Medical Device
Medical Device Coordination Group Document MDCG 2024-3
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geographic distribution of the intended patient or user populations. Discuss the
impact and account for any local adaptations.
• Describe whether patients were or will be involved during the different phases of the
clinical investigation, e.g. involvement in determining the objectives, assessing the
burden of study participation for subjects or dissemination of the results.
3.6.4. Details of measures to be taken to minimise bias, such as
randomisation, and management of potential confounding factors.
• Describe measures taken to minimize bias or avoid bias, such as randomization,
concealment of allocation, blinding/masking, and management of potential confounding
factors. Use of either single arm or (choice of) comparator or other (historically) controlled
design and the concept of blinding and unblinding, or running open label need to be
covered, with rationale and justification.
• Sham procedures (if any) need to be thoroughly justified, in particular if the procedures
are invasive or burdensome, as exposing subjects to risk without the potential benefit of
the device/intervention may be questionable from an ethical perspective.
• Be transparent about any potential conflicts of interest, and if they are present, how these
shall be managed. In particular, it needs to be discussed how undue influence on
subjects and evaluation of endpoints can be avoided, for example in situations where the
device inventors are closely involved in the conduct of the investigation. To avoid bias in
certain assessments an independent committee may be used to determine eligibility,
classification of events, endpoint adjudication etc. (clinical events committee (CEC)).
• Further a data safety monitoring board (DSMB) or data monitoring committee (DMC)
should be considered, and in appropriate situations, appointed to continuously monitor
the emerging clinical investigation results and advice on the termination or progression
of the study.
• If the clinical investigation involves a blinding/ masking technique, include criteria for who
will get access to and is authorised to break the blinding/masking code, and the
circumstances when this would occur.
3.6.5. Description of the clinical procedures and diagnostic methods relating
to the clinical investigation and in particular highlighting any deviation
from normal clinical practice.
• Describe all the clinical investigation -related procedures and diagnostic methods used
in the clinical investigation. Any deviation from normal clinical practice should be
highlighted. A tabular overview/schedule of events may be helpful to summarise the
activities by visit, but it also needs to be clearly presented in detail what will have to be
performed at which visit, in which order, how and by whom.
• The number of medical devices and comparators (if applicable) used per subject, and
procedures to ensure safe use of the device need to be described, in particular in
situations where the same device is used for several subjects.
• Methods and timing for assessing, recording, and analysing variables (such as adverse
events, symptoms, parameters and/or results to be studied), including details on the
equipment to be used for assessing the clinical investigation variables and arrangements
for monitoring the maintenance and calibration of such equipment.
• Specify which biological samples are collected for the purpose of the clinical
investigation, if any, and describe the arrangements to comply with the applicable rules
for the collection, storage and future use of biological samples.