European Parliament Passed Proposal to Extend MDD

European Parliament Passed Proposal to Extend MDD

On February 16, 2023, the European Parliament voted by a majority to extend the validity of MDDs for high-risk devices and medium-risk and low-risk devices until May 2027 and May 2028, respectively. Officially, the resolution will become effective upon publication in the Official Journal of the European Union.

The deadline extension is contingent upon the current MDD certified company completing a formal MDR application to N.B. by May 26, 2024, and completing the contract stipulated in MDR Annex VII section 4.3 with N.B. by September 26, 2024.

While DQS is still accepting new MDR applications, we believe that this decision will hasten the filing of MDR applications with N.B. by 2024 for products that have not yet filed MDR applications, which account for 70% of all MDD-acquired products. In addition, even for products that have already obtained MDD, obtaining MDR is a prerequisite for making design changes, so N.B. resources will continue to be in short supply during the transition period.

Background of this Decision

The European Commission is concerned that the transition from MDD to MDR has been significantly delayed due to the impact of the COVID-19 pandemic on the global supply chain, Russia's war of aggression against Ukraine, and other factors, and that the end of the transition period in May 2024, the default date, will result in a shortage of medical devices in the EU market. We are concerned that the transition period will expire in May 2024, the default date.

Expiration Date Number of MDD (IVMD) certificates to expire
1,139 in 2021
2,370 in 2022
4,311 in 2023
17,095 in May 2024
*Source: EU official web site

According to information from N.B., 1,990 certifications were issued out of 8,120 applications as of October 2022.
The total number of certifications by May 2024 is expected to be around 7,000, which is less than 30% of the total 23,776 MDD certifications that will expire between 2022 and 2024.
Extension of MDD certificates issued by May 26, 2021
Class IIa & Class I Extension until December 31, 2028
Class III & Class IIb Extension until December 31, 2027
Class III implantable custom made devices devices Extended through December 31, 2026