In brief
On 16 February 2022, the Medical Device Coordination Group (MDCG) approved a new document (i.e., MDCG 2022-4) to provide guidance to Notified Bodies on the appropriate way to carry out surveillance activities on CE-marked devices in accordance with the Medical Devices Directive 93/42/EEC (“MDD“) and the Active Implantable Medical Devices Directive 90/385/EEC (“AIMD“), which, by virtue of the provisions of Article 120(3) of Regulation EU 745/2014, can be marketed until 26 May 2024.
Key takeaways
- In particular, the document provides detailed instructions on surveillance activities that Notified Bodies are required to carry out in order to review the Quality Management System documentation, adopted by manufacturers who continue to use the market devices certified according to the aforementioned Directives.
- In this regard, the document specifies that Notified Bodies must verify whether (i) the scope of devices covered by the MDD or the AIMD certificates remains, or if and which devices are discontinued; (ii) the manufacturer has adjusted its Quality Management System according to the requirements of Article 120(3) MDR concerning significant changes; and (iii) the manufacturer has made the necessary adjustments with respect to the Quality Management System on post-market surveillance, market surveillance, vigilance, and registration of economic operators and devices.
