Description: The date of application (DoA) has long passed, yet many lingering questions remain on what precisely constitutes appropriate surveillance under the Transitional Provisions of the MDR. Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR) state that devices which have a valid certificate issued by a notified body (NB) under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market or put into service after the DoA of the MDR under certain conditions and no later than 26 May 2024. The conditions for these 'legacy devices' (as defined by MDCG 2021-25) require that the NB that issued the certificate under the MDD or the AIMDD continues carrying out appropriate surveillance in respect of all of the applicable requirements relating to the devices it has certified. This session will share some of our experiences as Notified Body with appropriate surveillance (and the associated guidance document to be released in early/mid 2022) under Article 120(3). It will enable manufacturers to have a better understanding of the elements expected to be verified by NBs, as well as the requirements and obligations for manufacturers and their QMS in order to minimize the risk with their existing legacy device certifications.
Learning Objectives:
Provide an overview of the key audit and surveillance activities under the 'Appropriate Surveillance' guidance
Describe the requirements for Manufacturer's QMS & QMS Documentation Review under Article 120(3) and which requirements for appropriate surveillance are applicable to 'Legacy Devices'
Learn about Notified Body experiences to date with appropriate surveillance under Article 120(3)