Links to Global MedTech Regulations
Here is your go-to-site to access links to MedTech Global Regulatory guidance documents.
Europe
Legal Texts and Guidances
- Medical Device Regulation MDR 2017/745
- In-Vitro Diagnostic Regulation IVDR 2017/746
- Medical Device Directive MDD 93/42/EC
- NANDO database
- The 'Blue Guide' on the implementation of EU product rules 2016
- Medical Device Harmonized Standards
- Pharmaceutical Directive 2001/83/EC
- EUDAMED: European Database on Medical Devices
- Draft UK legislation (Brexit)
- eIFU regulation - (EU) 207/2012
- CLP legislation - CMR Annex VI table 3.1 (Page 472)
- Implementing Act 2017/2185 List of Codes & corresponding type of Devices
Associations, Competent Authorities & Others
USA
Brazil
China
Canada
Argentina
Links to regulations are provided in text. Also see our EU regulation list of guidance and legal text. And our MedTech Glossary
