Glossary

Technology that enables medical devices to learn from data and improve performance, such as diagnostic imaging systems or predictive algorithms.

EU regulatory framework governing medical devices, effective May 2021, replacing previous directives.

Manufacturer documentation explaining safe and effective device use, including warnings and operating instructions.

EU regulation governing diagnostic tests (blood tests, tissue analysis), effective May 2022.

Single audit satisfying requirements of multiple countries (Australia, Brazil, Canada, Japan, U.S.).

Pre-authorized plan allowing device modifications without new submissions, especially for AI/ML devices.

Standalone software performing medical functions without being part of hardware (e.g., diagnostic apps).

Region overseen primarily by Australia's TGA.

Region including South America, Central America, Mexico, and Caribbean.

Regulatory submission requesting authorization to conduct a clinical study of a medical device in human subjects.

Common questions and answers about a product or regulatory topic.

Global collaboration of regulators working to harmonize medical device requirements across countries.

Influential medical expert whose opinions shape clinical practice and industry strategy.

UK regulatory authority for medicines and medical devices.

FDA's most rigorous approval pathway for high-risk Class III devices, requiring clinical evidence.

Australia's regulatory authority for medical devices and medicines.

Region including East Asia, Southeast Asia, South Asia, and Oceania.

Region including Saudi Arabia, UAE, Egypt, and neighboring countries.

EU regulatory body overseeing medicines and certain high-risk medical devices.

U.S. federal agency regulating medical devices, drugs, and food to protect public health.

Legal rights protecting innovations, including patents, trademarks, and trade secrets.

Commonly refers to EU Medical Device Regulation (EU-MDR).

Markets and operations conducted outside U.S. borders.

Clinical evidence from actual use (health records, registries, wearables) outside traditional trials.

Full designation for UK's independent regulatory authority post-Brexit.

Combined geographic territory for business and regulatory operations.

Taiwan, regulated by the Taiwan Food and Drug Administration (TFDA).