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CLINICALEVALUATION
&
POST-MARKETCLINICAL
FOLLOW-UP(PMCF)
MEDICAL DEVICES REGULATION (MDR) 2017/745
CHAPTER VI, Article 61
...
PAGE 2
CLINICAL EVALUATION
• General safety and performance
requirements
• Evaluation of side effects
• Benefit risk ratio...
PAGE 3
CONSULTING EXPERT PANEL
• Class III and IIb devices
• Manufacturer can consult an
expert panel to review its strate...
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