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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).

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

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.

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

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

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

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

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

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

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

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

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

The federal regulator of therapeutic products, including medical devices in Canada. Ensures that such products are safe, effective, and of high quality.

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

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

Former European Union directive that has been replaced by the EU MDR; it regulated the distribution and quality of medical devices in Europe.

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

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

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

Former EU legislation for active implantable medical devices, superseded by EU MDR.

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

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.

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

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

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.

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