UK responsible person/
eu authoriseD representative
Medical device manufacturers based outside of the UK require a UK-based Responsible Person to sell devices in the UK. Psephos offers a UK Responsible Person service for all device manufacturers who want to sell medical devices in the UK.
Medical device manufacturers based outside of the EU require an EU-based Authorised Representative to sell devices in the EU. Psephos offers a EU Authorised Representative service for all device manufacturers who want to sell medical devices in the EU.
Psephos can be your UK Responsible Person and/or EU Authorised Representative, with offices based in Brighton, UK and Galway, Ireland. Further guidance can be found in our brochure 'Brexit and UKCA Marking'.
#1 if you are a
UK Device Manufacturer wanting to sell to the EU
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Appoint an EU Authorised Representative
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Appoint EU-based Notified Body required for all devices above Class I
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Obtain CE marking under the MDR or IVDR (May 2022)
-
Ensure labelling updated to reflect EU Authorised Representative
#2 if you are a
EU Device Manufacturer wanting to sell to Great Britain
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Appoint a UK-based Responsible Person
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UK-based Responsible Person registers all devices (Class I to III) with MHRA
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Appoint UK-based Approved Body for all devices above Class I
(from June 2023)
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Obtain UKCA mark
-
Ensure labelling updated to reflect UK Responsible Person
#3 if you are a
Device manufacture outside of UK and EU
-
Appoint a UK-based Responsible Person
-
Appoint an EU-based Authorised Representative
-
UK-based Responsible Person registers all devices (Class I to III) with MHRA
-
Appoint EU-based Notified Body required for all devices above Class I
-
Appoint UK-based Approved Body for all devices above Class I (from June 2023)
-
Obtain UKCA mark
-
Obtain CE marking under the MDR or IVDR (May 2022)
-
Ensure labelling updated to reflect UK Responsible Person
-
Ensure labelling updated to reflect EU Authorised Representative
