The Medical Devices (Amendment) Regulations 2003

New regulation 19A of the principal Regulations

9.  In Part II of the principal Regulations (general medical devices), after regulation 19 (registration of persons placing general medical devices on the market) there is inserted the following regulation—

“Additional requirements relating to use of animal tissues

19A.— (1) Subject to paragraph (3), no person shall put into service or supply a relevant device (if that supply is also a placing on the market or if that supply is of a relevant device that has been placed on the market) if that device is manufactured utilising either animal tissue which is rendered non-viable or non-viable products derived from animal tissue unless—

(a) there is in respect of that device a risk analysis and risk management scheme which is in accordance with the requirements of Directive 2003/32; and

(b) the manufacturer of the device has fulfilled his obligations under the procedures within that scheme.

(2) If collagen, gelatine or tallow is of animal origin and has been used in the manufacture of a relevant device, then subject to paragraph (3), no person shall put into service or supply that device (if that supply is also a placing on the market or if that supply is of a device that has been placed on the market), unless that collagen, gelatine or tallow was fit for human consumption.

(3) Paragraphs (1) and (2) shall not apply to a relevant device which is not intended to come into contact with the human body or which is intended to come into contact with intact skin only.”.