The medical device Regulation (EU) 2017/745 (MDR) came into force in 2017 to supersede the MDD (Medical Device Directive) and AIMDD (Active Implantable Medical Device Directive). The development of this new regulation was focused on addressing perceived shortcomings of the directives and the overall aim was to better ensure the safety of medical devices. This led to an expansion of the requirements for economic operators, notified bodies and the overall regulatory process of conformity assessment. The introduction of MDR also defined a transition period split into several sequential phases and with specific provisions for different device risk classes.
By the end of this transition period, all products needed to be certified under MDR, including all legacy devices previously placed on the market under MDD and AIMDD, that are safe and fulfill the new requirements.
In March 2023 the amending Regulation (EU) 2023/607, that extends the transitional provision, was published. This allows for additional time for manufacturers to submit their application for MDR and simultaneously introduces a set of pre-conditions for manufacturers to qualify for the extension.
Notified bodies welcome the generous extension of the transition timelines and are sure that they could transition all remaining certificates within the given timeframe. However, this is not only up to the notified bodies.
This whitepaper discusses why the new transitional periods were necessary and the consequences that notified bodies expect from this change. Furthermore, this paper elaborates on the current status quo of notified body capacity and measures that will help to secure a successful transition.