In December, The MHRA announced a change in the requirements for medical devices manufacturers known as “Own Brand Labellers” in a draft guidance. The final guidance has now been published.
This term “Own Brand Labellers” will no longer exists and be replaced by “Virtual Manufacturer”.
A virtual manufacturer places devices on the market under his name despite not undertaking the design and manufacture of the devices.
For devices other than Class I, the manufacturer must have a quality management system audited by a notified body, and hold a full technical file for a notified body review.
Class I virtual manufacturer must also have a full technical file for presentation to the Competent Authorities upon request.
In some cases related to proprietary information, notified bodies may accept redacted information from the original manufacturer (OEM). Examples of such information are : unique material formulae or ingredients, unique manufacturing process, technical drawing and technologies (when a patent is not yet granted), software algorithms.
A general contractual agreement must also be in place between the OEM and the virtual manufacturer. When proprietary redacted information are presented, a specific clause in the contractual agreement must ensure full disclosure of information from the OEM to the notified body of the virtual manufacturer.
These new requirements are applicable from 1st September 2017.
If the virtual manufacturer and the notified body don’t agree on regulatory requirements, they can contact the MHRA for clarification at email@example.com.
The complete MHRA guidance can be downloaded here.
If you are interested in own brand labelling issues and requirements, please consult our white paper on the subject here.