Article 97 Application Limitations

The European Medical Device Coordination Group (MDCG) have issued a recommendation for limiting the number of Article 97 applications for legacy devices as a result of the Article 120 transitional provision extensions.

European regulators are advising European Union member states to restrict the use of Article 97 of the Medical Devices Regulation (MDR) to specific circumstances involving legacy medical devices. This recommendation comes after amendments extending MDR transition periods were published. On July 1, 2023, the Medical Devices Coordination Group (MDCG) issued an addendum to the MDCG 2022-18 Position Paper. This addendum clarifies that following the adoption of the MDR amendment, Regulation (EU) 2023/607, the application of Article 97 MDR by EU member states should be limited to “very exceptional situations.”

This puts extra strain on certain manufacturers hoping to get through this route.

We’ve assisted our clients through this process before. Should you require an Authorized Representative who can guide you appropriately, please get in touch at info@specculo.com