UK MHRA updates advice on drug/device borderline cases
This article was originally published in RAJ Devices
The UK Medicines and Healthcare products Regulatory Agency has issued updated guidance on regulatory criteria for drug/device borderline products1.
The new guidance, provided in an MHRA bulletin, is accompanied by an annex that contains a list of products and states whether, or in what situation, they are covered by either medical device legislation or medicines legislation. But some uncertainty still remains, for example, with ophthalmic products. Though the guidance clearly states that artificial tears are considered to be medical devices if therapeutic claims are made, and medicated drops are considered to be medicinal products, it says that viscoelastic/viscosurgical products “may become medicines if additional claims are made”. Moreover, solutions for preserving corneal material prior to transplant – which were neither regulated under the medical device regulations nor as medicinal products2 – have been added to the list of borderline ophthalmic products and will be “generally regarded as a Class III [high-risk] medical devices”.
A new section covering agents for transport nutrition and storage of organs intended for transplantation has also been added to the list of borderline products. These agents, which were previously classified as neither medical devices nor medicinal products, will generally be regarded as Class III medical devices.
The updated UK guidance takes into account European consensus on these products. The MHRA document notes that, though the European Commission has published guidance on this issue (MEDDEV 2.1/3)3, it has not been updated since amendments were made to the European medical devices legislation, via Directive 2007/47/EC4. However, it adds that the commission in December 2008 issued a “manual of decisions” that contains information on specific borderline cases5.
References
1. Bulletin No 17: Medical Devices and Medicinal Products, March 2009, www.mhra.gov.uk/home/groups/es-era/documents/publication/con007498.pdf
2. Personal communication, MHRA, 23 March 2009
3. European Commission, MEDDEV 2.1/3 rev 2, July 2001, http://ec.europa.eu/enterprise/medical_devices/meddev/2_1_3____07-2001.pdf
4. Directive 2007/47/EC, OJ, 21 September 2007, L247, 21-55, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:247:0021:0055:EN:PDF
5. European Commission, Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices, Version 1.3, 2 December 2008, http://ec.europa.eu/enterprise/medical_devices/wg_minutes_member_lists/Version1_3_12-2008.pdf