The Medical Devices (Consequential Amendments—Medicines) Regulations 1994

• Citation: S.I. 1994/3119
• Sections: 5

Section 1 Citation and commencement

These Regulations may be cited as the Medical Devices (Consequential Amendments—Medicines) Regulations 1994 and shall come into force on 1st January 1995.

Section 2 Amendment of the Medicines Act 1968

In section 130 of the Medicines Act 1968 (meaning of “medicinal product” and related expressions)—

(a) in subsection 5(b) for the words “where the medication has a curative function which is not limited to sterilising the dressing” there shall be substituted the words “within subsection (5A) below”;

(b) after subsection (5) the following subsection shall be inserted—

(5A) Medicated dressings are within this subsection (and accordingly are not excluded from the definition of “medicinal product” by subsection (5)(b) above) if—

(a) their medication has a curative function which is not limited to sterilising the dressing; and

(b) they are not dressings of a kind to which the requirements of Article 2 of Council Directive 93/42/ EEC (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.

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

In the Medicines (Surgical Materials) Order 1971 —

(a) 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

(b) 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 (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.

Section 4 Amendment of the Medicines (Dental Filling Substances) Order 1975

In the Medicines (Dental Filling Substances) Order 1975 —

(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—

Exception

(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 (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.

Section 5 Amendment of the Medicines (Specified Articles and Substances) Order 1976

In the Medicines (Specified Articles and Substances) Order 1976 —

(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—

Exception

(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 (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.