03 February 2021
The MHRA has published an updated version of its guidance for Virtual Manufacturing of medical devices.
The guidance, which was last revised in April 2019, has been updated to bring the document in line with the UK Medical Devices Regulations following the end of the Brexit Transition Period.
The updated guidance confirms that Virtual Manufacturing under the new UK regulations will continue to operate as had been the case under European legislation pre-Brexit. The guidance sets out:
- What has changed in the new version of the guidance
- What is a virtual manufacturer
- Responsibilities of a virtual manufacturer
- The technical documentation a virtual manufacturer needs
- What the contractual agreement between both parties should cover as a minimum
- What options a virtual manufacturer has if their OEM loses their UKCA/CE/CE UKNI certificate
- How disputes with UK Approved Bodies/EU Notified Bodies should be handled
- If a virtual manufacturer wants to change from being the legal manufacturer to the importer/distributor
The guidance notes that, in relation to importer/distributor status, different requirements will apply in Northern Ireland due to the application of the EU MDR.