USEFUL WEBSITES
- European Commission
- International Medical Device Regulators Forum (IMDRF)
- Therapeutic Goods Administration (TGA)
- Food and Drug Administration (United States FDA)
- Medicines and Healthcare products Regulatory Agency (MHRA UK)
- Medical Device Coordination Group (MDCG) website
- Health Canada
- ARCS Australia Ltd (previously the Association of Regulatory and Clinical Scientists)
REGULATIONS
- EU In Vitro Diagnostic Regulations (IVDR) 2017/746
- EU Medical Device Regulations (MDR) 2017/745
- Food, Drug and Cosmetic Act 1938
- FDA Medical Devices; Quality System Regulation Amendments
- FDA Code of Federal Regulations (CFR) Title 21
- Therapeutic Goods Act 1989
- Therapeutic Goods (Medical Devices) Regulations 2002
- Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021
USEFUL GUIDANCE
- Artificial Intelligence (AI) and medical device software: How we regulate AI medical devices
- Australian Regulatory Guidelines for Medical Devices (ARGMD)
- Cybersecurity in Medical Devices Frequently Asked Questions (FAQs) (FDA)
- European Union (EU) Harmonised Standards List – applies to Medical Device Regulations (MDR) 2017/745
- FDA – Recognised Consensus Standards
- FDA – Guidelines
- GHTF – Summary Technical Documentation (STED) for Medical Devices
- GHTF – STED for In Vitro Diagnostic Medical devices
- IMDRF – Software as a Medical Device (SaMD): Application of Quality Management System
- IMDRF – SaMD: Clinical Evaluation
- IMDRF – SaMD: Possible Framework for Risk Categorisation and Corresponding Considerations
- IMDRF SaMD: Key Definitions
- MDR Documentation Submissions – Best Practice Guidelines
- MEDDEV 2.7/1 Clinical Evaluation: under Directives 93/42/EEC and 90/385/EEC
- MEDDEV 2.12/1 Guidelines on a Medical Device Vigilance System
- MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
- Medical Device Cyber Security Guidance for Industry (TGA) website
- Questions and Answers about eMDR – Electronic Medical Device Reporting (FDA)
- Therapeutic Goods Administration (TGA) Priority applicant guidelines for medical devices (including IVDs)
- TGA Regulation of Software based medical devices
- Transition Timelines from the Directive to the IVDR