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New Guidance published by the Commission!

The  two  new  Regulations  on  medical  devices  745/2017 (MDR) and  746/2017  (IVDR)(hereafter called the Medical DevicesRegulations) have been adopted and entered into force on 25 May 2017. The two Regulations, which are to replace three EU Directives, apply progressively until May 2020 for medical devices and May 2022 for in vitro diagnostic medical devices. Among the many novelties introduced, the two  Regulations enhance the focus of legislators on ensuring that devices placed on the EU market are fit for the new technological challenges linked to cybersecurity risks. In this respect, the new texts lay down certain new essential safety requirements for all  medical devices that incorporate electronic programmable systems and software that  are medical devices in themselves. They require manufacturers to develop and manufacture their products in accordance with the state of the art taking into account the principles of risk management, including information security, as well as to set out  minimum requirements concerning IT security measures, including protection against unauthorised access.

Read the compete document here. Please leave your comment/opinion below whether the document helpful for your MDR endeavor.

Categories: News

European Commission offers Guidance on UDIs!

Last Wednesday, the 4th of December 2019, the European Commission released new documents related to the technical specifications for unique device identifiers (UDIs).

Categories: News

Guidance on Implant Card

Medical Devices: Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices.

This document describes the intended use, content and information to be provided by the manufacturer together on the IC and a definition of fields to be completed by the implanting healthcare institutions or healthcare providers according to national law in Member States.

Example of IC Leaflet


Categories: News
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