These Regulations deal with the marketing of medical devices generally and specific arrangements for systems and procedure packs, custom-made devices and devices intended for clinical investigations. Medical devices covered in the Regulations must generally meet the essential requirements, and must be CE-marked according to the conformity assessment procedures. Arising out of the conformity assessment procedures, there are specific obligations placed on manufacturers of devices or their authorised representatives, and on the notified bodies involved in carrying out assessments in respect of devices.
These Regulations have since been amended by the Medical Devices (Amendment) (Great Britain) Regulations 2023, which can be found under 'Amendments' below.
