Devices regulatory guidance

MHRA also provides more detailed guidance on the process that manufacturers should follow to meet the requirements of Medical Devices Directives in their Guidance Notes and Forms.

In line with the requirements of the Hampton Report on Reducing Administrative Burdens - Effective Inspections and Enforcement, MHRA keeps its guidance documents under constant review. If you have any feedback, particularly on the presentation, accessibility or clarity of any of our guidance notes or bulletins please inform the contact person indicated at the end of the individual document.

Latest devices regulatory guidance

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

• 04 Aug 2010 | Guidance Note 1 - Guidance Notes for Manufacturers on Clinical Investigations to be carried out in the UK  (741Kb)
  

• 05 Jul 2010 | Cardiac ablation catheters - guidance on the vigilance system (VG09)
  

  This document gives advice to manufacturers on the notification of adverse incidents involving cardiac ablation catheters under the medical devices vigilance system.

• 08 Dec 2009 | Neurostimulators - guidance on the vigilance system (VG08)
  

  This document gives advice to manufacturers on the notification of adverse incidents involving neurostimulators under the medical devices vigilance system.

• 23 Oct 2009 | Breast implants - guidance on the vigilance system (VG03)
  

  This document gives advice to manufacturers on the notification of adverse incidents involving CE marked devices under the medical devices vigilance system.

• 18 Sep 2009 | Guidance note 20 – Borderlines with medical devices  (108Kb)
  

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

• 27 Jul 2009 | Guidance Note 3 - Information for clinical investigators  (67Kb)
  

• 05 Jun 2009 | Intraocular lenses - guidance on the vigilance system (VG07)
  

  This guidance document provides advice to manufacturers on the notification of adverse incidents involving intraocular lenses (IOLs) under the medical devices vigilance system.

• 18 Mar 2009 | Coronary stents - guidance on the vigilance system (VG04)
  

  Advice for manufacturers on the notification of adverse incidents involving CE marked devices under the medical device vigilance system.