February 2024 SOCRA Source Journal - Journal - Page 63
JOURNAL ARTICLES
Developing and Maintaining
Global Clinical Evaluation
Reports: Best Practices and
Impact of the Medical Device
Regulation and the In Vitro
Diagnostics Regulation
Luis Jimenez, RAC
Vice President of Business Development
PharmaLex
Heyam Kalla
Associate Director, Team Lead Medical Devices / IVD
PharmaLex MedTech
Abstract: As Europe transitions to the Medical Device Regulation and the In Vitro Diagnostics Regulation
while Asia Pacific regulators, including Australia’s Therapeutic Goods Administration, focus more on
clinical evidence, creating a Clinical Evaluation Report that meets the expectations of international
regulators is becoming increasingly complex. This article reviews the MEDDEV 2.7/1 Revision 4
requirements, with an emphasis on strategies to meet the individual requirements of specific regulators
in one document. Key guidance on navigating the world of Clinical Evaluation Reports and the MEDDEV
2.7/1 Revision 4 are shared. Areas of focus for device manufacturers and sponsors, based upon recent
feedback from European Notified Bodies and Therapeutic Goods Administration review, are also covered.
INTRODUCTION TO CLINICAL
EVALUATION REPORTS
The objective of a Clinical
Evaluation Report (CER) is to
demonstrate that a device
achieves its intended purpose
without exposing users and
patients to further risk (Table
1). Risk is a core part of the
equation. Aside from a clinical
trial, the CER is highest in
the hierarchy in evaluating
whether the clinical outcomes
are sufficiently beneficial when
considering the risk to a patient
undergoing a procedure and
using a device.
The three key areas of focus in a
CER are clinical trials, literature,
and post-market data. All of this
data must be summarized in a
concise document. The CER is
the assessment and analysis of
all clinical data pertaining to a
medical device.
The backbone of a CER is the
Medical Device Regulation
(MDR) and MEDDEV 2.7/1
Revision 4. MEDDEV
recommends the following
stages:
• Stage 0: Scope and plan
• Stage 1: Identify pertinent
data
•
•
•
Stage 2: Appraisal of data
Stage 3: Analysis of data
Stage 4: CER
The CER must be carefully
planned and documented.
MEDDEV 2.7/1 Revision 4
specifies that the frequency
for updating the CER needs to
be defined and justified. The
CER should be updated, for
example, when new information
from post-market surveillance is
received that has the potential
to affect the CER. If no new
information is received, then the
CER must be updated at least
annually if the product has a
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