Regulation 3 Amendment of the Medicines (Surgical Materials) Order 1971

in Article 3 (application of specified provisions of the Act to certain surgical materials) after the words “it is hereby directed that” there shall be added the words “, subject to Article 4 of this Order,”; and

after Article 3 the following Article shall be inserted—

“Exception

4

No provision of the Act shall have effect under Article 3 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^f2 (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.”.