Module 15 2022

19/05/2022

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)

CLINICAL EVALUATION (Article 61, Annex XIV Part A)

SSCP Article 32, Implant/Class III

PRE-CLINICAL STUDIES Annex II, 6.1(a)

IMPLANT CARD Article 18, Implantable

COMMON SPECIFICATIONS Article 9

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

The Organisation for Professionals in Regulatory Affairs

5

Re-cap of the clinical evaluation process

• Article 2 (48) provides the definition for clinical data: • ‘clinical data’ means information concerning safety or performance that is generated from the use of a device and is sourced from the following: – clinical investigation(s) of the device concerned,

– clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated, – reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated, – clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up ;

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

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