Challenge

Following the EC Recommendation 2013/473/EU, the Medicines and Healthcare Products Regulatory Agency (MHRA) replaced the term “Own Brand Labelling” (OBL) to “Virtual Manufacturer” for companies who do not design or manufacture the devices that they place their names on as “manufacturer”.  Guidance was also issued on the expectation of a “Virtual Manufacturer” in line with the EC recommendation.

The new guidance placed a significant burden on applicable manufacturers:

  1. The requirement to have their own Quality Management System (QMS)
  2. The need to have full technical documentation rather than “Summary Technical Documentation” or STED

​Approach

EUDRAC was very involved in supporting one of its clients to make these changes:

QMS

  • The EUDRAC Medical Device Team organised a complete review of the client’s QMS in order to establish the changes that were required for it to encompass their OBL medical devices; this required liaison with actual manufacturers and suppliers in order to understand their QMS and how to integrate the relevant elements within the client’s QMS.
  • We then assisted the client to write and implement new procedures and update others so that their QMS was now also applicable to the OBL devices.

Technical File

  • The STEDs for the OBL medical devices had to largely rewritten in order to include all the required information; this included some encouragement of the subcontractors to provide the information and, for some documents, translations were required.

Notified Body Audit

  • The Medical Device team was available during the subsequent audit by the Notified Body to provide further documentation and respond to questions; the outcome was very positive with only a few follow-up actions required.

Conclusion

We ensured a prompt response to the few outstanding items listed in the Audit Report; most issues had been resolved during the audit and it was closed very quickly.