The new MD Regulation will replace the 93/42 and the 90/385 EEC Directives and is now in technical and legal review. This regulation will introduce significant changes, for example: a strighter control on technical documentation a more stringent clinical evaluation and post-market surveillance and obligations also for importers and distributors.
This drafting process started on 2012 after a public consultation, will probably end on the first quarter of 2017 and the MDR will have a transition time of three years from publication.
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