I. Current regulatory requirements for clinical research of medical devices
Both AIMD and MDD regulations of the European Union set clinical data requirements for medical devices. Clinical data requirements are the responsibility of the authorities in the constituent countries. It is stipulated in Annex VII of AIMD and Annex X of MDD that all medical devices should have clinical evidence, that is, all medical devices with CE mark should have clinical data, including data collected from the literature and/or results of clinical studies. MDD decrees also specify that implanted medical devices or class ⅲ medical devices must have Clinical data, Clinical data can be obtained from the existing medical and non-medical data Evaluation (called Clinical Evaluation). It can also be obtained from Clinical Investigation or Clinical Trail, or both.
Ii. Requirements for clinical trials
Medical device manufacturers shall conduct clinical trials in qualified medical institutions in accordance with the regulations on the management of clinical trials of medical devices. For Class ⅱA, ⅱB, and ⅲ devices, clinical trials were initiated within 60 days of receiving notification of approval for clinical trials. Unless the medical establishment considers that the trial is incompatible with public health and policy. The member State may approve the initiation of the appropriate clinical trial within 60 days as required by the ethics Committee. Member States may authorise manufacturers to carry out clinical trials, except for specifically mentioned medical devices. Ethical Committee approval of the clinical trial is required. Clinical trials should be supervised in accordance with medical device testing regulations. Test regulations are regularly adjusted in accordance with the requirements of the Medical Device Committee. It is necessary for Member States to take appropriate measures to protect subjects’ health and policies. The manufacturer or its agent shall keep and record the test records. The law stipulates that medical devices should be supported by clinical data. Clinical data can be derived from the evaluation of existing medical and non-clinical data (clinical evaluation) or from clinical trials.
In accordance with the requirements of the supervision of medical devices, the general requirements, special requirements and basic requirements for clinical data of medical devices are stipulated in the European Medical Devices Act. The basic requirements are applicable to all medical devices, including routine risk, warning, physical and chemical performance, and labeling requirements. For implantable and Category III devices, compliance requirements for performance characteristics must be verified in clinical trials and side effects evaluated, as required by the statute.
As an important part of the pre-marketing supervision and management of medical devices, clinical trials play an important role in ensuring the safety and effectiveness of medical devices. Be familiar with the specific requirements of the European Union for clinical trials of medical devices, and be able to help your products in the corresponding clinical trials.
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Post time: Sep-02-2022