Publication of Guide for Classification of Medical Devices Guide

Publication of Guide for Classification of Medical Devices Guide In the European Union, Medical Devices are classified according to “Article 51 – Classification of Devices” and the “Rules” set out in “Annex VIII – CLASSIFICATION RULES” of Regulations (EU) 2017/745 and 2017/746 “. In many cases, applying the rules is difficult as more and more […]

Publication of the list of harmonized standards for Medical Devices

Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on harmonized standards for medical devices developed in support of Regulation (EU) 2017/745 has been published. You should then check whether these standards apply to your in vitro diagnostic medical devices or quality management system activities. If so, you must implement them as evidence of compliance […]

Publication of the list of harmonized standards for in vitro Medical Devices

Publication of the list of harmonized standards for in vitro Medical Devices Commission Implementing Decision (EU) 2021/1195 of 19 July 2021 on harmonized standards for in vitro diagnostic medical devices developed in support of Regulation (EU) 2017/746 has been published. You should then check whether these standards apply to your in vitro diagnostic medical devices […]