“…let me just transfer all this device information from the Clinical Evaluation Plan to the Clinical Evaluation Report template. Quite a few sections are the same.” Sounds familiar?
The arrival of the EU MDR and IVDR introduced new reporting requirements for medical device manufacturers. If you’re a part of a team authoring regulatory documents for the EU MDR/IVDR, terms like the CEP, CER, CPR, APR, SVR, PEP, PER, PMSR, PSUR, SSCP and PMCF must be familiar to you.
And once you’ve authored multiple reports (for MDR or IVDR), you will realize that quite a few of the sections between these reports are just about the same. Did you ever wonder, “Why can I not leverage the same section for another report?” Well, we did which gave rise to our Data Dictionary feature in CAPTIS™.
There are often multiple report documents that must be created for the same medical device/device family per the EU MDR/IVDR Requirements. A few of these MDR and IVDR reports include:
- Clinical Evaluation Plans (CEP)
- Clinical Evaluation Report (CER)
- Clinical Performance Report (CPR)
- Analytical Performance Report (APR)
- Scientific Validity Report (SVR)
- Performance Evaluation Plan (PEP)
- Performance Evaluation Report (PER)
- Post-Market Surveillance (PMS) Plan
- Post-Market Surveillance Reports (PMSR)
- Periodic Safety Update Report (PSUR)
- Summary of Safety and Clinical Performance (SSCP)/Summary of Safety and Performance (SSP)
- Post-Market Clinical Follow-up (PMCF) Plan/Post-Market Performance Follow-up (PMPF) Plan
- Post-Market Clinical Follow-up (PMCF) Report/Post-Market Performance Follow-up (PMPF) Report
While the bulk of the report content remains unique across these reports, there are certain sections and blocks of information which remain the same and are repeated throughout. For example:
- Device Description
- Product Formulation/Material Composition
- Principle of Operation/Mode of Action
- Intended Use of the Medical Device
- List of part numbers/SKUs in scope of the Report
- Manufacturer Details
- Regulatory Information on the Device
- Market History
- Safety and Performance Claims
- Year of Launch
- Year of CE mark approval
- Technical File Number
Additionally, these reports may have information which is presented at multiple instances within the same report – the date range, overall complaints rate, sales numbers, number of hits from literature, the number of included articles, and the number of reported adverse events, to name a few.