This presentation provides a detailed overview of Clinical Evaluation for medical devices under EU MDR 2017/745. It explains what clinical evaluation is, why it is mandatory for all device classes, and how manufacturers must systematically collect, appraise, and analyze clinical data to demonstrate safety, performance, and clinical benefit. The presentation covers key MDR clinical evaluation components including the Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), demonstration of equivalence, literature search protocol and report, and benefit risk assessment in line with General Safety and Performance Requirements (GSPR). It also highlights regulatory expectations for CE marking, technical documentation, and ongoing clinical evaluation throughout the device lifecycle. For expert support in MDR clinical evaluation and CER writing, contact [email protected] or visit www.mavenprofserv.com
Clinical Evaluation for Medical Devices Under EU MDR 2017745
Clinical Evaluation for
Medical Devices Under EU
MDR 2017/745
www.mavenprofserv.c
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What is Clinical
Evaluation?
• Clinical Evaluation is a systematic and ongoing process
• It collects, appraises, and analyzes clinical data related to a
medical device
• Purpose is to confirm:
1.Safety
2.Performance
3.Clinical benefit
• Evaluation is performed according to the manufacturer’s
Instructions for Use (IFU)
Why is Clinical Evaluation
• Mandatory requireImenpt ounrdtear EnUt M?DR 2017/745
• Applies to all classes of medical devices
• Supports:
1.CE Marking approval
2.Risk–benefit acceptability
3.Market access in the EU
• Demonstrates compliance with General Safety and
Performance Requirements (GSPR)
SCOPE OF CLINICAL
EVALUATION
• Evaluation is device-specific and based on:
1.Intended purpose
2.Target patient population
3.Clinical indications
• Assessment includes:
1.Benefits vs. risks
2.Nature, probability, duration, and frequency of
risks
3.Based on current state of the art and scientific
knowledge
CLINICAL EVALUATION
PLAN (CEP)
• Defines how the clinical evaluation will be
conducted
• Includes:
⚬ Evaluation objectives
⚬ Clinical data sources
⚬ Methods of analysis
⚬ Criteria for data appraisal
• Forms the foundation of the Clinical Evaluation
process
CLINICAL EVALUATION
• Core documeRntE dPemOoRnsTtr a(tCinEg:R)
⚬ Safety
⚬ Performance
⚬ Clinical effectiveness
• Includes:
⚬ Clinical investigation data (if applicable)
⚬ Scientific literature
⚬ Technical and PMS data
• Confirms compliance with MDR clinical evaluation
requirements
DEMONSTRATION OF
EQUIVALENCE
• Allows use of clinical data from an equivalent device
• Equivalence must be shown in:
⚬ Technical characteristics
⚬ Biological characteristics
⚬ Clinical characteristics
• Reduces need for new clinical investigations while
maintaining compliance
LITERATURE SEARCH PROTOCOL
& REPORT
• Literature Search Protocol
• Defines search strategy, keywords, databases, and
inclusion criteria
• Literature Search Report
• Summarizes safety and performance evidence
• Documents evaluator conclusions
• Supports clinical claims and benefit-risk assessment
CLINICAL EVALUATION UNDER MDR
• Integral part of 2MD0R1 Te7ch/n7ic4al5 Documentation
• Must:
⚬ Provide evidence for relevant GSPRs
⚬ Assess undesirable side effects
⚬ Justify adequacy of clinical evidence
• A well-prepared CER ensures:
⚬ Regulatory compliance
⚬ Audit readiness
⚬ Successful CE Marking
CONTACT
+9U1S-
ENQUIRY@MA7V4E9N0P0R1O7F7S7E
WWW.RMVA.CVOEMNP4ROFSE
RV.COM
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