Combined audits MDD/AIMDD and MDR : requirements and impact on the quality management system

The date after which “legacy devices” can no longer be placed on the market or put into service pursuant Medical Device Directive 93/42/EEC (MDD) and the Active Implantable Medical Device Directive 90/385/EEC (AIMDD) has been extended following the publication of Regulation (UE) 2023/607.

Hence, a lot of manufacturers will have coexisting in their product portfolio “legacy devices” and devices certified under the Medical Device Regulation (UE) 2017/745 (MDR) for a longer period.

Combined audit can then become an exercise to discriminate the requirements between devices covered by MDD/AIMDD and devices undergoing an MDR conformity assessment procedure, or devices already certified under the regulation.

This newsletter is intended to explain the requirements of combined audit and its impact on the quality management system (QMS).