The term "European Authorised Representative" can be used to refer to a EUAR, EC REP, CE REP, EU REP, and even an EAR. All of them refer to the same thing; the EU Authorised Representative.
It is your European Authorised Representative (EC Rep) who serves as an interface between you (the non-European manufacturer of medical devices) your national Competent Authorities (Ministry of Health) and Notified Bodies.
As an EC Rep i3cglobal will:
Perform your business in accordance with MEDDEV 2.5/10 Guidelines for Authorized Representatives
Make sure that the device is registered through the nation's Competent Authority (the MHRA in the UK or the MCCAA in Malta).
If asked, you must provide an uninvolved review of regulatory requirements of your design and labelling of the product.
Keep the complete technical documentation to be inspected by EU regulators upon request.
Aid in vigilance as well as Field Safety Corrective Actions (FSCA) reporting in conformity to MEDDEV 2.12/1 Revision 8
Updates and news on regulatory issues by way of our free monthly newsletter to clients.
The name and contact details of your authorized representative should be listed on the label, outside packaging, or instructions to usage (IFU). Also, you must utilize your EC Rep symbol, as defined in EN ISO 15223-1:2016.
In the current MDR (EU) 2017/745, Authorised Reps (EC Rep) are more accountable and assume significantly greater risks and liabilities, which means you are able to expect your representative to review your documents more carefully.
For more information, please contact the i3cglobal team:
Telephone: 7581471399
Email: enquiry@i3cglobal.uk
Website: https://www.i3cglobal.uk/eu-authorised-representative/
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What is the role of an EU Authorized Representative (EC Rep)?
Non-FictionThe European Authorised Representative acts as a legal entity, that is designated by manufacturers that are not European Union manufacturers to represent them within the EU and to ensure conformity with European Directives.
