Banner%202_edited.jpg

UK responsible person and eu authorised representative

Banner 2.png

Medical device manufacturers based outside of the UK requires 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 off the EU requires an EU based authorised representative to sell devices in the EU. Psephos offers EU Authorised Rep service for all device manufacturers who want to sell medical devices in the EU.


Psephos can be both your UK Responsible Person and EU Authorised Representative. With offices based in Brighton, UK and Galway, Ireland. More information can be found in our article '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 an 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 an UK based Responsible Person
     

  2. Appoint and 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

Typing
On the Phone
Abstract Structure
Businessmen

Find us on LinkedIn & Twitter