Why do Manufacturers require a European Authorised Representative?
Legal background
Regulation 2019/1020 requires international manufacturers of medical devices (MDs) and in-vitro diagnostic devices (IVDs) who market their products in the EU to appoint a EU-based Authorised Representative. The purpose of this appointment is to ensure product compliance and to provide a point of contact for authorities.
Non-compliance with EU medical device regulations can lead to serious consequences:
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- Products may be barred from entering or remaining on the EU market
- Regulatory authorities may impose substantial fines
- Non-compliant devices risk being confiscated and product recalls
- Public non-compliance notices may be issued damaging brand reputation and eroding consumer trust
Our services
The Solutions we offer as your EU Authorised Representative
Ensuring full regulatory compliance is not just a legal obligation, it’s essential to establishing your business and reputation in the European market. Partner with us to allocate an official point of contact for EU authorities who keeps all your technical documentation organised and inspection-ready. From guiding you through the CE marking process to verifying your device labels meet strict EU standards, we help streamline your path to market access. Our team also registers your products in the mandatory EUDAMED database, monitors post-market performance, and manages safety incident reporting and notifications, all so you can operate with confidence and peace of mind in the European market.
