Final adoption of EU reclassification Directive "by the end of this month":
This article was originally published in Clinica
The European Directive on the reclassification of joint implants, namely hips, shoulders and knees, should be finally adopted by the EU's College of Commissioners by the beginning of August. Despite delays following the positive vote by the article 7 committee on devices in January - caused by having to wait for all the linguistic versions to be ready - regulators now hope that this controversial legislation will be signed and sealed before the traditional EU summer break. Once the text has been adopted, it will be published in the Official Journal of the European Union. Member states will have six months to transpose it into their national laws, after which a transition period of 18 months will follow. This means that manufacturers of these implants will have to submit their design dossiers for notified body review two years from the adoption by the College of Commissioners.
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