Number 8: Dekra's Dutch NB Designated Under MDR

Regulatory NewsRegulatory News | 16 December 2019 |  By 

Dutch notified body (NB) Dekra Certification B.V. on Monday became the third Netherlands-based NB to be designated under the Medical Devices Regulation (MDR) and the eighth overall under MDR.

The designation means Dekra can review different types of active implantable and non-implantable devices, as well as non-active implants and non-active, non-implantable devices, among others.

Dekra said in a statement that it “firmly believes that the MDR designation further enhances its comprehensive range of product certification and quality management system assessments and will enable them to continue to be a reliable, competent partner for medical device customers, both now and in the future.”

And Dekra’s German-based outfit is also designated under MDR and is one of two NBs designated under the In Vitro Diagnostic Regulation (IVDR).

Meanwhile, EU Commissioner for Health Stella Kyriakides recently said that two more NBs are likely to be designated by the end of the year.

“I want you to know the [NB] designation process has been sped up and 12 designations have been completed and we hope that by the first quarter of 2020, we will get up to 20 designations,” Kyriakides said.

But experts noted that if these NB designation trends continue, the EU is still likely to face a lack of MDR certification capacity after Medical Device Directive certificates become invalid in May 2024. Here’s a look at the NBs designated so far:
  MDR designation? IVDR designation?
BSI Assurance UK Ltd Yes Yes
BSI Group The Netherlands BV Yes No
DARE!! Services BV Yes No
Dekra Certification BV Yes No
Dekra Certification GmbH Yes Yes
IMQ Istituto Italiano del Marchio di Qualita SPA Yes No
TÜV Rheinland LGA Products GmbH Yes No
TÜV SÜD Product Service GmbH Zertifizierstellen Yes No
Swiss NB QS Zürich AG, UL UK and London-based Lloyd's Register Quality Assurance have decided that they will not pursue designation under MDR or IVDR.


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