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  EU-MDR and IVDR Roadmap Published

The Competent Authorities for Medical Devices, CAMD, Implementation Taskforce published the Medical Devices Regulation/In-vitro Diagnostics Regulation (MDR/IVDR) Roadmap. You can download the roadmap from https://www.camd-europe.eu/wp-content/uploads/2018/05/NEWS_171107_MDR-IVDR_RoadMap_v1.3-1.pdf

 

The contents include:

Clinical Evaluation & Clinical Investigation (MD)

Performance Evaluation & Performance Studies (IVD)

Scope & Classification

Notified Bodies & Conformity Assessment

Post-Market Surveillance & Vigilance for both MD and IVD

Eudamed & UDI

Market Surveillance

IVD-specific Issues

Over-arching & Cross-cutting Priorities

 

In addition, there are two documents that include frequently asked questions.

 

For the EU-MDR, go to https://www.camd-europe.eu/wp-content/uploads/2018/05/FAQ_MDR_180117_V1.0-1.pdf

 

For the EU-IVDR go to https://www.camd-europe.eu/wp-content/uploads/2018/05/FAQ_IVDR_180117_V1.0-1.pdf

 

 

 
 
 
 
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