06/11/2024

Medical Devices in the European Union (EU) are regulated by the Medical Device Regulation (MDR) (Regulation EU 2017/745) which supersedes the previous Medical Devices Directive (MDD)( 93/42/EEC). MDR was implemented on May 26th, 2021 with a three-year transition period. MDR requires that all manufacturers of medium to high-risk medical devices be certified by a notified body. Notified bodies are independent, third party, and often private, for-profit groups designated and monitored by Member States that perform MDR conformity assessments for medical device manufacturers. The formation of for profit notified bodies is market driven, and since the requirement for their certification is recent, there are very few relative to the number of manufacturers needing assessments. In response to the shortage of notified bodies, in January 2023 the European Commission (EC) proposed a further extension for certain medical devices which the European Parliament voted to adopt in February 2023. To mitigate a potential shortage, medical devices marketed before the end of the transition period (‘Legacy Devices’) that were in compliance with all MDD regulations could be granted this timeframe for recertification extension. If granted, low to medium risk legacy devices (Class IIb MDs not included in high risk, Class IIa, Class Im, Is, and Ir) will be given an extension until December 31st, 2028 and high risk medical devices (Class III and certain implantable Class IIb) will be given until December 31st, 2027.

The three-year MDR transition deadline of May 26, 2024 was also the deadline for manufacturers to apply for their medical devices to be assessed for legacy status so they may benefit from the extended transition period (for more information on legacy device qualification, please click here).

To monitor the availability of medical devices on the market, the EC commissioned a study starting on December 2nd, 2022 for a duration of 36-months (ending December 1st, 2025). The study was designed to examine the implementation of MDR from the perspective of key stakeholders in order to identify any potential disruptions to the supply of medical devices on the market. The study team contacted every active notified body working on MDR assessments and asked them a series of questions pertaining to medical device conformity assessments at various frequencies (every 2 months, 4 months, yearly). The questions included:

How many manufacturers were applying for certification
How many certifications were issued within a specified timeframe
How long the certification process takes

The results so far have shown the number of applications for assessments far exceeds the number of certificates being issued, with a majority of cases taking under two months to complete an assessment. For more information on the study as well as all of the current updates, please click here.

To read more on the timeline of the MDR implication and supplementary information about MDR please see our previous blog entries on the topic.

MDR Delay Due to COVID-19 Pandemic

Medical Device Regulation Transition Extension Proposal

Medical Device Regulation Transition Extension Adopted

Delay in Medical Device Certification due to European Council Adopting Regulation

-The Clinical Pathways Team

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