Latest other devices regulatory guidance
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18 Oct 2006 | Optical Flyer - The Application of the EC Medical Devices Directive to Ophthalmic Medical Practitioners, Optometrists, Dispensing Opticians and Manufacturing Opticians
(168Kb)
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02 Dec 2005 | Medical device appeals
This document outlines the various means of appeal in the Consumer Protection Act 1987, Medical Devices Regulations 2002, General Product Safety Regulations 2005 and appeals conducted administratively by MHRA against various regulatory decisions concerning medical devices.
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19 Jul 2004 | Post-market Surveillance of CE Marked Joint Replacement Implants including Guidance to Manufacturers on Post-Market Clinical Studies
(83Kb)
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08 May 2003 | The In Vitro Diagnostic Medical Devices Directive - Background Note
The In Vitro Diagnostic Medical Devices Directive (98/79/EC) was formally adopted at the General Affairs Council of Ministers on 5th October 1998 and was published in the Official Journal of European Communities on 7th December 1998 (ref L331/1).
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05 Aug 2002 | Amended proposal for a Directive of the European Parliament and of the Council amending Council Directive 93/42/EEC, as amended by Directive 2000/70/EC, concerning medical devices
Amended proposal for a Directive of the European Parliament and of the Council amending Council Directive 93/42/EEC, as amended by Directive 2000/70/EC, concerning medical devices, as regards medical devices incorporating stable derivatives of human blood or human plasma.
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02 Aug 2002 | Changes to the Registration of Medical Devices
Please note the following changes to the registration of medical devices under Article 14 of Directive 93/42/EEC as implemented by Regulation 19 and 53 and 60 of the Medical Devices Regulation 2002 (SI 2002 No 618).
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02 Aug 2002 | Notifications by Manufacturers or Authorised Representatives who are not based in the UK
Until the European Databank referred to in Article 12 of Directive 98/79/EC on in vitro diagnostic medical devices ('the Directive') has been established, manufacturers or Authorised Representatives who are not based in the UK and who place IVDs on the UK market are required to provide the same information to the Competent Authority (UK) as those who are based in the UK.
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02 Jul 2002 | Enforcement Policy - Compliance Inspection and Action - Your Rights
MHRA Enforcement Responsibilities
