- Published
- Updated
- Sources checked
A clinical evaluation becomes reviewable when each intended purpose and clinical claim has a visible evidence chain.
MDR clinical evaluation — Define the regulatory scope
MDR Article 61 and Annex XIV govern clinical evaluation. MDCG assessment guidance helps structure a review but does not supply missing device evidence.
MDR clinical evaluation — Build the working record
Build a matrix linking intended population, indication, claimed benefit, safety question and relevant evidence. Record study relevance, limitations and residual gaps instead of counting publications as if they had equal weight.
MDR clinical evaluation — Check before release
- Match evidence to the actual device variant.
- Compare outcomes with the current state of the art.
- Record unresolved benefit-risk questions explicitly.
MDR clinical evaluation — Record the decision and handover
Approve a conclusion for each claim and assign the next evidence action. Where support is insufficient, consider further evaluation or narrowing the claim; a polished report cannot repair an unsupported intended purpose.
Frequently asked questions
- Is a literature list a clinical evaluation?
- No. Evidence must be critically appraised and connected to device safety, performance and benefit.
- Does CE marking end clinical evaluation?
- No. Clinical evaluation is maintained across the device lifecycle.