Clinical Evaluation Procedure
Build and maintain a medical device clinical evaluation under Regulation (EU) 2017/745 (EU MDR). This editable procedure takes your team from planning and evidence search through appraisal, analysis and the Clinical Evaluation Report (CER).
Building a set? Buy procedures from the same family together and save: 5–9 for 20% off, 10–19 for 35%, 20–39 for 50%, or 40+ for 60%. The discount is applied automatically in your cart, or use Build Your QMS to choose and price a set.
Included: clinical evaluation procedure and instructive CER report document
The Clinical Evaluation Procedure with an instructive CER report document, including guidance for each section, as an attachment. Supplied as one editable Microsoft Word document in a digital download. Review the document previews above before purchasing.
What the procedure covers
Defining the scope and objectives of the clinical evaluation.
Identifying pertinent clinical data and conducting literature reviews.
Appraising the relevance and quality of available evidence.
Analyzing clinical data and documenting conclusions in the CER.
Incorporating new evidence from PMS and PMCF into the continuing evaluation.
Connecting clinical conclusions with risk management and the continuing benefit-risk assessment.
When to choose this procedure
Choose this product when your team needs a process for preparing and maintaining the clinical evaluation and CER. Clinical evaluation continues as new information becomes available from literature, clinical investigations, PMS and PMCF. Adapt the documents to your device, intended purpose, available evidence and responsibilities.
Connect the clinical evidence workflow
Post-Market Clinical Follow-Up Plan: define future clinical follow-up activities, methods and timing.
PMCF Evaluation Report: evaluate findings from completed follow-up activities.
Post Market Surveillance Procedure: connect broader post-market information with the continuing evaluation.
These linked products are sold separately; the dedicated PMCF Plan and PMCF Evaluation Report are available in the bundle below.
Individual procedure or bundle?
This Clinical Evaluation Procedure is $149 and includes the instructive CER report document described above. For the five connected products covering clinical evaluation, PMCF planning and reporting, PMS and clinical investigation, compare the Clinical Evaluation Procedure Bundle. Review its contents before purchasing individual products to avoid duplicate purchases.
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read Clinical Evaluation Reports: Turning Medical Device Evidence into Conclusions for workflow guidance, a checklist and common mistakes.
