The Regulatory Shift: From MDD/AIMDD ➡ MDR
This shift has introduced more rigorous requirements for clinical evidence, impacting all devices previously CE marked under MDD or AIMDD.
What are the key changes?
What clinical data can you use to support your legacy device?
Pre-market:
- Clinical investigation reports of the device concerned
- Clinical investigation reports or other studies reported in scientific literature for an equivalent device
- Reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated
- Other pre-market data, e.g. case reports
Post-market:
- PMS clinical data, complaint and incident reports
- PMCF studies, including post-market clinical investigations
- Independent clinical studies conducted using the device
- Device registries
- Data retrieved from the literature.
Note: All clinical data needs to be analysed (where appropriate-appraised) to determine clinical benefits, risks and benefit-risk ratios.
What factors does MDR reinforce, with respect to the CER?
How can Advena Ltd help?
- Comprehensive GAP Analysis- a thorough analysis of available clinical data and advise on whether sufficient clinical data exists. Assessing the quality, relevance, and completeness of the data, involving as required input from statisticians and clinical study experts.
- Access to a network of clinical study experts– if additional clinical data is required, assist with reviewing, planning and conducting pre (clinical investigations) and post market (post market clinical follow-up) studies.
- Robust Documentation Preparation- help prepare comprehensive and well-structured clinical evaluation. Collection and presentation of robust clinical data from the literature, supplemented with any available data for your device, providing scientific justifications, including thorough risk analysis and mitigation strategies.
In addition, we can also provide:
- Full technical documentation review/creation
- Assistance with regulatory submissions and interactions with regulatory authorities
- Training/knowledge transfer
- ISO13485 Quality Management System creation, management and support
