4. In the Medicines (Dental Filling Substances) Order 1975(2)—
(a)in paragraph (1) of Article 2 (application of specified provisions of the Act to dental filling substances) 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. 1975/533.