Virtual Manufacturing of Medical Devices
The Medicines & Healthcare Products Regulatory Agency (MHRA) has published a new guidance on "Virtual manufacturing of medical devices." This document replaces the previous edition "Own Brand Labeling".
The new document applies to manufacturers in conformity with:
- Medical Devices Directive (93/42/EEC)
- In Vitro Diagnostic Medical Devices Directive (98/79/EC)
- New Medical Device Regulations (2017/745)
- In Vitro Diagnostic Medical Device Regulations (2017/746).
What has changed?
In march 2017 “Own Brand Labelling ” has been changed into “virtual manufacturing”.
The UK previously accepted a summary of the technical documentation (STED) that had to be retained by the manufacturer and assessed by the notified body.
Now all virtual manufacturers must maintain complete technical documentation for each product they market under their name.
The document you can download below provides more information about:
- What is a virtual manufacturer?
- Responsibilities of a virtual manufacturer?
- What technical documentation does a virtual manufacturer need?
- What should the contractual agreement between both parties cover as a minimum?
- What options does a virtual manufacturer have if their OEM loses their CE certificate?
- How should disputes with UK Notified bodies be handled?
- If a virtual manufacturer wants to change from being the legal manufacturer to the distributor.