S.L. 427.10 Art. 4Applicability. Cap. 458. Cap. 458. Cap. 458. S.L. 427.35 Cap. 458.

(1) Where an active implantable medical device is intended to administer a substance defined as a medicinal product within the meaning of article 2 of the Medicines Act, that device shall be governed by these regulations, without prejudice to the provisions of the Medicines Act with regard to the medicinal product.

(2) (a) Where an active implantable medical device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of article 2 of the Medicines Act and which is liable to act upon the human body with action that is ancillary to that of the device, that device shall be evaluated and authorised in accordance with these regulations.

(b) Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of article 2 of the Medicines Act and which is liable to act upon the human body with action that is ancillary to that of the device, hereinafter referred to as a "human blood derivative", that device shall be assessed and authorised in accordance with these regulations.

(3) These regulations constitute a specific Directive within the meaning of regulation 4(5) of the Electromagnetic Compatibility Regulations.

(4) These regulations shall not apply to:

(a) medicinal products covered by the Medicines Act. In deciding whether a product falls under that Act or these regulations, particular account shall be taken of the principal mode of action of the product;

(b) human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells with the exception of devices referred to in sub-regulation (2)(b);

(c) transplants or tissues or cells of human origin or to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in subregulation (2)(b);

(d) transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.