5. In the Medicines (Specified Articles and Substances) Order 1976(2)—
(a)in Article 2 (application of specified provisions of the Act to articles and substances described in Schedule 1) after the words “it is hereby directed that, subject” there shall be added the words “to Article 3 of this Order and”; and
(b)after Article 2 the following Article shall be inserted—
3. No provision of the Act shall have effect under Article 2 of this Order in relation to an article or substance of a kind to which the requirements of Article 2 of Council Directive 93/42/EEC(1) (placing medical devices on the market and putting them into service) apply or would apply but for Article 4 (devices intended for special purposes) or 22 (transitional provisions) of that Directive.”.
O.J. No. L 169 12.7.93 p.1.
S.I. 1976/968.