China 
Africa 
Explore chapters and articles related to this topic
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].
Maintenance (and Improvement)
Published in William I. White, Excellence Beyond Compliance, 2018
A closely related function is that of notified body. A notified body is an organization nominated by a member of government and notified by the European Commission. A notified body is nominated based on specified requirements, such as knowledge, experience, independence, and resources to conduct conformity assessments. The primary role of a notified body is to provide services for conformity assessment of products in support of CE Marking in Europe. This normally means assessing the conformity of the manufacturer's products to the essential requirements listed in device directives and regulations.
Life After Registration
Published in Gurmeet Naroola, Robert Mac Connell, How to Achieve ISO 9000 Registration Economically and Efficiently, 2022
Gurmeet Naroola, Robert Mac Connell
Notified Body: A notified body is an agency considered competent in the field of a specific directive and who is authorized by EU member states to test, verify and certify product per the directive.
Artificial intelligence in medical device software and high-risk medical devices – a review of definitions, expert recommendations and regulatory initiatives
Published in Expert Review of Medical Devices, 2023
Alan G Fraser, Elisabetta Biasin, Bart Bijnens, Nico Bruining, Enrico G Caiani, Koen Cobbaert, Rhodri H Davies, Stephen H Gilbert, Leo Hovestadt, Erik Kamenjasevic, Zuzanna Kwade, Gearóid McGauran, Gearóid O’Connor, Baptiste Vasey, Frank E Rademakers
The EU AI Act proposes to regulate high-risk AI systems that could have an adverse impact on the safety or fundamental rights of people [153]. Unless its text is amended, providers of high-risk AI systems (most likely manufacturers of AI medical devices [154]) will have to register them in the EU database before placing them on the market. As part of their conformity assessment for the MDR, AI medical devices will have to comply with requirements dealing with risk management and quality criteria concerning the training, validation, and testing of data sets. Manufacturers will have to provide technical documents describing compliance with applicable rules and keep records that ensure an appropriate level of traceability of the system’s functioning including accuracy, robustness, and cybersecurity throughout its lifecycle. This is intended to enable users to interpret the output and have human oversight of an AI system. An AI medical device will fall within the Act’s scope if a notified body is involved in its conformity assessment under sectorial legislation.