UK Law and Practice Contributed by: Jackie Mulryne, Ewan Townsend, Adela Williams and Libby Amos-Stone, Arnold & Porter
• irrationality; • procedural unfairness; and • legitimate expectation. 1.3 Different Categories of
General medical devices and active implantable devices fall within the following categories: • Class I – low risk; • Class IIa – medium risk; • Class IIb – medium risk; and • Class III – high risk. In vitro diagnostic (IVD) medical devices in Great Britain are currently categorised differently into four main groups – namely, those which are (there are different classifications under the EU IVDR that applies in Northern Ireland): • considered as general IVD medical devices; • within the classifications stated in Annex II List A of the IVDD (which is referred to in UK legislation); • within the classifications stated in Annex II List B of the IVDD; and • for “self-test” intended to be used by a per- son at home. The current UK law governing clinical trials of medicinal products is the Medicines for Human Use (Clinical Trials) Regulations 2004/1031, which transposed the EU Clinical Trials Directive 2001/20/EC into UK law, and has been amended to reflect the UK’s departure from the EU. Clini- cal trials must be conducted in accordance with good clinical practice (GCP), the terms of the approved protocol, clinical trial authorisation and research ethics committee (REC) approv- al. The EU Clinical Trials Regulation 536/2014, which came into full effect on 31 January 2022, does not apply in Great Britain but, as a result of the Northern Ireland Protocol, certain parts apply in Northern Ireland. 2. Clinical Trials 2.1 Regulation of Clinical Trials
Pharmaceuticals and Medical Devices There are three categories, or legal classifica- tions, of medicinal products, which determine the level of control over supply. In part, classi- fication rests on how much healthcare profes- sional (HCP) input is needed to diagnose and treat the conditions for which the medicine might be used. The three legal classifications are: • prescription-only medicines (POMs) – these have to be prescribed by a doctor or other authorised HCP and have to be dispensed from a pharmacy or from another specifically licensed place; • pharmacy (also known as P, over the counter or OTC) – these have an intermediate level of control and can be bought only from pharma- cies and under a pharmacist’s supervision; and • general sales list (GSL) – these may be bought from general retail stores or vending machines. Medical devices are given a classification depending on the level of risk associated with their use. This relates to the regulatory pathway for the product rather than the conditions on supply. How a medical device is classified will depend on factors such as: • the intended purpose of the device; • how long it is intended to be in use; and • if the device is invasive/surgically invasive, is implantable or active, or contains a substance which in its own right is considered to be a medicinal substance.
361 CHAMBERS.COM
Powered by FlippingBook