European Notified Body Survey: MDR, IVDR Certification Numbers Remain Low

A new survey from the European Commission shows that many medical device and in vitro diagnostic (IVD) manufacturers have yet to apply for certification under the Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR), despite pending expirations of their CE Marking under previous Directives.

Conducted by the European Commission’s Medical Device Coordination Group (MDCG), the survey examines Notified Body certification and application activities as the MDR and IVDR take effect. The MDCG has previously issued recommendations for medical device manufacturers to secure MDR compliance in order to avoid decertification and ultimately a potential device supply shortage in Europe, but the new survey results provide significant data highlighting compliance challenges.

MDR compliance challenges

The MDCG survey includes responses from 47 European Notified Bodies. Respondents report a total of 22,793 valid CE certifications under Medical Devices Directive 93/42/EEC (MDD) and Active Implantable Medical Devices Directive 90/385/EEC (AIMDD); about 17,000 of these certifications are set to expire in 2024, after which they will need to be renewed according to MDR requirements in order to remain on the European market.

However, Notified Bodies indicate that they have only received 8,120 applications for CE certification under the MDR as of October 2022. Furthermore, less than 2,000 CE Mark certifications have been issued under the MDR, illustrating backlogs in terms of assessment work facing Notified Bodies.

According to survey participants, MDR certification timelines for the most part take 13 to 18 months, or as long as 19 to 24 months in cases where certifications of both products and quality management systems are required.

IVDR certifications lagging

Regarding CE certification activities for IVD devices in the European Union, the MDCG survey notes a current total of 1,551 valid certificates issued according to In Vitro Diagnostic Medical Devices Directive 98/79 EC (IVDD) requirements. The majority of these certificates (866) will expire in 2025.

As of October 2022, only 822 applications for CE certification under the IVDR have been submitted to the Notified Bodies participating in the MDCG survey. In the context of new requisites that roughly 90% of self-certifying IVDs must involve Notified Bodies in order to establish IVDR compliance, the fact that only 268 IVDs have obtained certification under the IVDR indicates that a significant majority of manufacturers have a lot of work ahead of them in order to submit applications to Notified Bodies and secure certification by 2025.

Furthermore, of the 822 applications submitted to Notified Bodies, survey respondents report that nearly 50% of those submissions are incomplete, delaying conformity assessment processes.

In Emergo by UL’s experience, medical device and IVD manufacturers that have established relationships with Notified Bodies designated to issue CE certifications under the MDR and/or IVDR and that have carefully reviewed their applications internally or using third-party support may stand a better chance of avoiding delays ahead of aggressive European compliance deadlines.