Essentials of European Medical Device Regulatory Affairs - October 2019
Life Cycle Clinical Evaluation
Post Launch Activities
Concept
Feasibility
Development
Launch
Prototype development Bench and pre‐clinical
Initial clinical evaluation ‒ Literature review ‒ Initial clinical investigations Human factors
Clinical investigations to support CE mark User testing
Obtain CE Mark
Post marketing surveillance Real life studies to support ‒ Reimbursement ‒ Marketing
Studies on non CE marked products
Studies on CE marked products
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Clinical Evaluation : Article 61
Conformity to the general safety and performance requirements (Annex I) is based on clinical data to show Annex I. (1). device performance, acceptable benefit/risk Annex I. (8). any foreseeable risks and minimising undesirable side effects Provide necessary labelling information required in Annex III.
The level of clinical evidence required should be appropriate to the device and its intended performance.
a clinical evaluation is required for all devices.
The requirement for a clinical evaluation report is not new. (MDD Essential requirement 6a.)
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