MDCG Recommends Limits on Article 97 MDR Applications by EU Member States

By Annette Van Raamsdonk

European regulators are recommending that European Union member states should limit use of Article 97 Medical Devices Regulation (MDR) to particular circumstances involving legacy medical devices now that amendments extending MDR transition periods have been published.

On July 1, 2023 the Medical Devices Coordination Group (MDCG) published an addendum to the previously published MDCG 2022-18 MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate.

In short, the addendum clarifies that with the adoption of the amendment to the MDR, Regulation (EU) 2023/607, the application of Article 97 MDR by EU member-states should be limited to “very exceptional situations”.

What was MDCG 2022-18 about, again?

MDCG 2022-18 was published December 2022, and aimed at avoiding disruption of the supply of devices in the EU and avoiding discontinuation of healthcare as a result of an expected bottleneck of expiring certificates by May 26, 2024.

MDCG 2022-18 was a guide for manufacturers and EU Member-states “to achieve a common understanding of and a uniform approach to the application of Article 97 of Regulation (EU) 2017/745 on medical devices (MDR) in situations where a device is not in conformity with the MDR because its certificate issued under Directive 93/42/EEC (MDD) or Directive 90/385/EEC (AIMDD) has expired or expires before issuance of the necessary certificate(s) in accordance with the MDR.”

Article 97(1) MDR allows manufacturers and EU Authorized Representatives to request that a Competent Authority (CA) permits a device on the EU market that is not (yet) fully compliant with the MDR. Before the amendment to extend the MDR transitional provisions was published (Regulation (EU) 2023/607), legacy devices that had not yet received the final CE certificate to the MDR, while the MDD or AIMDD certificate had already expired, were no longer allowed on the market in the EU.

Article 97 MDR decisions could be issued by CAs to allow a device on the EU market for a limited time until the MDR certificate is issued or any non-compliance issue was solved. Article 97 MDR was intended as a bridging solution until Regulation (EU) 2023/607).

With the publication of Regulation (EU) 2023/607 on March 20, 2023, MDCG 2022-18 lost its main purpose: “avoiding disruption of supply of devices on the EU market needed for health systems and patients”.

The addendum that has been added to MDCG 2022-18, states that Article 97(1) MDR decisions should only be made in very exceptional situations.

What if I am not eligible for the amendment (Regulation (EU) 2023/607)?

With the publication of Regulation (EU) 2023/607 and the addendum to MDCG 2022-18, the MDCG clearly discourages Article 97 MDR requests by manufacturers.

However, there are still (exceptional) situations in which the manufacturer falls between two stools. In such cases, Emergo by UL urges manufacturers (at all times) to work on MDR compliance. This starts with working to get an MDR Notified Body agreement in place as soon as possible and compiling your MDR QMS and Technical Documentation.

 If your devices are:

• legacy devices
• not covered by Regulation (EU) 2023/607
• expressly needed by healthcare providers
• there is no alternative available

and the devices do not present unacceptable risks to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, a derogation request based on Article 59 MDR might be a solution to ensure the continuation of healthcare while working on MDR compliance.

Emergo by UL consultants in Europe can assist with getting a Notified Body agreement in place, article 59 MDR support and related MDR certification and compliance efforts.