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European MDCG Clarifies Market Access Requirements for Legacy Devices Under Article 97 MDR

An MDCG position paper explains the process for obtaining permission to sell legacy devices in European Union member states according to Article 97(1) MDR

European Union

December 13, 2022

By Annette van Raamsdonk

The European Commission’s Medical Device Coordination Group (MDCG) has published a guidance document covering the application of Medical Devices Regulation (MDR) provisions allowing legacy medical devices not yet certified under the new Regulation to remain on the European market for set periods of time.

The position paper, MDCG 2022-18, clarifies Article 97(1) MDR, which allows manufacturers and European Authorized Representatives to request that an EU Competent Authority (CA) permit sales of devices that do not yet fully comply with the MDR, such as legacy devices that have not yet received final CE certification to the MDR but whose certifications under the Medical Devices Directive (MDD) or Active Implantable Medical Devices Directive (AIMDD) have already expired. The new MDCG document aims for a harmonized approach to how CAs handle Article 97 MDR requests, including rules for limiting the scope of such requests to individual EU member states, in order to allow devices to remain on the European market for set periods of time.

It should be noted that Article 97(1) MDR differs from Article 59 MDR, under which derogation of a legacy device is granted only for specific healthcare providers, institutes or patients.

Alleviating Notified Body bottlenecks

MDCG 2022-18 aims to avoid potential disruptions to medical device supplies in the EU, and clearly addresses Notified Body bottlenecks that have led to delayed issuance of CE Mark certificates, resulting in noncompliant devices. The guidance document describes how CAs intend to apply Article 97 MDR in a legally sound, coherent and consistent manner.

Furthermore, the position paper describes which documentation a manufacturer and/or Authorized Representative should provide to their leading CA (that is, the CA of the EU member state where the manufacturer or Authorized Representative is based) in order to qualify for Article 97 MDR, and to ensure that the leading CA is able to perform its tasks according to Article 94 MDR, as well as evaluate whether a device poses unacceptable risk. Once a manufacturer or Authorized Representative obtains permission from a leading CA for its device, the leading CA will inform the EC and other EU member states of its decision. If none of the other member states have objection to the leading CA's decision, the device will be allowed to remain on the EU market under certain conditions. A request for derogation based on Article 59 MDR is no longer required once Article 97 MDR permission has been granted.

Stakeholders should be aware that:

  • MDCG 2022-18 only applies to legacy devices that fall under the scope of Article 120(3) MDR and for which MDD or AIMDD certificates have expired or will expires prior to the issuance of necessary MDR certificate(s).
  • Regardless of a leading CA’s decision regarding an Article 97 MDR request, other CAs may make different decisions as to whether a particular legacy device may remain on the market in their jurisdiction.
  • Annex I of MDCG-18 contains a checklist for the application of Article 97 MDR.

Market access allowance under Article 97 MDR may only be used for limited time periods until a device's MDR certification is issued or any non-compliance issues are resolved. Article 97 MDR permissions may also be used as bridging solutions until the proposal to extend MDR transition periods is published (which is anticipated for January 2023).

Annette van Raamsdonk is Lead Quality & Regulatory Affairs Consultant at Emergo by UL in The Netherlands. She represents the European Authorized Representatives in several MDCGH working groups and previously worked at the Dutch CA.