EC Names Eighth Notified Body for IVDR

The European Commission (EC) has named an additional Notified Body for the European Union (EU) In Vitro Diagnostic Regulation (IVDR). QMD Services GmbH is the eighth Notified Body designated under the IVDR. It has been listed in the NANDO database and assigned a Notified Body number of 2962.

Number of notified bodies under IVDR still considered low

According to Emergo by UL sources, the number of Notified Bodies available to perform conformity assessments is still considered low. To efficiently handle the expected volume, it has been suggested that at least 11 Notified Bodies be designated under the IVDR.

As we have previously reported, Team-NB, the European Association of Notified Bodies handling medical devices, published a position paper in November 2020 expressing skepticism that the low capacity of Notified Bodies would be sufficient to serve the European market.

QMD Services GmbH joins seven other notified bodies designated under the IVDR:

• 3EC International a.s., NB 2265
• BSI Group The Netherlands B.V., NB 2797
• DEKRA Certification B.V., NB 0344
• DEKRA Certification GmbH, NB 0124
• GMED SAS, NB 0459
• QMD Services GmbH, NB 2962
• TUV Rheinland LGA Products GmbH, NB 0197
• TUV SUD Product Service GmbH, NB 0123

Emergo by UL will post updates to the guidance as they become available.