Eurofins Expert Services Oy of Finland is the latest European Notified Body designated under the Medical Devices Regulation (EU) 2017/745 (MDR), before the Date of Application (DOA) 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.
EU notified body designation pipeline points to IVDR bottleneck
The European Commission has revealed minimal progress in the pipeline of notified bodies seeking designation against the incoming In Vitro Diagnostic Regulation (IVDR).
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 the delisting of BSI Assurance UK Ltd. in the wake of a no-deal Brexit.
The update from the Commission sheds light on the number of notified bodies that are likely to be in a position to receive submissions to certify products under IVDR by early next year. The Commission had added four notified bodies to its NANDO database. A fifth notified body has received the recommendation of the Medical Device Coordination Group (MDCG) but is yet to be designated.
The composition of the pipeline suggests that at some point the shortfall of notified bodies will abate. More than two-thirds of notified bodies designated under the outgoing IVD directive have applied to be designated under IVDR. The problem is around half of the applicants are yet to advance beyond the first few steps in the designation process. 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)
Here we show you the list of Notified Bodies that currently have received their designation under 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)