Regulatory Pathway for Medical Device Manufacturers

This document will consider various medical device regulations that are available and used in Great Britain. For the approval of medical devices, Great Britain is considered to represent England, Scotland and Wales. For regulatory purposes, Northern Ireland will have different requirements as will the European Union territories and will be excluded from the scope of this positional paper. Medical devices are generally classified as medical devices, software as a medical device, in-vitro diagnostic devices and active implantable devices. This paper will not consider combination devices or advanced therapeutic medical devices such as devices that use human tissue or plasma products. The current applicable legislation in Great Britain is Medical Devices Regulations 2002(SI 2002 No 618, as amended). No consideration has been given to future UK legislation which is currently subject to public consultation.

Supporting documents