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Directive in the European Union that restricts the use of specific hazardous materials found in electronic and electrical devices.

EU regulation that sets standards for the marketing of in vitro diagnostic medical devices in the EU, increasing the stringency of requirements.

Indicates that a medical device complies with the applicable EU legislation and can be sold within the European market.

An FDA pathway for low- to moderate-risk devices that are novel and therefore do not have a valid predicate device.

The UK's regulatory agency responsible for ensuring that medicines and medical devices work and are acceptably safe.

Former EU directive for in vitro diagnostic medical devices, now replaced by the In Vitro Diagnostic Regulation (IVDR).

Chinese agency responsible for creating comprehensive supervision and management of medical devices, ensuring safety and effectiveness.

Allows a medical device to be used in a clinical study in order to collect safety and effectiveness data.

Replaces the Medical Devices Directive (MDD). Key requirements include clinical evaluation, post-market surveillance, and a unique device identification system.

A series of technical standards for the safety and effectiveness of medical electrical equipment.

Monitoring the safety and effectiveness of medical devices after they have been released on the market.

EU regulation that impacts medical devices by controlling the use of hazardous substances in the manufacturing process.

Regulates the conduct of clinical trials on medical devices in the European Union, ensuring the protection of participants and the collection of reliable data.

Responsible for ensuring the safety and efficacy of pharmaceuticals and medical devices in Japan.

Part of the Code of Federal Regulations (CFR) related to Quality System Regulation requirements for medical device manufacturers in the U.S.

Oversees the safety and efficacy of medical devices in the U.S. Key points include premarket notification 510(k), premarket approval (PMA), and Quality System Regulation (QSR).

Responsible for the regulation and approval of medical devices in Brazil, ensuring they are safe and effective.

The regulatory body in Australia responsible for regulating medical devices, ensuring safety, quality, performance and presentation.

Allows manufacturers to produce custom devices without adhering to the standard FDA premarket approval requirements or 510(k) notification under special circumstances.

Provides a pathway for medical devices that treat or diagnose diseases affecting fewer than 8,000 individuals in the U.S. annually.

Former European Union directive that has been replaced by the EU MDR; it regulated the distribution and quality of medical devices in Europe.

FDA regulations that define the criteria for acceptance of electronic records, electronic signatures, and handwritten signatures executed to electronic records.

Aims to achieve greater uniformity between national medical device regulatory systems, facilitating the exchange of information and encouraging convergence in regulatory practices.

An international standard for the application of risk management to medical devices.

FDA's regulations requiring manufacturers to ensure products are safe, pure, and effective. Includes equipment, facilities, and controls for manufacturing processes.

An FDA requirement for manufacturers to report certain device-related adverse events and product problems.

Former EU legislation for active implantable medical devices, superseded by EU MDR.

Not a direct medical device regulation, but imposes requirements on medical devices that handle patient health information. Key aspects include Privacy Rule and Security Rule.

An international standard that outlines the requirements for a quality management system specific to the medical device industry.