfied that:
(i) a noncompliant device does not present an unacceptable risk to the health or safety of patients or users (pursuant to Article 94 MDR), and
(ii) the manufacturer has already taken reasonable steps to transition its device to the MDR (having had an application for conformity assessment accepted by a notified body),
then the NCA may issue a communication to the manufacturer defining the timeline in which it must bring the device into compliance with the MDR (no longer than 12 months).
The main takeaway from the Position Paper is that the MDCG has confirmed that this written communication should be recognized by other NCAs as evidence that a manufacturer may place a nonconforming device on the market for a limited period of time. In practice, this means that manufacturers will not have to apply to multiple NCAs for a derogation under Article 97 MDR. The NCAs are to agree a standard form of this communication in due course.
The Commission is expected to issue a draft legislative proposal in early 2023 to extend some of the transitional provisions of the MDR and the IVDR, containing the points outlined above.
Manufacturers should stay informed about the forthcoming changes and should analyze how these may affect their operations. For example, the removal of the sell-off provisions under the MDR and IVDR means that the much-debated and unclear “placing on the market” requirement may be less of a concern.
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