The Medical Devices (Consequential Amendments—Medicines) Regulations 1994

Explanatory Note

(This note is not part of the Regulations)

These Regulations amend the Medicines Act 1968 (“the Act”) and Orders under it in consequence of the implementation of Council Directive 93/42/EEC concerning medical devices (O.J. No. L169 12.7.93 p.1) by the Medical Devices Regulations 1994 (S.I. No. 3017).

Regulation 2 amends the definition of “medicinal product” in section 130 of the Act so that it does not include certain medicated dressings.

Regulation 3 amends the Medicines (Surgical Materials) Order 1971 so that it ceases to apply provisions of the Act to certain surgical ligatures, surgical sutures and absorbent or protective materials.

Regulation 4 amends the Medicines (Dental Filling Substances) Order 1975 so that provisions of the Act cannot be applied to dental filling substances by appointing an additional appointed day. No such day has been appointed for the purposes of that Order and so the Act has not been applied to substances used for filling dental cavities.

Regulation 5 amends the Medicines (Specified Articles and Substances) Order 1976 so that it ceases to apply provisions of the Act to certain intra-uterine contraceptive devices and to substances associated with contact lenses. Regulation 5 also amends that Order so that provisions of the Act cannot be applied to contact lenses from an additional appointed day. No additional appointed day has been appointed for the purpose of applying provisions of the Act to contact lenses.