1994 No. 3119
The Medical Devices (Consequential Amendments—Medicines) Regulations 1994
Made
Laid before Parliament
Coming into force
The Secretary of State and the Minister of Agriculture, Fisheries and Food, acting jointly, in exercise of the powers conferred by section 2(2) of the European Communities Act 19721 and of all other powers so enabling them, hereby make the following Regulations:
Citation and commencement1
These Regulations may be cited as the Medical Devices (Consequential Amendments—Medicines) Regulations 1994 and shall come into force on 1st January 1995.
Amendment of the Medicines Act 19682
In section 130 of the Medicines Act 19682 (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/EEC3 (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.
Amendment of the Medicines (Surgical Materials) Order 19713
In the Medicines (Surgical Materials) Order 19714—
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—
Exception4
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/EEC3 (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.
Amendment of the Medicines (Dental Filling Substances) Order 19754
In the Medicines (Dental Filling Substances) Order 19755—
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—
Exception3
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/EEC3 (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.
Amendment of the Medicines (Specified Articles and Substances) Order 19765
In the Medicines (Specified Articles and Substances) Order 19766—
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—
Exception3
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/EEC3 (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.
(This note is not part of the Regulations)