UK MHRA issues revised guidance for Manufacturers and Notified Bodies
MHRA has recently issued revised guidance dated March 2017. Own Brand Labeller (OBL) was the term used to describe an organization that places their own label/brand name and name and address on a device that they haven’t designed, don’t manufacture, and is already CE marked and on the market in the name of another company. In this recent guidance, MHRA indicates that it is replacing the term ‘Own Brand Labelling’ with ‘virtual manufacturing’.
Examples of own brand labelled products range from adhesive dressings branded for supermarkets to energy generators for minimally invasive surgical devices. The original equipment manufacturer (OEM) designs the product and manufacturers it, or has it manufactured. The virtual manufacturer is named on the label as the legal manufacturer when they affix the CE mark.
The updated guidance is based on part of Commission Recommendation 2013/473/EC. This wide-ranging decision clarified that the virtual manufacturer is indeed the manufacturer as defined in the medical devices and IVD Directives. This remains the interpretation under the forthcoming Regulations.
The MHRA guidance reinforces that the virtual manufacturer simply cannot refer to the quality management system (QMS) or the technical documentation held by the OEM, but should hold the full technical documentation which should be an output of their own QMS.
- Where the device requires notified body involvement, the notified body:
- audits the QMS of the virtual manufacturer; and
- reviews the full technical documentation held by the virtual manufacturer.
- If the device does not require notified body review, the virtual manufacturer:
- has full technical documentation available for Competent Authority review; and
- meets relevant registration requirements.
The guidance indicates that technical documentation of a virtual manufacturer can have redacted proprietary information if redactions are limited and redacted information is not essential for assessing whether the device complies with regulatory requirements.
Organizations that act as virtual manufacturers should work with their notified body to analyse the effect of this revised guidance on their conformity assessment strategy.
Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development.