Local Authorized Representative

Whenever you think of marketing your product in a new market like EU, USA or global markets, if your company does not have a physical location, then you need an Authorized Representative who serves as a liaison between you and the National Health Authorities to comply to the Directives and Regulations. It is possible to nominate a distributor as your Authorized Representative; however, it is not advisable as most distributors are not equipped to execute the mandatory responsibilities of the Authorized Representative. To separate your commercial and regulatory interests, it is not a good idea to appoint a distributor as your Local Authorized Representative

REGULATING MEDICAL DEVICES IN THE POST BREXIT EUROPEAN UNION

Brexit has significantly impacted medical device manufacturers who want to market across the UK, particularly regarding in-country representation. After the UK left the EU on February 1, 2020, a transition period began and a new role as the UK Responsible Person has been created under the UK MDR 2002 (as amended by the UK MDR 2019), a UKRP is a must from January 1, 2021, and the UKRP must register the device manufacturer, any device importers, and the devices with the MHRA. MHRA plans to substitute the CE mark with a UK Conformity Assessment (UKCA) mark; its use is currently expected to become mandatory on June 30, 2023.

EU-based manufacturers selling their medical devices in the remaining 27 EUMember States will need a UK Responsible Person to market their medical devices in the UK. Non-EU manufacturers using EU-based Authorized Representative will require a UK Authorized Representative to market their devices in the UK. Non-EU manufacturers using a UK-based Authorized Representative (AR) will need to appoint a new EU-based Authorized Representative. UK-based manufacturers will become non-EU manufacturers, who will need to appoint an EU based Responsible Person if they want to place medical devices on the EU market.