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Safety of Medical Robots, Regulation, and Standards
Published in Paolo Barattini, Vicentini Federico, Gurvinder Singh Virk, Tamás Haidegger, Human–Robot Interaction, 2019
The European Union, due to special political circumstances and history, has a unique system. EU Medical Device Regulation (MDR) requires manufacturers to obtain a certificate for each medical device, a CE marking, issued by a notified body. The notified body conducts the conformity assessment by auditing the quality system of the manufacturer and reviewing the product and relevant technical documents provided by the manufacturer to assess the safety of the product. The clinical benefit is not mandated to be demonstrated except for certain groups of medical devices such as active implants. Details of the EU product safety system can be found in [2].
Regulatory requirements and optimization of multiple criteria decision analysis to quantify the benefit-risk assessment of medical devices
Published in Expert Review of Medical Devices, 2023
Both the clinical evaluation section of the Europe (EU) Medical Devices Directive (MDD, 2007/47/EC) and the EU Medical Device Regulation (MDR 2017/745) require that ‘the evaluation of the undesirable side effects and acceptability of the benefit-risk-ratio shall be based on clinical data providing sufficient clinical evidence [14,15].’ MDR 2017/745 further explains that ‘benefit-risk determination means the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose when used in accordance with the intended purpose given by the manufacturer.’ The 2016 Clinical Evaluation Guidelines (MEDDEV 2.7/1 rev 4) from the EC further clarifies that, ‘Benefits and risks should be specified, e.g. as to their nature, probability, extent, duration, and frequency. The core issues are the proper determination of the benefit/risk profile in the intended target groups and medical indications, and demonstration of acceptability of that profile based on current knowledge and the state of the art in the medical fields concerned’ [16]. In the ANNEX XIV Clinical Evaluation of EU MDR 2017/745, benefit assessment requires ‘a detailed description of intended clinical benefits to patients with relevant and specified clinical outcome parameters,’ and risk assessment should specify ‘methods to be used for examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and side effects.’