Directives Bulletins

For guidance about individual publications, please contact: European & Regulatory Affairs

Medicines and Healthcare products Regulatory Agency
5 Magenta
151 Buckingham Palace Road
Victoria
London
SW1W 9SZ

Tel: 020 3080 7300

Email: era@mhra.gsi.gov.uk

A 24 hour message service for obtaining copies of bulletins is also available, please ring and leave a message on 020 3080 7203.

Latest directives bulletins

• 09 Jun 2011 | Directives Bulletin 10 - The Classification Rules  (70Kb)
  

• 27 Aug 2009 | Directives Bulletin 17 - Medical Devices and Medicinal Products  (131Kb)
  

• 12 Sep 2008 | Directives Bulletin 3 - Guidance on the operation of the EU vigilance system in the UK
  

  Guidance for manufacturers of medical devices (under review).

• 17 Mar 2008 | Directives Bulletin 4 - Conformity Assessment Procedures  (82Kb)
  

• 05 Oct 2007 | Directives Bulletin 2 - The CE Marking  (201Kb)
  

• 04 Mar 2006 | Directives Bulletin 21 - Application for the Exceptional use of non-complying devices (humanitarian bulletin)
  

  We have prepared guidance for clinicians and manufacturers to help clarify how, and under what circumstances they may make applications to the Competent Authority (MHRA) for the use of a non CE-marked device for an individual named patient in the interest of the protection of their health.

• 03 Mar 2006 | Directives Bulletin 12 - Sale and Supply of In Vitro Diagnostic Medical Devices (IVDs)  (122Kb)
  

• 03 Mar 2006 | Directives Bulletin 13 - Standards  (192Kb)
  

• 31 Jan 2006 | Directives Bulletin 20 - Conformity Assessment Procedures under the In Vitro Diagnostic Medical Devices Directive 98/79/EC  (79Kb)
  

• 31 Jan 2006 | Directives Bulletin 19 - Own Brand Labelling and Rented Products  (51Kb)