The MEDDEV 2.7/1 Rev 4 guidelines, released in June 2016, provide updated guidance on clinical evaluation in Europe to the medical device manufacturers and notified bodies under directives 93/42/EEC and 90/385/EEC. The latest revision (Rev 4) effectively replaces Rev 3 published in December 2009. While the ideology of evaluating clinical evidence to demonstrate compliance with relevant Essential Requirements remains unchanged, the Rev 4 guidelines detail the requirement for clinical evaluation. This short communication highlights the four key changes in Rev 4 guidelines pertaining to clinical evaluation and provides Indegene’s perspective and expertise on clinical evaluation reports (CERs) meeting Rev 4 requirements. KEY CHANGES IN MEDDEV 2.7/1 REV 4 GUIDELINES Perspectives in Addressing These Changes
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KEY CHANGES IN MEDDEV 2.7/1 REV 4 GUIDELINES · PDF fileThe MEDDEV 2.7/1 Rev 4 guidelines, released in June 2016, provide updated guidance on clinical evaluation in Europe to the medical
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The MEDDEV 2.7/1 Rev 4 guidelines,
released in June 2016, provide
updated guidance on clinical
evaluation in Europe to the medical
device manufacturers and noti�ed
bodies under directives 93/42/EEC
and 90/385/EEC. The latest revision
(Rev 4) e�ectively replaces Rev 3
published in December 2009. While
the ideology of evaluating clinical
evidence to demonstrate compliance
with relevant Essential Requirements
remains unchanged, the Rev 4
guidelines detail the requirement for
clinical evaluation. This short
communication highlights the four
key changes in Rev 4 guidelines
pertaining to clinical evaluation and
provides Indegene’s perspective and
expertise on clinical evaluation
reports (CERs) meeting Rev 4
requirements.
KEY CHANGES IN MEDDEV 2.7/1 REV 4 GUIDELINESPerspectives in Addressing These Changes
INDEGENE PERSPECTIVE
[email protected] E W www.indegene.com +1 732 750 2901P +1 732 750 7990FIndegene, 485B Route 1 South, Suite 300, Iselin, NJ 08830.
State-of-the-Art
In the process of
identifying
state-of-the-art in the
corresponding medical
�eld, the Rev 4
mandates for a detailed
evaluation of current
treatment landscape,
safety, and performance
of subject device,
equivalent device, or
benchmark device, as
well as assessment of
bene�t-risk pro�les of
alternative therapies
available to the target
patient population.
Noti�ed bodies have already started expecting CERs in compliance with Rev 4 guidelines. Subject matter expertise
across therapy areas is essential to perform clinical evaluation in a robust manner and to address the key changes
discussed above. Further, collaboration is required among the clinical, quality, and regulatory divisions of medical
device companies to conduct extensive gap analysis comparing the Rev 3 and Rev 4 guidelines, and improvise the