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UK Responsible Person for IVDs and Medical Devices

Aug 09, 2019

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

We are proud to be BIVDA Associate Members

IVDeology Ltd Proud To Be BIVDA Associate Members