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UK Responsible Person for IVDs and Medical Devices

73 days to go….

Are you ready for the 31st October 2019?

Under the circumstances of a no deal Brexit, where the UK will leave the EU without an approved withdrawal agreement. All IVDs and Medical Devices placed on the UK market by a non-UK manufacturer will require a local UK Responsible Person. Similar to the EU Authorised Representative the UK responsible person is required to be appointed by non-UK based manufacturers to act on their behalf. Their responsibilities include:

  • Device registration
  • Post Market Surveillance Activities
  • Recall and vigilance activity
  • Act as a point of contact to the UK Notified Body

IVDeology are pleased to offer a UK Responsible Person service using our extensive knowledge of the UK and EU quality requirements and regulation. 

For more information regarding this service please contact [email protected]