UK Based Medical Device Manufacturers
After the UK has formally left the EU (BREXIT) on 31st December 2020, the UK will cease 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 in Cork, Ireland who can act as your AR, registering your company and devices with the Irish Competent Authority (HPRA).
Overseas Based Medical Device Manufacturers
Once the UK leaves the EU, all 'foreign' medical device manufacturers (i.e. non-EU Members) selling into the UK must identify / designate a Responsible Person (RP) based within the UK, to register their company and devices with the UK Competent Authority (i.e. MHRA), and to act on their behalf for UKCA related activities within the UK.
Furthermore, these same 'foreign' manufacturers must have an AR based in a full EU member state, if they also sell their devices into the EU.
In summary, if a 'foreign' device manufacturer sells their devices into the UK AND the EU, they will need joint / parallel registrations; one in the UK through a UK based Responsible Person, and a sec-ond with an AR based in a full EU member state.
SGB QA/RA Consulting Ltd. have an office in Somerset, UK, and our associate company based in Cork Ireland (European Healthcare & Device Solutions Ltd.). We are therefore able to support 'foreign' de-vice manufacturers with registration with the Competent Authorities in both the UK (MHRA) and Ire-land (HPRA), thus fully complying with the 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 or UK Responsible Person 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.
Please use ‘live chat’ or get in touch to discuss your requirements.