Item 6: PMCF Plan

Deficiency

Compliance to PMCF requirements in Annex XIV 5, 6.1 and 6.2 has not been demonstrated.

Requirements and references

• Annex XIV (5)
• Annex XIV (6.1) and (6.2)
• MDCG 2020-7

MDF reference

MDF4550 §3.3.2

Context

Requirements

• Annex XIV (5) PMCF shall be understood to be a continuous process that updates the clinical evaluation referred to in Article 61 and Part A of this Annex and shall be addressed in the manufacturer's post-market surveillance plan. When conducting PMCF, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which bears the CE marking and is placed on the market or put into service within its intended purpose as referred to in the relevant conformity assessment procedure, with the aim of confirming the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence
• Annex XIV (6.1 and 6.2)

Guidance

• MDCG 2020-7

Observations

There seems to be many specific PMCF studies planned. Overall justification that the PMCF plan is expected to collect sufficient data in quality and quantity to confirm the benefit, safety, and performance of the device over its lifetime based on all activities is not found.

As it pertains to the specific activities, the following is unclear:

• Justification/rationale for all of the activities (several seem to be collecting data on teledermatology, which does not seem to be a feature of this device, also see question 2)
• Sufficient detail on each activity (methods, sample size for each and justification, acceptance criteria, timelines, etc) and justification of methods
• All studies seem to say they will be conducted on Legit.Health. It is unclear if this should instead say Legit.Health.Plus
• An evaluation of the clinical data relating to the equivalent or similar devices is not found.