News and Views: High Priority
Update of the Medical Devices Directives
Please note that a full review of the AIMDD, the MDD and the IVD took place and not only the very limited review than initially required by the MDD. Therefore, the text refers to all directives and should thus be carefully evaluated!
Regarding the timeline: The text must be published in the Official Journal of the European Union. Once officially published member states will follow their own legal procedures to transpose the update of the directive into their national laws. All timelines will be provided by MDSS once available. However, since the text is approved, please be informed that most regulators consider the current update as “a clarification” of the old text only!! You may be confronted soon with some of the updates during any assessment procedures or competent authority inspections of your products.
Should you have any questions or would like to have any clarification, please do not hesitate to contact us. Our idea is to collect all questions and provide feedback to all clients accordingly. Certainly you should receive feedback on your questions as soon as possible.
Your MDSS Team
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