20th Notified Body Designated Under EU MDR While IVDR Designations Lag

Eurofins Expert Services Oy of Finland is the latest European Notified Body designated under the Medical Devices Regulation (EU) 2017/745 (MDR), making it in shortly before the new regulatory scheme’s Date of Application on May 26, 2021. It has been listed in the NANDO database and assigned a Notified Body number of 0537. This brings the total number of Notified Bodies designated under MDR to 20. SGS Fimko Oy, also of Finland, received its designation earlier this year.

Progress on Notified Body designation continues to raise IVDR capacity concerns

There remain only four Notified Bodies designated under the EU In Vitro Diagnostic Devices Regulation 2017/746 (IVDR); the addition of TÜV Rheinland late last year was offset by the delisting of BSI Assurance UK Ltd. in the wake of a no-deal Brexit.

Team-NB, the European association of Notified Bodies handling medical devices, published a position paper in November 2020 expressing skepticism that the current IVDR Date of Application in May 2022 would be possible to implement given the expected low Notified Body capacity at that time. Since then, not much has changed: according to an overview released by the European Commission and updated in March 2021, only 16 applications have been received for IVDR designation, of which two have been withdrawn because they were UK entities. This does not constitute an improvement over the situation as it stood at the end of 2020. Only one Notified Body is shown to be in the final stages of the pipeline for IVDR designation, while eight are in the final stages for MDR. The low number of Notified Bodies likely to be designated by next year will likely lead to increasing discussion about the appropriateness of postponing the IVDR Date of Application.

Current lists of MDR- and IVDR-designated Notified Bodies

Below is an updated list of all the Notified Bodies currently designated under EU MDR:

• UDEM Adriatic d.o.o. (Croatia)
• GMED (France)
• Eurofins Expert Services Oy (Finland)
• SGS Fimko Oy (Finland)
• DEKRA Certification GmbH (Germany)
• DQS Medizinprodukte GmbH (Germany)
• MDC Medical Device Certification GmbH (Germany)
• MedCert Zertifizierungs- und Prüfungsgesellschaft für die Medizin GmbH (Germany)
• TÜV Rheinland LGA Products GmbH (Germany)
• TÜV SÜD Product Service GmbH Zertifizierstellen (Germany)
• CE Certiso Orvos (Hungary)
• National Standards Authority of Ireland (NSAI) (Ireland)
• IMQ (Instituto Italiano del Marchio di Qualita) S.P.A. (Italy)
• Istituto Superiore di Sanità (Italy)
• BSI Group The Netherlands B.V. (The Netherlands)
• DARE!! Services B.V. (The Netherlands)
• DEKRA Certification B.V. (The Netherlands)
• DNV Product Assurance AS (Norway)
• 3EC International a.s. (Slovakia)
• Intertek Medical Notified Body AB (Sweden)

The following Notified Bodies are designated under EU IVDR:

• DEKRA Certification GmbH (Germany)
• TÜV Rheinland LGA Products GmbH (Germany)
• TÜV SÜD Product Service GmbH Zertifizierstellen (Germany)
• BSI Group The Netherlands B.V. (The Netherlands)

Resources for EU MDR and IVDR compliance at Emergo by UL:

• European MDR preparation and compliance resource center
• European IVDR preparation and compliance resource center
• European Authorized Representative in-country representation
• Whitepaper: Extended MDR date of application—optimizing your PMS and clinical activities
• Webinar: Preparing for the EU MDR Date of Application
• Webinar: Applying human factors engineering to IVD products under IVDR