Explanatory Memorandum to COM(2001)480 - Amendment of Council Directive 93/42/EEC, as amended by Directive 2000/70/EC, as regards medical devices incorporating stable derivates of human blood or human plasma - Main contents
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| dossier | COM(2001)480 - Amendment of Council Directive 93/42/EEC, as amended by Directive 2000/70/EC, as regards medical devices incorporating ... |
|---|---|
| source | COM(2001)480  |
| date | 22-08-2001 |
Directive 2000/70/EC amends Directive 93/42/EEC, by extending its scope to devices incorporating stable derivatives of human blood or human products.
After the approval of the Common Position by the relevant European Parliament Committee - that led to Directive 2000/70/EC -Member States drew the Commission's attention to the fact that there was a mistranscription in the wording as agreed by the Council.
The existence of this mistranscription was ascertained by the experts of all parties involved in its drafting: Council, Parliament, Commission. It was also accepted that the mistranscription might lead to confusion in interpreting the provisions of the Directive, and that the text should be clarified.
The introduction of an amendment for discussion in the plenary session of the European Parliament, envisaged at a certain stage, was abandoned since amendments would imply the opening of a new reading, under the co-decision procedure. This would have substantially delayed the approval of the Directive for which there was a pressing need and an agreement on substance.
The preferred solution, reached by consensus with the Presidency and the European Parliament's rapporteur, was for the Commission to introduce a proposition for a new Directive to the European Parliament and the Council, giving expression to what had effectively already been agreed.
In this framework the Commission proposes this new Directive, containing the required amendments to clarify the wording of Directive 2000/70/EC.