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]