A recent round of inspections by the Dutch Health and Youth Inspectorate (IGJ) has found that more than one-third of European Authorized Representatives (ARs) operating in the Netherlands have yet to meet all requirements applicable under the European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).
European Authorized Representatives under supervision
European ARs are the gateway to the European Union (EU) for non-EU based medical device and IVD manufacturers. As such it isn’t surprising that with the new Regulations, ARs must comply with stricter requirements, as well:
- ARs need to comply with legal requirements based on European legislation, such as the MDR and IVDR
- Competent Authorities (CAs) across the EU supervise ARs in the member states in which they’re based
- ARs are held legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturers they represent
The Dutch Health and Youth Care Inspectorate (IGJ) supervises ARs based in the Netherlands, and recently published a report on the outcome of the their inspections of 24 ARs based in the country. (Emergo by UL’s AR business, Emergo Europe B.V., is based in the Netherlands and was included in the report.)
What was inspected?
In the Netherlands alone, 347 ARs are registered in the Dutch Database, NOTIS. Picture 1 below shows the registered ARs and the number of devices they represent.
Dutch IGJ Report on EU AR Compliance to MDR, IVDR | Emergo by UL
Dutch Regulators Issue Report on AR Compliance with MDR, IVDR
A recent IGJ inspection report finds that one-third of European Authorized Representatives in the Netherlands have yet to fully follow MDR and IVDR requirements.
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