MedTech Europe publishes flowcharts on the IVD Regulation and on the MD Regulation
Posted on 28.09.2017
MedTech Europe is delighted to publish two flowcharts which give an overview of the requirements under the In Vitro Diagnostic Medical Devices Regulation 2017/746/EU and the Medical Devices Regulation 2017/745/EU. MedTech Europe hopes that these two flowcharts will be a helpful resource for industry, economic operators, authorities and other actors to navigate the often complex requirements of the IVD and medical devices’ regulatory framework during the transition periods to comply with the IVD Regulation and the MD Regulation.
The flowcharts are designed to give a high-level summary, from the manufacturer’s perspective, of the various processes that need to be followed in order to CE mark and maintain a product on the European market. Requirements for other economic operators such as the authorised representative, importer and distributor are also included. The legal reference to the relevant Regulation is provided for every step under each flowchart.
Due to their detailed content, the format of the documents is A1 poster size. They can be downloaded from the MedTech Europe website here for the IVDR and here for the MDR.