Authorised Representative in EU and UK

For manufacturers of medical devices outside the EU, it is crucial to understand and comply with the regulatory framework of the EU market. To access this important market, they must appoint an EU authorised representative as EC-REP. This position is not only essential for CE compliance, but also acts as a bridge between the manufacturer and the EU authorities. The EC-REP has a great deal of responsibility and must ensure that their tasks are clear and that communication is transparent.

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