MDCG urges manufacturers to use MDR transition period wisely

Regulatory NewsRegulatory News
| 13 June 2022 | By Joanne S. Eglovitch 

The European Commission’s Medical Device Coordination Group (MDCG) on Monday said that manufacturers should start preparing now to ensure “timely compliance” with the Medical Device Regulations (MDR) by the time the regulation is fully applicable on 27 May 2024. Devices not certified by this date will no longer have access to the EU market, except in rare circumstances discussed in the notice.
 
MDCG reiterated that “to ensure that devices can continue to be placed on the market and to avoid shortages of medical devices it is essential that all manufactures adjust their systems, finalise transition to the MDR and apply to a notified body, submitting complete and compliant applications, as soon as possible and well in advance of the end of the transition period to ensure timely compliance with the MDR.”
 
MDR went into effect on 26 May 2021, and manufacturers were given time to transition the new regulation, with the transition period ending on 26 May 2024.
 
“This transition period intends to give further time to the system to prepare and to get ready, for example for manufacturers to prepare their quality management systems (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,” said MDCG.
 
Yet data still suggests that manufacturers may not be ready by the time the MDR compliance deadline, despite years of nudging by regulators and an expanding base of notified bodies designated under the new regulation.
 
Data collected by notified bodies 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.”
 
Information also suggests that notified bodies may be swarmed with applications at the last minute.
 
“Data provided in April 2022 by notified bodies show that more than 90% of currently valid AIMD/MDD certificates will expire in 2023. To date, 30 notified bodies are designated under the MDR, managing around 80% of current AIMD/MDD certificates.”
 
The guidance said derogation from the conformity assessment procedures under Article 59 of the MDR has been “mentioned as a possible remedy in case transition from AIMDD/MDD to MDR is not completed in time.”
 
Yet MDCG stressed that such derogations may be granted “only if the use of the device concerned is in the interest of public health, patient safety of patient health.” Further, “this mechanism should not be considered as a solution for cases of late application to a notified body for conformity assessment or delays in the conformity assessment procedures.”
 
An EU medical device official similarly urged medical device companies to get these systems up and running early, well ahead of the 2024 deadline at the RAPS Euro Convergence meeting last year. (RELATED: Euro Convergence: Experts advise on ways to manage the MDR grace period, Regulatory Focus 10 May 2021).
 
MDCG guidance on MDR

 

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