The MDCG provided a new Guidance Document!
This document provide guidance on relevant requirements under the Regulations. Where clarification is already covered by other MDCG guidances, this guidance on authorised representatives includes a reference...
You can also find more guidance documents here: https://lnkd.in/e_8YFMPt
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.
Last Wednesday, the 4th of December 2019, the European Commission released new documents related to the technical specifications for unique device identifiers (UDIs).
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:
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