2019年 10月 15日
On October 4th, 2019 the Medical Devices Coordination Group (MDCG) issued a guidance document on the validity of certificates issued under the (Active Implantable) Medical Devices Directive (AIMDD), following the Date of Application of the Medical Devices Regulation (EU) 2017/745 (MDR). These so-called “legacy devices” can be placed on the market until the certificate expires or until May 26, 2024, whichever comes first.
According to the new guidance, manufacturers can place legacy devices on the market under specific conditions, some of which are specified by MDCG. The Notified Body that issued the certificate must remain designated for the AIMDD and MDD for as long as it wants to keep up its surveillance activities. Member States must therefore keep monitoring these Notified Bodies for the Directives. Manufacturers must of course have an agreement with their AIMDD/MDD Notified Bodies to ensure ongoing surveillance activities. An important condition for this would of course be the Notified Body’s continuation of their activities.
There are two issues that are not addressed in this guidance document:
All this means that many companies cannot fully rely on the continuity of their certifications, unless they have already certified their devices under the MDR. It is recommended that manufacturers communicate well with their Notified Bodies, follow developments and prepare their legacy files for an early transition to the MDR.