Șerban Marius Roșu

In 2017 the European Commission changed and updated the legal framework regarding the medical devices, superseding the existing directives, with two new regulations which added new responsibilities for European Medicines Agency and national regulatory authorities. The two new regulations, the MDR 2017/745 on medical devices and IVDR 2017/746 on in vitro diagnostic devices are scheduled to be fully implemented (after a transition period) from may 26-th 2020 (MDR) and may 26-th 2022 (IVDR), respectively. During this transition period the existing EU directives (93/42/EEC, 98/79/EC and 90/385/EEC) will apply to any medical device tested to be put on the market but the manufacturers can opt to follow the new regulations under the condition of full compliance with them. The new directives demand a mandatory conformity assessment for all devices manufactured in the EU, to prove that they conform to the legal requirements, perform as claimed and are safe to use. Only after passing a conformity assessment the manufacturers can put a CE mark (Conformité Européenne) on their medical device. These conformity assessments will be conducted by accredited bodies, designated by EU member states. The procedure for obtaining the CE mark requires an audit of the manufacturer's technological workflow and an evaluation of the technical and scientific documentation supporting the performance and safety claims of the device. In the new legislation, the Clinical Research Organizations (CRO) are assigned a more important role in providing the scientific evidence and regulatory assistance during the whole process of placing a medical device on the market. The new MDR and IVDR directives emphasize a more robust clinical evaluation process to collect and analyze data pertaining to a medical device. They also require clinical evaluations to assess whether there are sufficient data to prove the compliance of the device with the requirements for safety and performance, when...