On March 20, 2023, the EU regulation extending the MDR transitional period came into force. The rationale for the regulation highlights that despite the increase in the number of designated notified bodies, their capacity is still insufficient to assess the conformity of devices with expiring MDD certificates. Moreover, a significant number of manufacturers—especially small and medium-sized enterprises—are not adequately prepared to demonstrate compliance with MDR requirements. This situation raises the risk of medical device shortages, justifying the extension of the transitional period.

What has changed?

• The validity of MDD certificates has been extended under certain conditions. The most important condition is that for MDD certificates expiring after March 20, 2023, the manufacturer must submit a formal application to a notified body by May 26, 2024, and sign a contract with the body by September 26, 2024.

• The deadline for further distribution of devices manufactured under the MDD (which was previously May 26, 2025) has been removed. This means that any device lawfully placed on the market under the MDD before May 26, 2021, or during the transitional period can be further distributed or put into service without any time limit.

What has NOT changed? The requirements for devices, the quality management system, and the conformity assessment procedures have not changed. Therefore, the workload, complexity, and cost for manufacturers remain unchanged. Moreover, an MDR-compliant quality management system must be implemented by May 26, 2024.

Written by: Attila Juhász (Professional Lead, SAASCO Ltd.)