EU MDR News!! (MDR Timelines)
With the adoption of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), the regulatory framework for medical devices and in vitro diagnostic medical devices (IVD) has changed significantly. The main objectives of these two regulations are to
“establish a robust, transparent, predictable and sustainable regulatory framework for medical devices and in vitro diagnostic medical devices which ensures a high level of safety and health whilst supporting innovation”.
Five years have passed since their adoption and the system is being implemented including the development of the joint assessment process for designation of notified bodies, designation of expert panels, publication of harmonised standards as well a large number of guidance documents seeking to help economic operators to comply with their obligations under the Regulations.
Data provided in April 2022 by notified bodies show that more than 90% of currently valid AIMDD/MDD certificates will expire in 2023-20241. To date, 30 notified bodies are designated under the MDR, managing around 80% of current AIMDD/MDD
While the MDR has been applicable since 26 May 2021, it provides for transitional provisions allowing medical devices certified under the AIMDD and MDD to be placed on the market until the expiry date of relevant certificates and no later than 26 May 2024. The transition period intends to give further time to the system to prepare and to get ready, for example time for manufacturers to prepare their quality management system (QMS) and technical documentation before applying to a notified body. This step should not be perceived as a “grace period” to postpone the entering into application of the new rules. At this stage, data collected by notified bodies, and presented to competent authorities in December 2021, shows that nearly 37% of
manufacturers’ applications have been refused on the basis of incomplete applications, underlining an overall lack of manufacturers’ preparedness.
In April 2022, 75% of notified bodies indicated that more than 50% of the submitted applications were deemed incomplete.
From 27 May 2024, the MDR will be fully applicable to all medical devices. Manufacturers are responsible to ensure that their devices comply with the MDR as from the end of the transition period. From that date, medical devices not certified
under the MDR will have no access to the EU market.
It should be noted that around 70% of AIMDD/MDD certificates will expire in 20245 (by 26 May 2024 at the latest). Manufacturers should take into consideration that it might not be possible that notified bodies designated under the MDR would be able
to assess all corresponding files within the first months of 2024