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Gap Analysis
TOWARDS MDR COMPLIANCE
Medical Device manufacturers need to comply with the European Medical Devices Regulation 2017/745 (MDR).
An MDR-centered Gap Analysis represents the basis for identifying the best strategy to bring the product into the EU market.
It embeds a broad range of regulatory, development and quality aspects, including:
- Product classification
- Technical file
- Clinical Evaluation Reports (CER)
- Clinical investigation
- Product labels and instructions for use
- Post-Market Surveillance (PMS)
- Notified Body status
- Economic Operators
- Risk management file
The outcomes of the Gap Analysis will generate inputs for the product’s regulatory strategy and roadmap to the EU market.