MHRA seeks feedback from medical devices industry about changes to Own Brand Labelling

Posted on 5 May 2016 (Permalink)

The Medicine and Healthcare products Regulatory Agency (MHRA) is seeking feedback from the medical devices industry about an important imminent change relating to Own Brand Labelling. 

There are two documents: 

The key section of the guidance document is on page 5, ‘Responsibilities of the own brand labeller’. What it means is that the Own Brand Labeller now needs to hold a full technical file; in effect, become the ‘manufacturer’. 

Some of the implications medical devices manufacturers need to consider: 

  • How these changes will affect their regulatory responsibilities and their approach to customers and markets 
  • Product manufacturers will need to consider making available copies of the full Master File to customers and the wider distribution of the confidential contents. 

Medical devices manufacturers are requested to disseminate this information and respond by Friday 13 May to