Appendix 2 - Medical device legal framework with respect to Brexit
Medical Device Regulation
- The updated EU Medical Devices Regulation (EU-MDR) will NOT be passed into law in Great Britain
- Instead, the Medical Device Regulation (UK -MDR) 2002 remains in place.
- The exception within the UK is Northern Ireland. Northern Ireland has ‘special status’ and EU Rules will continue to apply.
- So: Manufacturers intending to sell equipment in Great Britain need to comply with the older 2002 regulation.
CE marking
- The UK will continue to recognise the EU CE mark until June 2023
- From July 2023 all medical devices must be provided with a UK Conformity Assessment (UKCA mark)
- The EU will not recognise the UKCA mark.
- Manufacturers will have to apply to conform with both
- In addition to UKCA marking, non-UK based manufacturers will need to appoint a UK Responsible Person as the MHRA will only accept applications from UK based companies or UK based responsible Persons.
UDI – Unique Device Identification
- Currently no mandated requirement.
- Is mentioned in US regulations
- Currently under development in EU
In-House Manufacturing
- Medical Device Directive 2002 applies
- Healthcare exception remains in place allowing local manufacture for use by the same legal entity.
- Current UK guidance only recommends that a formal Quality Management System (QMS) should be in pace. This is expected to tighten in coming years. Good governance would suggest that a formal QMS incorporating the same controls expected from a commercial device manufacturer should be utilised.
- Specific NHS Scotland guidance is included in SHTN-00-04, stating that Manufacturers of custom-made devices shall have a formal QMS in place
