Section E — Clinical investigations and related documentation

Source: MDCG-2020-01.pdf pages 19-20 (document: MDCG 2020-13)

Non-compliances identified and resolved for this section may be briefly described in this box

Data appraisal is: Compliant with the applicable requirements of the MDR: - [ ] Include any relevant comments Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: - [ ] Add a clear description of any remaining minor non-compliance together with required follow-up actions to close them and timelines for their completion to be followed by the manufacturer.

Section E: Clinical investigations and related documentation

Has the manufacturer conducted clinical investigation(s)? State Yes / No

Has the manufacturer conducted pre-market or post-market clinical investigations? Provide detail

If the manufacturer has not conducted clinical investigation: What is the rationale? Why is this acceptable / unacceptable?

Has the manufacturer provided a copy of all clinical investigation reports? State Yes / No

Were all clinical investigations publicly registered? State Yes / No

Have been verified that clinical investigations conducted with respect to Regulation (EU) 745/2017 publicly registered on EUDAMED? State Yes / No Provide the EUDAMED single registration number where available.

Did the clinical investigations result in a publication in a scientific journal? State Yes / No If yes, does the clinical investigation report reflect the results of clinical investigation(s) or other studies reported in scientific literature, or reports published in peer reviewed scientific literature on other clinical experience? If there are any differences describe these and summarise the rationale provided by the manufacturer.

Has the manufacturer provided all Competent/Regulatory Authority correspondence (from all countries, including outside of EU) State Yes / No

Are the conclusions drawn by the manufacturer, based upon the results of the clinical investigation, valid in the light of the approved clinical investigation plan? Provide detail

If clinical investigations not performed under Regulation (EU) 745/2017 were not publicly registered or published:

• Confirm that a rationale was provided.
• Confirm that the SSCP and where relevant the IFU (for example with respect to the description of clinical benefits) adequately provide information for the intended user and if relevant, the patient.

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Clinical Investigation Plan (CIP) reference

CIP complies with MDR, Annex XV, and EN ISO 14155 Annex A State Yes / No

CIP scope and study design

Adequacy of CIP scope and study design for demonstration of safety, performance and benefit risk of subject devices:

• Study design.
• Devices identified.
• Patient population.
• Patient numbers.
• Objectives and endpoints.
• Length of follow up and intervals.
• Study locations.
• Overall conclusions.

Non-compliances identified and resolved for this section may be briefly described in this box