February 2024 SOCRA Source Journal - Journal - Page 69
TABLE 6:
KEY MDR REQUIREMENTS
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Clinical evaluation for every device irrespective of class
Clinical trial for Class III implants and active implantable medical devices
Thorough state-of-the-art literature review, including:
◦ Search criteria
◦ Inclusion/exclusion criteria
Comparison to substantially equivalent device(s)
Justification of the applicability on non-CE marked devices to European use
Substantial equivalency based on:
◦ Similar intended purpose
◦ Key technical/biological characteristics
literature review that includes
the search criteria and the
inclusion and exclusion criteria
used is required.
In Europe, CE-marked devices
are preferred. For non-CE
marked devices, a justification
of the applicability to European
use is required. Comparison
to a substantially equivalent
device(s) is required. Substantial
equivalency must be based
upon a similar intended
purpose and key technical and
biological characteristics.
The MDR outlines criteria under
which a clinical trial might
not be necessary (Chapter VI:
Clinical Evaluation and Clinical
Investigations). Class III devices
and all active implantable
medical devices require clinical
investigations, except if:
• the device is a design
iteration by the same
manufacturer,
• the new device is
substantially equivalent to
the earlier version, or
• the CER shows safety and
performance.
To avoid having to conduct
a clinical trial, the device
manufacturer must have a
contract with the predicate
device manufacturer for
continued access to primary
clinical data and post-marketing
surveillance data. Realistically,
this means that significant
equivalence for high-risk
products can only be used
for products by the same
manufacturer.
The MDR chapter on clinical
evaluation and clinical
investigations states that a
clinical evaluation “shall follow
a defined and methodologically
sound procedure based on the
following:
a. a critical evaluation of the
relevant scientific literature
currently available relating
to the safety, performance,
design characteristics and
intended purpose of the
device, where the following
conditions are satisfied:
◦ it is demonstrated that
the device subject to
clinical evaluation for
the intended purpose is
equivalent to the device
to which the data relate,
in accordance with
Section 3 of Annex XIV,
and
◦ the data adequately
demonstrate compliance
with the relevant general
safety and performance
requirements;
b. critical evaluation of the
results of all available clinical
investigations, taking duly
into consideration whether
the investigations were
performed under Articles
62 to 80, any acts adopted
pursuant to Article 81, and
Annex XV; and
c. a consideration of currently
available alternative
treatment options for that
purpose, if any.”
“A consideration of currently
available alternative treatment
options for that purpose, if
any” is a new requirement in
the MDR. The CER should have
a state-of-the-art description
and disclosure of alternative
procedures and analysis of the
relevance of the procedure used
for the device under evaluation.
Clinical Evidence Guidance in
the MEDDEV 2.7/1 Revision 4
requires the following:
SOCRA SOURCE © May 2023
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