Drug Regulator, MHRA, Publishes an Updated Guide for Manufactures on Clinical Investigations to be Carried out in the UK
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The Medical Devices Regulations 2002 (SI No 618), as amended by the Medical Devices (Amendment) Regulations 2008, came into force on 13 June 2002 and implement the provisions of the Medical Devices Directive 93/42/EEC (as amended by Directive 2007/47/EC), the Active Implantable Medical Devices Directive 90/385/EEC (as amended by Directive 2007/47/EC) and the In Vitro Diagnostic Medical Devices Directive 98/79/EEC. These Regulations establish systems under which a manufacturer must submit to the UK Competent Authority, information about clinical investigations of medical devices to be carried out in the UK.
These Notes outline the legal requirements relating to the conduct and performance of a clinical investigation as set out in these Regulations. They also provide background and guidance to manufacturers on how to apply for pre-clinical assessment of a proposed clinical investigation in human subjects, involving a device falling within the scope of the Regulations.
Manufacturers wishing to make an application for pre-clinical assessment of a proposed clinical investigation of an active implantable medical device or a medical device to be carried out in part or in whole in the UK should apply to the Medicines & Healthcare products Regulatory Agency of the Department of Health (referred to in this document as the UK Competent Authority), in accordance with these Guidance Notes.
This guidance is intended as a general explanation of the legislation and should not be regarded as an authoritative statement of the law nor as having any legal consequence. It follows that manufacturers and others should not rely solely on this guidance but should consult the legislation referred to and make their own decisions on matters affecting them in conjunction with their lawyers and other professional advisers. The MHRA does not accept liability for any errors, omissions or other statements in the
guidance whether negligent or otherwise. An authoritative statement could be given only by the courts. Information and assistance in individual cases may be sought from the UK Competent Authority whose address and telephone number are given on pages 12 – 13 of this document.
