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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.
ECLI:EU:C:1997:65
61996CC0294
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Important legal notice
61996C0294
European Court reports 1997 Page I-01781
Opinion of the Advocate-General
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.
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.
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.
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.