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MDR Checklist for the Clinical Product Lifecycle
The following checklist gives an overview of the required documents essential as per MDR for a precise implementation of the clinical product lifecycle.
Since now the medical device coordination group (MDCG) has published some new guidelines on how to implement the MDR (EU) 2017/745 more specifically pertaining to clinical investigation and clinical evaluation. And it is already an established fact that the documents and records required by the MDR is much more extensive than …
European regulations and guidelines
- Regulation (EU) 2017/745 on medical devices, MDR
- Regulation (EU) 2017/746 on in-vitro diagnostics, IVDR
- Guidance – MDCG endorsed documents and other guidance
- European Medicines Agency (EMA) Guidance
National laws and guidelines
Here we provide you some external links, you will find useful.
MDR Competence Network