Module 16 2022
9/2/2022
Post Market Surveillance and Vigilance
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© NAMSA 2021
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CLINICAL EVALUATION PLAN & CLINICAL DEVELOPMENT PLAN Annex XIV, 1(a)
INPUTS
OUTPUTS
EQUIVALENCE Article 61, 3(a)
STATE OF THE ART Annex I, GSPR’s 1, 4
Literature Searches
Continuous
CLINICAL INVESTIGATIONS Article 61,3(b)
BENEFIT / RISK Annex I, GSPR’s 1, 5, 6, 8
IFU Annex I, GSPR 23
ALTERNATIVE TREATMENTS Article 61, 3(c) PRE-CLINICAL STUDIES Annex II, 6.1(a) COMMON SPECIFICATIONS Article 9
CLINICAL EVALUATION (Article 61, Annex XIV Part A)
SSCP Article 32, Implant/Class III
IMPLANT CARD Article 18, Implantable
Lifetime
RISK MANAGEMENT Annex I, GSPR 3, 4
PMSR / PSUR Article 85 / 86
FEEDBACK SYSTEMS
POST-MARKET CLINICAL FOLLOW-UP PLAN Annex XIV, Part B, 6 / MDCG 2020-7
POST-MARKET SURVEILLANCE PLAN Article 84
POST-MARKET SURVEILLANCE Article 83, Annex III Feedback, Complaints, Vigilance (Article 87), Trending (Article 88), PMCF Report (Annex XIV, Part B) / MDCG 2020-8
Feedback
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