The Medicines and Healthcare products Regulatory Agency (MHRA) has published an update on their previous guidance for ‘virtual manufacturing’ of medical devices. The guidance is directed at manufacturers who do not design or manufacture devices, but have products branded in their name.
Key points of the guidance include:
- All virtual manufacturers are obliged to hold full technical documentation for any product they place on the market under their name
- This obligation remains regardless of any partial or total outsourcing of the production
- In the case of a virtual manufacturer not holding the rights related to product design then the virtual manufacturer should have in their possession a technical document with proprietary information redacted; redactions should be kept to a minimum
The guidance also includes regulations for the case of a virtual manufacturer wanting to change from being the legal manufacturer to the distributor.
MAP encourages MedTech companies that are affected to read the guidance in full. Documentation can be accessed here.