Opinion of Mr Advocate General Lenz delivered on 18 February 1997. # Commission of the European Communities v Kingdom of Belgium. # Failure by a Member State to fulfil its obligations - Failure to transpose Directive 93/42/EEC - Medical devices. # Case C-294/96.

Opinion of the Advocate-General

1 In these Treaty infringement proceedings the Commission claims that the Kingdom of Belgium has failed to adopt the laws, regulations and administrative provisions needed to transpose Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (1) into national law.

2 Under Article 22(1) of the directive, the Member States were required to adopt the laws, regulations and administrative provisions needed to comply with the directive by 1 July 1994 and to inform the Commission thereof forthwith.

3 The Kingdom of Belgium does not dispute that the directive has not been transposed into national law within the time-limit set. It merely states that the requisite legislation is being prepared.

4 I accordingly propose that the Court should declare that, by failing to adopt, within the prescribed time-limit, the measures needed to comply with Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, the Kingdom of Belgium has failed to fulfil its obligations under the Treaty. I also propose that the Kingdom of Belgium should be ordered to pay the costs.

(1) - OJ 1993 L 169, p. 1.