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/

1. CLINICAL EVALUATION
PLAN

2. Content
Clinical Evaluation Plan
Requirements of MDR 2017/745 Annex XIV
part A
MEDDEV 2.7/1 rev 4 requirements before
CE marking
MEDDEV 2.7/1 rev 4 requirements after CE
marking

3. Clinical Evaluation Plan
A clinical evaluation plan is a strategic plan that defines the
clinical evaluation process required by MEDDEV 2.7/1 rev 4
and EU MDR article 61 and Annex XIV Part A. The clinical
evaluation plan acts as planning document for your clinical
evaluation and all the activities of Clinical Evaluation are
carried out as per the Clinical Evaluation Plan.
Both MEDDEV 2.7/1 rev 4 and MDR 2017/745 Annex XIV
part A provides more details on the requirement of the
clinical evaluation plan

4. Requirements of MDR 2017/745 Annex XIV
part A
Identification of GSPR that require relevant clinical data.
Specification of the intended purpose.
Specification of intended target groups with clear indications
and contra-indications.
Description of intended clinical benefits to patients.

5. Specification of methods to be used for examination of
qualitative and quantitative aspects of clinical safety with
clear reference to the determination of residual risks and
side-effects.
An indication and specific parameters used to determine
the acceptability of the benefit-risk ratio for the various
indications and for the intended purpose or purposes of the
device based on the state of the art in medicine.
Indication of risk-benefit ratio if any animal or human tissue
or pharmaceutical components are present.

6. MEDDEV 2.7/1 rev 4 requirements before
CE marking
Device description.
Intended purpose, Target group, an indication and should
also cover any design features that pose special
performance or safety concerns (e.g. presence of
medicinal, human, or animal components), the intended
purpose and application of the device (e.g. target treatment
group and disease, proposed warnings, contraindications,
precautions, and method of application.

7. Claims made by the manufacturer about the clinical
performance and clinical safety of the device.
Information needed for evaluation of equivalence.
Risk data such as hazard identification list, clinical risk
identified from risk analysis. Clinical evaluation should
address the significance of any clinical risks that remain
after design risk mitigation strategies.
The current state of the art in the corresponding medical
fields such as applicable standard and another guidance
document, information on other devices such as benchmark
devices or other medical alternatives treating a same
medical condition.

8. MEDDEV 2.7/1 rev 4 requirements after CE
marking
Important changes in design, materials, or manufacturing
procedures, the information supplied by the
manufacturer or other claims or claims of equivalence of
existing device is still appropriate.
If any specific clinical concerns have newly emerged and
need to be addressed.

9. PMS data updated in CER with new clinical data for the device
under evaluation or equivalent device, new knowledge about
potential hazards, risks, performance, benefits, claims.
Need for PMS planning activities.
MAVEN – the perfect solution for your clinical evaluation plan.
You can write to us for clinical writing of your CEP and CER or
simply buy our clinical evaluation plan templates from the
webiste that cover all the requirements of clinical evaluation plan
as per global standards.

10. Contact Us
https://mavenprofserv.com/clinical-evaluation-plan/
business@mavenprofserv.com
enquiry@mavenprofserv.com