A European Union (EU) task force has issued a document intended to clarify the application of the EU’s Medical Device Regulation (2017/745, also known as the MDR) post-market surveillance requirements to legacy medical products.
Published by the Medical Device Coordination Group (MDCG), the document, MDCG 2021-25 is intended to provide a “legally defendable and pragmatic” position on requirements applicable to medical devices placed on the market prior to May 26, 2021, the date on which the requirements of the MDR came into full effect. The document is intended to address a large number of products that were placed on the market prior to that date in accordance with the EU’s Medical Device Directive (90/385/EEC).
In brief, the document concludes that all relevant MDR requirements related to post-market surveillance, market surveillance, and vigilance are equally applicable to legacy devices and that manufacturers of legacy devices must continue to issue periodic safety update reports (PSURs) in connection with their products.
The MDCG was established under Article 103 of the MDR and is comprised of representatives from all EU Member States. However, the document and its findings do not reflect the official position of the European Commission and are not binding under EU law.