On September 28th, MedTech Europe published two flowcharts to help navigate the requirements of the medical devices (MD) and in vitro diagnostic (IVD) regulatory frameworks during the transition from the existing 3 EU directives, to two new regulations. The various processes are mapped, showing what needs to be followed in order to CE mark and maintain a product on the European market.
These flowcharts provide a high-level overview of the requirements stated under the In Vitro Diagnostic Medical Devices Regulation 2017/746/EU, and the Medical Devices Regulation 2017/745/EU, both of which came into force on 25th May. Both of these Regulations bring a number of improvements, helping to modernise the current systems for medical devices and in vitro diagnostics.
To allow manufacturers and authorities to adapt, a transition period of 3 years has been allowed for the MD Regulation (spring 2020) and 5 years for the IVD Regulation (spring 2022).
The flowcharts are linked below:
Overview of requirements under the Medical Devices Regulation 2017/745/EU
Overview of requirements under the In Vitro Diagnostic Medical Devices Regulation 2017/746/EU
This regulatory requirement has played a large role in the work that Trauma Management Healthcare Technology Cooperative (HTC) has undertaken so far and the use of such tools will become very useful in supporting new medical devices to market in the future.
