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 used according to manufacturer’s instructions. The MDR requires the generation of a Clinical Evaluation Report (CER) after the investigation of a medical device, which is part of the technical documentation for the CE-marking process and such CER-related services are provided by CROs. Re-submission of technical documentation in case of high-risk devices may be required prior to CE-approval, delaying thus the approval timelines. MDR requires more data to prove device’s safety and performance and more stringent conditions for comparative evaluations. In comparative investigations the MDR requires the approval of both device manufacturers for clinical evaluation. A greater volume of data will be generated by device manufacturers and their representatives and better data interpretation will be necessary to support their safety and performance claims. The two new EU directives will improve the quality of scientific data required to support the performance and safety claims of the device manufacturers and require the CROs to raise the extent and quality of data collection and analysis during clinical investigations on medical devices.