🔗 Useful Resources & Glossary
🌍 Important Regulations and Standards
| Source | Explanation | Link |
|---|---|---|
| MDCG | EU medical device regulations guidance and information documents | MDCG Official Page |
| 2017/745 MDR | European Union Medical Device Regulation | EUR-Lex MDR Text |
| 2017/746 IVDR | European Union In Vitro Diagnostic Devices Regulation | EUR-Lex IVDR Text |
| ISO Standards | International standards (ISO 13485, ISO 14971, ISO 14155, etc.) | ISO Official Website |
| ASTM Standards | American Society for Testing and Materials standards | ASTM Official Website |
| FDA | U.S. Food and Drug Administration, medical device regulations | FDA Medical Devices |
| SFDA | Saudi Arabia Food and Drug Administration | SFDA Official Website |
| EUDAMED | EU Medical Device Database (registration and traceability) | EUDAMED Portal |
📚 Glossary of Terms
MDR: Medical Device Regulation, EU medical device regulation (2017/745)
IVDR: In Vitro Diagnostic Regulation, EU in vitro diagnostic devices regulation (2017/746)
PMCF: Post-market clinical follow-up is the clinical monitoring process that takes place after a product is released to the market.
CRO: Clinical Research Organization
ANCHOR: Corrective and Preventive Action
NB: Notified Body, authorized organization
ISO 13485: Quality management system standard for medical devices.
ISO 14971: Risk management standard for medical devices.
ISO 14155: Medical device clinical trial standard
GSPR: General Safety and Performance Requirements (MDR Annex I)
MOC: Management of Change, the change management process.
EUDAMED: EU medical devices database and registration system.
SFDA: Saudi Arabia Food and Drug Administration
FDA: U.S. Food and Drug Administration
Legacy Product: Products that are currently available and regulated in the existing market.
📥 Additional Resources
- • MDR and IVDR Adoption Guidelines
- • ISO Standards Summary and Purchase Links
- • Clinical Trial Protocol Templates
- • Regulatory Updates and News
📌 Note:
This page will be updated regularly to ensure compliance with current legal regulations and standards. Furthermore, its scope can be expanded based on suggestions and requests from users.