The UK Medical Device Regulations mean that the MEDDEVS guidance documents are now considered by MHRA to be mandatory requirements to demonstrate compliance with the Medical Devices Directive to meet regulatory requirements. Most Notified Bodies in the UK are already requiring full compliance with the relevant MEDDEVs.

The UK medical device regulations are based on SI.2002-618 this meets both the requirements of the EU Medical Devices Directive 93/42/EC and the new EU Medical Device regulations 2017-745.

If you are only supplying to the UK you do not currently have to upgrade to 2017-745

Quality Standard BS EN ISO 13485:2016 . This is fully acceptable for regulatory purposes but needs to refer to the local regulations also. For CMDCAS approval under MDSAP this also requires certification to ISO 13485:2016

The New EU medical devices regulations 2107-45 come into effect from May 2021 and for IVDs come into effect in May 2022. At this time the new EU EUDAMED database should be operational for all manufacturers, Authorised representatives, and Importers will need to record the products they manufacture or handle.

Distributors to the EU may need to record their details with their regional regulatory Authority in the EU.