Amendment of the Medical Devices Regulations 1994
13. The Medical Devices Regulations 1994(1) are amended as follows—
(a)in regulation 2(1) (interpretation), in the definition of “device” for “Council Directive 65/65/EEC” there is substituted “Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use”; and
(b)in regulation 3 (application of the Regulations)—
(i)in paragraph 2(c) for “Council Directive 65/65/EEC as last amended by Council Directive 93/39/EEC” there is substituted “Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use”; and
(ii)in paragraph (3) for “Council Directive 65/65/EEC” there is substituted “Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use”.