As per MEDDEV 2.7/1 Rev.4, Clinical Evaluation is a specialized robust method to collect, appraise and analyze clinical data related to a medical device and to interpret if there is satisfactory clinical information (evidence) to establish conformity with pertinent essential requirements for safety and performance when employing the medical device as per the manufacturer's instructions for use.
CLINICAL INVESTIGATION AND EVALUATION OF MEDICAL DEVICES AND.pptxFaizanShaikh204666
the presentation give idea about what is medical devices?
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CLINICAL INVESTIGATION AND EVALUATION OF MEDICAL DEVICES AND.pptxFaizanShaikh204666
the presentation give idea about what is medical devices?
definition's given by cdsco and usfda
what is clinical investigation in evaluation in medical devices?
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
GHTF group 1 is about pre market evaluation .This ppt includes brief about the group 1 , about ghtf , what it includes , study groups , definitions , classification and its rules
Post-Market Clinical Follow Up Studies Under EU MDR and IVDREMMAIntl
On May 5, 2017, the Active Implantable Medical Devices Directive (90/385/EEC — AIMD) and the Medical Devices Directive (93/42/EEC — MDD) were replaced by the Medical Device Regulations (MDR) 2017/745, and the In-Vitro Diagnostic Medical Devices Directive (89/79/EC — IVDD) was replaced by the In-Vitro Diagnostic Regulations (IVDR) 2017/746.
Both of these new regulations put a heavy emphasis on post-market surveillance activities for a product. Post-market clinical follow-up studies, or performance studies as called in the IVDR, are an integral part of the post-market surveillance requirements of the newly released regulations. PMCF studies must be initiated by the manufacturer...
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
GHTF group 1 is about pre market evaluation .This ppt includes brief about the group 1 , about ghtf , what it includes , study groups , definitions , classification and its rules
Post-Market Clinical Follow Up Studies Under EU MDR and IVDREMMAIntl
On May 5, 2017, the Active Implantable Medical Devices Directive (90/385/EEC — AIMD) and the Medical Devices Directive (93/42/EEC — MDD) were replaced by the Medical Device Regulations (MDR) 2017/745, and the In-Vitro Diagnostic Medical Devices Directive (89/79/EC — IVDD) was replaced by the In-Vitro Diagnostic Regulations (IVDR) 2017/746.
Both of these new regulations put a heavy emphasis on post-market surveillance activities for a product. Post-market clinical follow-up studies, or performance studies as called in the IVDR, are an integral part of the post-market surveillance requirements of the newly released regulations. PMCF studies must be initiated by the manufacturer...
Educo Life Science [gathering clinical evidence] [module 1]Ali Abu
The slide are solely prepared by Educo Life Science
Module 1 will cover the following:
Regulatory, guidance and standards for gathering medical device clinical evidence
>How does the regulation apply to gathering of clinical evidence
>What guidance and standard documents need to be followed when gathering clinical evidence
>Clinical evidence for different device classes and the procedures relative to each
>What data, when, why, and how
>Clinical definitions and terminology
A compliant CER should support strong clinical evidence that your device achieves its intended purpose without exposing users and patients to risk. The CER must be based on clinical data, which may include clinical data from existing literature, clinical experience, clinical trials, or any combination of the three.
You are required to prepare and submit a clinical evaluation report with your technical file as part of the CE Marking/conformity assessment process. However, approach the CER as a standalone document.
Clinical evaluation report cer in a more stringent regulatory- Pepgra HealthcarePEPGRA Healthcare
European regulatory framework has established rules that govern the development, manufacturing, and marketing of medical devices in the European market. Both European and non-European medical device manufacturer’s fall under the purview of the regulatory framework, which is established to
provide condence to the clinicians and the patients that the medical devices and the implantable devices used in the region have been validated for their potential benets and certied as safe for usage.
A Clinical Evaluation Plan is a critical document in the medical device regulatory process, outlining how you will gather and evaluate clinical data to demonstrate the safety and performance of your medical device. In Australia, medical devices are regulated by the Therapeutic Goods Administration. Additionally, consider consulting with regulatory experts or legal counsel experienced in medical device regulations in Australia to ensure compliance with the local regulatory framework.
https://mavenprofserv.com/clinical-evaluation-plan/
We prepare and maintain a clinical evaluation report that complies with the requirements of MEDDEV and EU MDR. Clinical evaluation report (CER) summarizes and concludes the clinical evaluation of medical devices. Clinical evaluation is responsibility of the manufacturer and is a critical step in process of CE Marking. Many manufacturers struggle and find it tedious to comply with the requirements of CER.
https://mavenprofserv.com/clinical-evaluation-report/
A Clinical Evaluation Report is a critical document required for the regulatory approval of medical devices in Australia and many other countries. It provides a comprehensive analysis of the safety and performance of the medical device based on clinical data and relevant scientific literature. Manufacturers should ensure compliance with the latest regulations set by the TGA and other relevant authorities. Additionally, consulting with regulatory experts, clinicians, and medical writers is recommended to create a robust and accurate Clinical Evaluation Report.
https://mavenprofserv.com/clinical-evaluation-report/
We prepare and maintain a clinical evaluation report that complies with the requirements of MEDDEV and EU MDR. Clinical evaluation report (CER) summarizes and concludes the clinical evaluation of medical devices. Clinical evaluation is responsibility of the manufacturer and is a critical step in process of CE Marking. Many manufacturers struggle and find it tedious to comply with the requirements of CER.
https://mavenprofserv.com/clinical-evaluation-report/
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
Where do clinical evaluation and clinical investigation intersectI3CGLOBAL
Clinical Evaluation is the process of collecting and assessing all clinical data related to a device and evaluating whether sufficient clinical evidence exists to support conformity with regulatory requirements. The clinical investigation is often the most important evidence needed to prove your medical device is ready for market.
Importance of systematic literature search for clinical evaluation (CE) the s...PEPGRA Healthcare
The Clinical Evaluation Report (CER) comprises of three major parts that present complete clinicalevaluation information of the medical device under consideration. The first section is a report of the new clinical investigations of the device conducted by the manufacturer. The second section deals with the unpublished data concerning the biological safety and bench testing of the medical device along with compliance and experience records. The third part of the CER deals with the literature review of the clinical evaluation published on equivalent devices.
Visit : www.pepgra.com
A literature review may form the major source of clinical evidence
to validate the safety and performance of the established devices
in their commercialization approval process, where it may not be
feasible to conduct new clinical investigations on the device.
POST-MARKET CLINICAL FOLLOW UP STUDIES FOR MEDICAL DEVICESSharvilModi
PMCF, or Post-Market Clinical Follow-up, is a process mandated for medical devices in the European Union. It involves collecting clinical data and feedback from real-world use after a device is launched. The objective is to assess its performance, safety, and clinical benefits. PMCF helps monitor device safety, identify any new risks or concerns, and evaluate its effectiveness. Manufacturers design a study plan, collect relevant data, analyze it, and document the findings to ensure compliance with regulations. PMCF plays a vital role in ongoing device surveillance and improving patient safety.
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2. P a g e | 2
ABSTRACT
A. CLINICAL EVALUTION and the NEED OF CLINICAL EVALUATION REPORT (CER)
key documents for your CE Cerification !!!
This write up is to enlighten the medical device manufacturers to document Clinical Evaluation
Report (CER) based on MEDDEV 2.7/1 Rev. 4 guidance. Here, it explains how an evaluation is
performed, what information is required and how this information should be appraised, analyzed
and presented in the CER.
The essentiality of an overall evaluation of the device is also highlighted with the precise focus on
establishing that clinical data are evaluated in a systematic and objective way, that the benefit
risk profile is satisfactorily acceptable and that any gaps in clinical evidence are identified and
addressed.
As per MEDDEV 2.7/1 Rev.4, Clinical Evaluation is a specialized robust method to collect, appraise
and analyze clinical data related to a medical device and to interpret if there is satisfactory
clinical information (evidence) to establish conformity with pertinent essential requirements for
safety and performance when employing the medical device as per the manufacturer's
instructions for use.
The evaluation should be based on a broad analysis of pre- and post-market clinical data relevant
to the device under evaluation as well as any data disclosing about the devices claimed as
equivalent or benchmark by the manufacturer.
The requirements of clinical evaluation are imperative to all classes of medical devices. The
evaluation should be true to the device under evaluation, its specific properties, and its intended
purpose.
Clinical evaluation is an obligation of the manufacturer and the CLINICAL EVALUATION REPORT
[CER] where all the clinical evaluation processes are documented (favorable and unfavorable),
is an essential aspect of the technical documentation for CE marking of the medical device in
accordance with the requirements shown in Article 61 and Annex XIV of Official Journal of the
European Union- Regulations (Council Regulation 2017/745 of 5 April 2017), including a PMCF*.
Clinical Evaluation Report is one of the
Here's What the Medical Device Manufacturers Need to Know!
3. P a g e | 3
* The manufacturer should take-charge of collecting clinical data of the CE marked Medical
device in-use on humans with the objective of confirming the safety and performance as
intended continuously during the expected lifetime of the device to confirm the continued
acceptability of identified risks and to detect any emerging risks based on the real and correct
clinical evidence. A PMCF plan and PMCF Evaluation Report should be maintained and when
required, preventive and/or corrective measures must be identified and the manufacturer should
implement them.
B.
B1 STAGE 0: Scoping And The Clinical Evaluation Plan
Scoping is defined based on the Essential Requirements that are vital to be addressed from a
clinical context and the type and history of the device.
The Clinical Evaluation Plan should include different aspects, considering the stages in the lifecycle
of the product.
Device description, Design features, Risk Management documents, current knowledge/ state of
the art in the corresponding medical field data source input(s) and type(s) of data to be used in
the clinical evaluation are included in all CERs whereas few aspects are specific to CERs before
and after CE marking.
VARIOUS STAGES OF CLINICAL EVALUATION
4. P a g e | 4
Before CE marking For CE marked devices
Equivalent device data **, if claimed
Any relevant changes such as:
design changes,
changes to materials and manufacturing
procedures,
changes to the information materials supplied by
the manufacturer (label, IFU, available
promotional materials including accompanying
documents possibly foreseen by the manufacturer)
or other claims,
and whether the claim of equivalence to an
existing device is still appropriate
Any specific clinical concerns that have newly
emerged and need to be addressed
PMS Data (new)
PMS Plan including PMCF
**The demonstration of equivalence should be considered based on Technical, Biological and
Clinical characteristics and the equivalence identification should be provided with proper
justification.
B2 STAGE 1: Identifion Of Pertinent Data
a) Data that are generated and held by the manufacturer :
pre-market clinical investigations
clinical data generated from risk management activities and the PMS programmes
(PMCF, Complaint reports, Incident reports and so on..)
relevant pre-clinical studies (bench test reports- verification and validation data)
b) Data derived from Literatures
Clinical data relevant to the device under evaluation or to the equivalent device (if
equivalence is claimed)
Current knowledge/ the state of the art
B3 STAGE 2: Appraisal of Pertinent Data
The evaluators should appraise each individual document identified in Stage 1 in terms of its
scientific validity, relevance, and weighting of its contribution to the evaluation of the clinical
performance and safety of the device.
5. P a g e | 5
"The clinical evaluation report and the
evidence for conformity assessment"
B4 STAGE 3: Analysis Of The Data, whereby conclusions are reached about
in concurrence with Essential Requirements (including ER1, ER3, ER6) on performance
and safety of the device, including its benefit-risk profile,
the contents of information and materials given by the manufacturer (including the
IFU, Iabels of the device, promotional materials, including accompanying documents
possibly aniticipated by the manufacturer),
residual risks and uncertainties or unanswered questions (including on rare
complications, long-term performance, safety under widespread use), whether these
are acceptable for CE-marking, and whether they are required to be addressed
during PMS.
B5 STAGE 4: Clinical Evaluation Report (CER)
Clinical Evaluation report (CER) has the summary and inferences of the evaluation of all the
relevant clinical data documented or referenced in other parts of the Technical File
documentation.
relevant clinical data constitute the clinical
Clinical Evaluation is a paramount aspect of CE Mark certification process because it guarantees
that the evaluation of safety and performance of the device is based on adequate clinical
evidence throughout the lifetime that the medical device is on the market.
This continuous process enables manufacturers to handover the notified bodies and competent
authorities with sufficient clinical evidence for the demonstration of conformity of the device with
the Essential Requirements throughout its lifetime (for example: for CE marking, completion of post-
market surveillance and reporting necessities, or during surveillance processes).
6. P a g e | 6
C1. Clinical Evaluation During the Development of A Medical Device
“The Clinical Evaluation Report is essential for initial CE-
marking and it must be actively updated since that time
onwards. It is conducted during the whole of the life cycle of
a medical device, as a continuous process”
Mostly, clinical evaluation is first performed during the development of a medical device in order
to:
a) Interpret needs regarding clinical safety and clinical performance of the device -
sufficient clinical evidence to establish conformity with the Essential Requirements
covering clinical performance and clinical safety;
b) Determine what data need to be generated for European market entry by carrying
out a gap analysis - Post-market Surveillance (PMS), E.g. in post-market clinical follow-
up studies (PMCF Studies) required under the medical device directives [MEDDEV
2.12/2 ]. Generally, these aspects include estimation of residual risks and uncertainties
or unanswered questions (such as rare complications, uncertainties regarding long-
term performance, safety under wide-spread use) [EN ISO 14971:2012];
c) Find out whether clinical investigations are necessary and if so, to define the study
design [EN ISO 14155:2011]
d) Decide desirable equivalence to an existing device thorough available clinical data
RIGHT TIME FOR CLINICAL EVALUATIONC.
7. P a g e | 7
The manufacturer should specify and substantiate the frequency at which the clinical evaluation
needs to be actively updated.
The clinical evaluation should be actively updated:
1. When the manufacturer collects new information from PMS that has the potential to
change the current evaluation. As a manufacturer, one should establish a PMS system
with a well-defined scope and nature in line with the inteded pupose of the device
that consistently monitors the clinical performance and clinical safety of the device
as part of their quality management system. PMS should systematically generate new
data, such as safety reports, results from published literatures, registries, PMCF studies,
and other data about device usage. Those data need to be evaluated for
information that has a potential to change the evaluation of the benefit-risk profile,
and the clinical performance and clinical safety of the device. These data are
required to be fed into the clinical evaluation files in a timely manner. In agreement
with the Regulatory Directives, the clinical evaluation and the clinical evaluation
report must be actively updated with data obtained from post-market surveillance.
2. If no such information is received, then CER should be updated:
at least annually if the device carries serious risks or is not yet well established; or
every 2-5 years, if the device is not expected to transmit serious risks and is well
established, a justification should be provided.
When involvement of notified bodies is required, updates are usually coordinated with the notified
body. Usually, they are lined up with the timetable for surveillance audits and the renewal of the
certificates.
C2. Updating the Clinical Evaluation Report
"Clinical Evaluation can therefore lead to changes to the
Manufacturer's Risk Management Documents, Instructions
For Use (IFU) and PMS Activities ".
8. P a g e | 8
Clinical evaluation should be conducted by a well-qualified individual or a team and the
evaluator(s) should own experience and expertise in research methodology, information
management, regulatory requirements, medical writing, proficiency of the technology of device
under evaluation and its application, diagnosis and management of the conditions intended to
be diagnosed or managed by the device, familiarity of medical alternatives, medical care
standards and technology (e.g. specialist clinical expertise in the relevant medical specialty).
In cases where the level of evaluator expertise may be less or different, it should be recorded and
properly justified.
"DECLARATION OF INTEREST and CURRICULUM VITAE" of the
ROLE OF CLINICAL EVALUATOR(S) Few Points to Note !D.
EVALUATOR(S) must be submitted with Clinical Evaluation
Files to the Notified Body.
“The evaluator(s) should have 5-10 years of documented
professional experience in the relevant field”.
9. P a g e | 9
WHAT THE NOTIFIED BODY WOULD CHECK FROM THE MANUFACTURER'S CLINICAL
EVALUATION REPORT!
E.
device description and product specification
intended purpose of the device
classification proposed for the device
pre-clinical evaluation data presented by
the manufacturer
risk analysis and risk management and
alignment with the clinical evaluation report
clinical evaluation process
clinical evaluation report’s authors
equivalence assessment – if data from equivalent is used
clinical investigation plans and reports etc.
F.
a new CER with well tailored SOPs and templates for each stages
updating your existing CER
upgrading your CER to comply with the latest regulatory requirements [MDD
superseded by MDR ]
assisting and training QA/RA team in your organization effectively to conduct Clinical
evaluation, including PMS, PMCF, Risk Management Files and so on.
1. MEDDEV 2.7/1 Revision 4. Clinical Evaluation: A Guide for Manufacturers and Notified
Bodies Under Directives 93/42/EEC and 90/385/EEC,2016
2. Official Journal of the European Union- Regulations (Council Regulation 2017/745 of 5
April 2017)
G. REFERENCES
I 3 CONSULTING HELPS WITH EFFICIENT PREPARATION (BUT NOT LIMITED):
10. P a g e | 10
We are a group of qualified and experienced Regulatory Affairs Specialists(Consultants) for Highly
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I.
The author would like to thank Mr. Soio George, Lead Auditor and Project Head (Medical Device
EU & USFDA Regulatory Compliance) I 3 Consulting, India for his guidance in preparing this article.
J.
Ms. Asha Meria Johnson B. Tech, MS, is a senior medical device regulatory consultant and Team
Lead for Clinical Evaluation as per new MEDDEV 2.7/1 Rev. 4. She received her graduation from
University of Calicut, India, and post-graduation from NJIT, USA. Ms. Asha was completely
engaged from the day of the release of MEDDEV 2.7/1 Rev. 4 in developing a practical approach
plan towards submission of the Clinical Evaluation Report (CER) to various Notified Bodies on
behalf customers across the globe. Her hard work and efforts have achieved the results; today
the team under her guidance and supervision has submitted successfully more than 35 CERs to
various Notified Bodies. Readers may contact her at aj@i3cglobal.com
75 Executive Drive, Suite 303, Aurora, Illinois, USA 60504. Telephone +1 630 696 1293
S8,JJPark,4Cross,S.GPalya, DRCPost,Bangalore, INDIA560029. Telephone+919945912081
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ABOUT I 3 CONSULTINGH.
ACKNOWLEDGEMENTS
AUTHOR