1.1 Legislation and Regulation
The regulation of medicinal products in the UK derives from EU legislation, principally Directive 2001/83/EC (the Directive), and Regulation (EC) 726/2004 (the EU Regulation). The key UK legislation is the Human Medicines Regulations 2012 (SI 2012/1916).
The Human Medicines Regulations define a medicinal product as follows:
"any substance or combination of substances presented as having properties of preventing or treating disease in human beings; or any substance or combination of substances that may be used by or administered to human beings with a view to: restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or making a medical diagnosis." Currently, medical devices in the EU are regulated by three directives (the Medical Device Directives):
Council Directive 93/42/EEC on Medical Devices (MDD); Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD); Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD). The MDD is applicable to all medical devices, which are defined as "any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; investigation, replacement or modification of the anatomy or of a physiological process; control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means."
This includes items such as heart valves, hip replacements, contact lenses, bandages, inhalers and certain software apps.
The AIMDD concerns active implantable medical devices, meaning any medical device which relies on a source of energy or power, other than that directly generated by the human body or gravity, which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, which is intended to remain there after the procedure. This includes devices such as pacemakers, insulin pumps and cochlear implants.
The IVDMD concerns any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens. This includes items such as pregnancy tests, blood glucose meters and HIV tests.
Before they could take effect, the Medical Device Directives required transposition into domestic law. In the UK this was achieved by the Medical Devices Regulations 2002/618. As a result of the diverging interpretations, the EU framework has been applied somewhat inconsistently across the Member States. To address this, in September 2012 the European Commission presented two legislative proposals on medical and in vitro diagnostic devices. This process culminated in two new directly applicable regulations being adopted 25 May 2017...