Two months after being designated as the third Notified Body (NB) under the Medical Devices Regulation (MDR), the German company Dekra Certification GmbH was annouced last week by the European Commission (EC) as the first NB to be designated under the EU In Vitro Diagnostic Regulation (IVDR), with its official listing appearing in the NANDO database.
Nine other NBs are currently being evaluated in the IVDR sector and it is expected that they would be designated soon under the IVDR.
According to the industry group MedTech Europe, the EC is expecting to have a total of twenty NBs designated by the end of 2019.
Asphalion provides comprehensive support during development, validation, certification and manufacturing of Medical Devices in Europe.
If you need any support or have any further question, please contact us at [email protected]
