Medical Device Regulations in Europe
Log into RAMS to download the documents listed below along with more regulations and guidances for the European Union.
Related services:
- CE Mark Certification for Medical Devices
- Clinical Evaluation Reports (CER) for Medical Devices in Europe
- EU IVDR Gap Assessment and CE Transition for IVD Companies
- EU MDR Compliance Consulting for Cosmetic and Aesthetic Products
- EU Medical Device Vigilance Reporting in Europe
- EU Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
- European Authorized Representative for Clinical Trials
- European Authorized Representative for Medical Device Companies
- European MDR 2017/745 Gap Assessment and CE Transition Strategy
- European Union Medical Device Classification
- In Vitro Diagnostics Regulation (EU IVDR) On-Site Training
- IVD Certification and Registration to Obtain CE Marking in Europe
- Medical Device and IVD Emergency Use Routes in Europe
- Medical Device Technical File and Design Dossier for EU CE Marking
- Switzerland Representative for Medical Device Companies
- UKRP and Brexit consulting for medical device companies
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Download | IVDR White Paper | 12/02/2021 | ||
| Log in | Council Directive 90.385.EEC (AIMDD) | 90/385/EEC | 06/1990 | English |
| Log in | Council Directive 93.42.EEC (MDD) | 93/42/EEC | 06/1993 | English |
| Log in | Council Directive 98.79.EC (IVDD) | 98/79/EC | 12/2011 | English |
| Log in | Regulation (EU) 2017.746 (IVDR) | 2017.746 | 05/2017 | English |
| Log in | Regulation (EU) 2017.745 (MDR) | 2017.745 | 05/2017 | English |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | MDCG Guidance Documents | English |
