Essentials of European Medical Device Regulatory Affairs

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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