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Questions Answers for EU Medical Devices Regulation

Updated: 27 February 2019

Practical considerations related with medical device implementation along with in vitro diagnostic medical devices regulations are included in Question and Answer document published by European Medicines Agency. This document can impart assistance to applicants regarding the various activities of agency.

It contains several questions such as the description of Article 117 and its meaning for medicinal products, what would be the impact of Article 117 on applications related to new marketing authorization. Other questions such as when would be the need to submit certificate or declaration for Marketing Authorization Application or is there any requirement to provide updated or new declaration or certificate if there are variations in devices are also incorporated in this document.

Detailed answers have been given in the document which will be surely beneficial for the applicants.