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
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.
As your Local and Authorized Representative, we act as a link between you and the health Authorities and notified bodies. As an independent organization, MakroCare can act as your regulatory guide and Authorized Representative to assist you to:
MakroCare developed this service over many years to specifically support the needs of small and medium-sized manufacturers.
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