Arazy Group

Medes Limited – EU: CE Authorized Representative – Arazy Group

If you want to know more about regulatory issues of Medical Devices, click here.

All Non-European manufacturers of medical equipment who wish to market their products in the EU market under their own name must designate a Regulatory Authorized Representative in order to meet CE requirements.

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What are the Responsibilities of the European Authorized Representative

The responsibilities of the Authorized Representative are:

Assisting European Authorities in communications with foreign establishments
Assisting European Authorities in scheduling inspections of the foreign establishment
Handel reports concerning vigilante activities or recall of products
On top of these Authorized Representative services we can also provide consulting services for writing or reviewing as well as maintaining Technical Files

References for the need to appoint a Regulatory Authorized Representative

The European Medical Device Directive 93/42 EEC Article 14
The European IVDD Directive 98/79EC Article 10.