MedTech Europe: The implementation of the new MDR and IVDR regulations is making slow progress
According to the European trade association representing the medical technology industries, MedTech Europe, the implementation of the EU regulations on Medical Devices (MDR) and In Vitro Diagnostic Medical Devices (IVDR) will be very challenging.
One of the challenges is that the notified bodies must be (re-)designated according to the stricter requirements of the new EU regulations. The designation process will take approx. 18 months for each individual notified body.
The notified bodies cannot approve new CE marking before the process is complete. At the same time, many new and existing products will have to be (re-)certified pursuant to the new rules, and for the MD products and the IVD products the deadlines are 26 May 2020 and 26 May 2022, respectively.
This is a tight deadline and entails a heavy workload for the notified bodies. If they cannot manage it in time, it may entail that access to new medical devices is delayed or that the marketing of medical devices needing re-certification will be stopped.
MedTech Europe has publicized an infographic providing a good overview of the challenges facing the notified bodies as well as a position paper, in which the trade association expresses great concern in relation to the implementation of the new regulations.