The UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) has issued the second edition of the Guidance for Virtual Manufacturers.
Please note that this is the official opinion of only one competent authority, soon to exit the European Union, and should therefore not be considered as the opinion of all notified bodies or competent authorities. Despite being a single opinion of a competent authority leaving the EU, we have heard similar opinions from a notified body as well as from a single member state medical technology association. Nevertheless, today it is still unclear what the formal opinion will be of all notified bodies and competent authorities on the subject of virtual manufacturing.
MHRA has replaced the term “Own Brand Labelling” (OBL) by “Virtual Manufacturer” and requires that all virtual manufacturers must hold the full technical documentation for any product they place on the market under their name.
This requirement may cause dilemmas in terms of intellectual property and proprietary information related to device design. When a virtual manufacturer does not own or hold the rights for product design, notified bodies and competent authorities may accept technical files with redacted proprietary information, according to the guidance. Redactions should be as limited as possible. Full redaction of all formulas, ingredients, algorithms or manufacturing processes will not be accepted and where redactions are made a justification is to be provided by the “Original Equipment Manufacturer” (OEM).
When a virtual manufacturer holds redacted technical documentation, they must have contractual arrangements in place allowing full disclosure of such information by the OEM to the virtual manufacturer’s notified body without the need of additional agreements to be made between the OEM and the notified body.
A virtual manufacturer may be considered a distributor, and not the manufacturer, in a number of specific cases. This role must be backed by a signed agreement with the manufacturer and the legal manufacturer must be clearly identified with name and address on the packaging and labelling of the device.
What does this mean to you?
If you place products on the market as a virtual manufacturer you must set-up an agreement with the OEM to ensure you hold the full technical documentation. If your OEM does not want to disclose all proprietary information, and thus provides a redacted version of the technical documentation, you must ensure that you:
- hold the documented justification for each piece of redacted information;
- have a contract in place with your OEM with regards to the full disclosure of the proprietary information to the virtual manufacturer’s notified body should they request this.
Changing your role from manufacturer to distributor could also be a means to overcome the intellectual property dilemma.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.