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