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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

EC Issues Additional Guidance on Device Vigilance System

Someone may say it comes late in the game since MDR should NOW be in implemented but it is helpful for the new MIR form and for a better understanding of the collaboration among authorities.

Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8

The document:


  • Clarifies some of the existing definitions.

  • Introduces a new Manufacturer’s Incident Report and the new template for Field Safety Notice.

  • Introduces device specific vigilance guidance.

  • Provides further detail in relation to the area of the coordination of vigilance issues amongst Competent Authorities.

  • Clarifies the differences between the EU NCAR exchange and the IMDRF NCAR exchange.


Categories: News
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