UK Based Medical Device Manufacturers

After the UK formally left the EU (BREXIT) on 31st December 2020, the UK ceased to be recognised as a full EU member state by the remaining EU members.

Therefore, to comply with the EU Directives / Regulations for CE Marking, a UK device manufacturer must designate an Authorised Representative (AR) based within a full EU member state, to register their devices with their local Competent Authority. We have an office within the EU in Cork, Ireland who can act as your AR, registering your company and devices with the Irish Competent Authority (HPRA).

Non-EU Based Medical Device Manufacturers

All non-EU medical device manufacturers must have an AR based in a full EU member state, if they also sell their devices into the EU.

SGB Consulting Services' associate company based within Europe in Cork, Ireland (European Healthcare & Device Solutions Ltd.) are able to support non-EU device manufacturers with registration with the Competent Authorities in Ireland (HPRA), thus fully complying with the EU post-Brexit requirements.

What does an EU Authorised Representative do for your business?

• An AR will act as a liaison between your business and the relevant competent authorities
• They will be Identified upon product labelling for European market
• Help with device registrations
• Provide copies of Technical Files and Declarations of Conformity to Competent Authorities upon request
• Support with adverse incidents and Field Safety Corrective Actions working with both you and your distribution network.

Benefits of using our EU Authorised Representative service

We currently provide this service to many medical device clients globally so you can be assured of our support and expertise.

We can represent your medical or in-vitro device, evaluate Technical Files and respond directly to Competent Authorities regarding any queries.