Are you a non-European Manufacturer and need to export your Medical Device in Europe?
According to MDR (EU) 2017/745 and IVDR (EU) 2017/746 Regulations and starting from May 26, 2021 if your Company doesn’t have a physical location in Europe, you must appoint a European Authorised Representative.
An European Authorised Representative must be a physical or legal person established in one of the EU Countries, that is expressly designated by the Manufacturer and contact reference of the Competent national Authorities on behalf of the Manufacturer.
The EU Authorised Representative is legally liable for defective devices on the same basis as, and jointly and severally with, the Manufacturer in case the latter acts not in compliance with the obligations stated by the regulations (Art. 10). The EU Rep contact details appear on the device label and in Eudamed.
As your European Authorised Representative Thema can be in full compliance with articles 11 and 12 of the MDR/IVDR and assure the compliance of your devices to the regulations as Thema:
- has an ISO 13485:2016 certification including the EU Authorised Representative processes;
- executes an accurate pre-screening of the documentation in order to assess the conformity to EU regulations;
- has an adequate insurance policy in case of regulatory issues arising from the market;
- has appointed a Person Responsible of the Regulatory Compliance (PRRC) – art. 15 – as requested by MDR/IVDR to the EU Authorised Representative;
- assures the availability to cooperate with Competent Authorities and Manufacturer in case of recalls and field safety corrective actions;
- can help the Manufacturer registering in Eudamed and in the Member State national database.
Download the EU REP service document
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For more information and to request the European Authorised Representative service CONTACT US