The medical device industry operates within a complex and continuously evolving regulatory environment. This knowledge base brings together key global resources, regulatory authorities, standards organizations, and databases that support compliance, quality management, and product lifecycle activities.

These references are widely used by manufacturers, regulatory professionals, quality managers, and clinical specialists working with medical devices worldwide.

Regulatory Authorities & Guidance

European Commission — Medical Devices
https://health.ec.europa.eu/medical-devices_en

EU MDR (Regulation (EU) 2017/745)
https://eur-lex.europa.eu/eli/reg/2017/745/oj

MDCG Guidance Documents
https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en

FDA — Center for Devices and Radiological Health (CDRH)
https://www.fda.gov/medical-devices

IMDRF (International Medical Device Regulators Forum)
https://www.imdrf.org

Standards & Quality Management

ISO 13485 — Quality Management Systems for Medical Devices
https://www.iso.org/standard/59752.html

ISO 14971 — Risk Management for Medical Devices
https://www.iso.org/standard/72704.html

IEC 62366 — Usability Engineering
https://www.iec.ch/dyn/www/f?p=103:85:0::::FSP_LANG_ID:25

Databases & Regulatory Tools

EUDAMED Information Pages
https://health.ec.europa.eu/medical-devices/eudamed_en

GUDID (Global Unique Device Identification Database)
https://accessgudid.nlm.nih.gov

Devices@FDA Database
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases