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UK responsible person/  

eu authoriseD representative

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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

  1. Appoint an EU Authorised Representative
     

  2. Appoint EU-based Notified Body required for all devices above Class I
     

  3. Obtain CE marking under the MDR or IVDR (May 2022)
     

  4. Ensure labelling updated to reflect EU Authorised Representative

#2 if you are a

EU Device Manufacturer wanting to sell to Great Britain

  1. Appoint a UK-based Responsible Person
     

  2. UK-based Responsible Person registers all devices (Class I to III) with MHRA
     

  3. Appoint UK-based Approved Body for all devices above Class I
    (from June 2023)

     

  4. Obtain UKCA mark
     

  5. Ensure labelling updated to reflect UK Responsible Person

#3 if you are a

Device manufacture outside of UK and EU

  1. Appoint a UK-based Responsible Person
     

  2. Appoint an EU-based Authorised Representative
     

  3. UK-based Responsible Person registers all devices (Class I to III) with MHRA
     

  4. Appoint EU-based Notified Body required for all devices above Class I
     

  5. Appoint UK-based Approved Body for all devices above Class I (from June 2023)
     

  6. Obtain UKCA mark
     

  7. Obtain CE marking under the MDR or IVDR (May 2022)
     

  8. Ensure labelling updated to reflect UK Responsible Person
     

  9. Ensure labelling updated to reflect EU Authorised Representative

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