Justification of a Manufacturer’s decision to perform or not PMCF studies is a trigger of uncertainty when building up a MDR-compliant Technical Documentation. Evnia has brought together the most important aspects to consider!
1. Equivalence: Is your medical device marketed based on equivalence?
2. Device Description: Is your device ‘novel’ with respect to design, components, used substances, mode of action?
3. Significant Changes: Have there been ‘significant’ changes as per EU-MDR to your device’s design and/or intended use?
4. Labelling:
a. Is there ‘sufficient’ clinical evidence to support your device’s indications?
b. Have you identified higher/increased risk(s) in specific populations (e.g. elderly, children, patients with a specific comorbidity) that would require further investigation to establish a positive benefit-risk ratio?
c. Does the real-world use of your device continue to support the contra-indications statement?
5. Clinical Claims: Are the clinical claims of safety and performance, made for your device, sufficiently supported by clinical evidence?
6. Post-market Surveillance:
a. Have there been new data on the safety and performance of your device in the literature?
b. Have there been new adverse events reported not included in your Risk Management report?
c. Does the clinical evidence on your device support its continued market acceptance?
7. Expected Lifetime: Is the full expected lifetime of your device ‘covered’ with safety and performance clinical evidence?
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