Clinical Evaluation Report.pdf
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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/
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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/
Clinical Evaluation Report.pptx
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/
clinical-evaluation-report (CER)
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 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.
Post-Market Clinical Follow Up Studies Under EU MDR and IVDR
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...
Clinical Evaluation Report for Medical Devices
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 Evaluation in the EU for Medical Devices: Understanding the Changes ...
A new revision of MEDDEV 2.7.1 is now available and this revision represents a complete rewrite, with massive changes.
The new MEDDEV is both more instructive, and more prescriptive in particular regarding the use of evidence from equivalent devices.
So what exactly are the implications of all these changes for device manufactures?
How does this affect your CERs?
How long is the transition period going to be? (Hint: there’s typically no transition provided for the MEDDEVs).
Join us for this free, 60 minute webinar, presented by our guest Keith Morel, VP of Regulatory Compliance at Qserve Group US Inc., on July 21st.
(You can view the full webinar at: http://www.greenlight.guru/webinar/clinical-evaluation-eu-meddev-2_7_1-rev-4)
Specifically, you will learn:
What is MEDDEV 2.7.1. Rev 4 for Clinical Evaluation in EU and why exact does this matter to device makers?
What are some of the most significant changes? (There are a lot of them)
How does it align with the changes to the new EU MDR?
In what ways will demonstrating “equivalence” now be harder?
How often you must update your CERs now and what qualifications the evaluators must have?
How should you prepare for the increased notified body scrutiny?
How do you perform a clinical literature review to meet the new expectations?
Do you need to write a CER for CE Marking? If not, when else do you need to do this and with what focus?
The secret formula to getting health tech to market
The UK Israel Tech Hub has partnered with some of the UK’s leading healthcare consultancies to bring you this carefully curated series to help demystify the UK and its wonderful National Health Service, focusing on getting back to business and not on COVID-19.
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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/
Clinical Evaluation Report.pptx
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/
clinical-evaluation-report (CER)
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 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.
Post-Market Clinical Follow Up Studies Under EU MDR and IVDR
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...
Clinical Evaluation Report for Medical Devices
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 Evaluation in the EU for Medical Devices: Understanding the Changes ...
A new revision of MEDDEV 2.7.1 is now available and this revision represents a complete rewrite, with massive changes.
The new MEDDEV is both more instructive, and more prescriptive in particular regarding the use of evidence from equivalent devices.
So what exactly are the implications of all these changes for device manufactures?
How does this affect your CERs?
How long is the transition period going to be? (Hint: there’s typically no transition provided for the MEDDEVs).
Join us for this free, 60 minute webinar, presented by our guest Keith Morel, VP of Regulatory Compliance at Qserve Group US Inc., on July 21st.
(You can view the full webinar at: http://www.greenlight.guru/webinar/clinical-evaluation-eu-meddev-2_7_1-rev-4)
Specifically, you will learn:
What is MEDDEV 2.7.1. Rev 4 for Clinical Evaluation in EU and why exact does this matter to device makers?
What are some of the most significant changes? (There are a lot of them)
How does it align with the changes to the new EU MDR?
In what ways will demonstrating “equivalence” now be harder?
How often you must update your CERs now and what qualifications the evaluators must have?
How should you prepare for the increased notified body scrutiny?
How do you perform a clinical literature review to meet the new expectations?
Do you need to write a CER for CE Marking? If not, when else do you need to do this and with what focus?
The secret formula to getting health tech to market
The UK Israel Tech Hub has partnered with some of the UK’s leading healthcare consultancies to bring you this carefully curated series to help demystify the UK and its wonderful National Health Service, focusing on getting back to business and not on COVID-19.
Malaysia Medical Devices Regulations
The Medical Device Regulations 2012, the subsidiary legislations under the Medical Device Act 2012 (Act 737), has been approved by the Malaysian Minister of Health and has been published in the Gazette on 31st December 2012. The Regulations will come into operation simultaneously with Act 737 on 1st July 2013. And as specified in Act 737 a transition period of two years for medical device registration and one year for establishment licensing will be given to the industry before it is fully enforced.
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The document provides an overview of the New Drug Application (NDA) process. It discusses that an NDA is required for approval to market a new drug in the US. The goals of an NDA are to demonstrate a drug's safety, efficacy, appropriate labeling, and quality manufacturing. An NDA contains extensive data from non-clinical and clinical trials. It follows a common technical document format and is reviewed by the FDA to determine if the drug's benefits outweigh the risks for approval.
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This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
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Introduction
Definition
Classification
Regulatory registration procedure
Quality system requirements
Clinical evaluation
Investigation of medical devices
Summary
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration (CFDA)
Manufacturers must register their devices with the NMPA before selling or distributing in China.
The NMPA reviews all device applications and has strict requirements for submission documentation, testing, and clinical data.
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application.
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of compensation for an injury or handicap conditions
Investigation, replacement or modification for anatomy or a physiological process
Control of conception
The Chinese authorities (CFDA/NMPA) have their own quality management system requirements.
However, these “GMP requirements” are very similar to ISO 13485.
Therefore, manufacturers usually submit the ISO 13485 certificate.
However, the audit will review this certificate against the Chinese GMP requirements.
These audits are regularly carried out during the approval procedure and/or after a recall.
NMPA issued and implemented the "Guideline on Inspection of Quality Management System for Medical Device Registration" on October 10, 2022.
Product Life-cycle Process
The guideline specifies the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. Applicant needs to:
Ensure the design, development, production, and other process data to be true, accurate, complete, and traceable, and consistent with the registration application materials.
Carry out the registration QMS inspection in reference to the registration application materials, and focus on the design, development, procurement, production management, and quality control of the product.
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The evaluation involves reviewing existing clinical data, scientific literature, and relevant clinical research to assess the safety and performance of the device.
All clinical trials for medical devices must follow China Good Clinical Practices
Clinical investigations are required if no equivalent devices can be found and safety and efficacy cannot be proven with other clinical and non-clinical data.
For certain medical devices, the NMPA may require clinical investigations, especially for novel devices or those with significant risk.
Clinical investigations involve conducting studies on human subjects to generate clinical data on the safety and effectiveness of the device.
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Introduction
Definition
Classification
Regulatory registration procedure
Quality system requirements
Clinical evaluation
Investigation of medical devices
Summary
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration (CFDA)
Manufacturers must register their devices with the NMPA before selling or distributing in China.
The NMPA reviews all device applications and has strict requirements for submission documentation, testing, and clinical data.
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application.
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of compensation for an injury or handicap conditions
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The Chinese authorities (CFDA/NMPA) have their own quality management system requirements.
However, these “GMP requirements” are very similar to ISO 13485.
Therefore, manufacturers usually submit the ISO 13485 certificate.
However, the audit will review this certificate against the Chinese GMP requirements.
These audits are regularly carried out during the approval procedure and/or after a recall.
NMPA issued and implemented the "Guideline on Inspection of Quality Management System for Medical Device Registration" on October 10, 2022.
Product Life-cycle Process
The guideline specifies the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. Applicant needs to:
Ensure the design, development, production, and other process data to be true, accurate, complete, and traceable, and consistent with the registration application materials.
Carry out the registration QMS inspection in reference to the registration application materials, and focus on the design, development, procurement, production management, and quality control of the product.
For lower-risk medical devices (Class I and Class II), clinical evaluation may not always be required. However, higher-risk devices (Class III and implantable devices) generally require clinical evaluation.
The evaluation involves reviewing existing clinical data, scientific literature, and relevant clinical research to assess the safety and performance of the device.
All clinical trials for medical devices must follow China Good Clinical Practices
Clinical investigations are required if no equivalent devices can be found and safety and efficacy cannot be proven with other clinical and non-clinical data.
For certain medical devices, the NMPA may require clinical investigations, especially for novel devices or those with significant risk.
Clinical investigations involve conducting studies on human subjects to generate clinical data on the safety and effectiveness of the device.
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Clinical Evaluation Report.pdf
- 2. CONTENT Clinical Evaluation Report MEDDEV 2.7/1 Rev 4 Guideline FAQ
- 3. CLINICAL EVALUATION REPORT 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.
- 4. If manufacturers want to place your devices in European Market, they must prepare and maintain a clinical evaluation report that complies with the requirements of MEDDEV 2.7.1. rev. 4 and EU MDR Article 61 and Annex XIV part A. Maven Profcon Services LLP. has a team of experienced professionals who are well versed with the CE regulations and literature reviews to compile your CER.
- 5. In accordance with the European regulation, the clinical evaluation and the clinical evaluation report must be actively updated with data obtained from post-market surveillance. All clinical data sets shall be documented, adequately summarised, appraised, analysed and referenced) in the clinical evaluation report. The appraisal should be documented in the clinical evaluation report to the extent that it can be critically reviewed by others.
- 6. Clinical evaluation report shall also include current state of art and clinical background of the device and the evaluators should check the clinical evaluation report, provide verification that it includes an accurate statement of their analysis and opinions, and sign the clinical evaluation report.
- 7. MARKETING STRATEGY MEDDEV 2.7/1 Rev 4 Guideline The MEDDEV 2.7/1 Rev 4 guidelines, released in June 2016, provide updated guidance on clinical evaluation for the medical device manufacturers and noticed 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.
- 8. FAQ What is clinical evaluation? Clinical evaluation a methodologically sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant general safety and performance requirements for safety and performance when using the device according to the manufacturer’s Instructions for Use. 1.
- 9. Evaluators should possess a knowledge and experience in research methodology and systemic search strategy using certain databases. 2. Who can perform the clinical evaluation? It has been mentioned clearly in section 6.4 of MEDDEV guideline for clinical evaluation that manufacturer should consider certain aspects in selecting the evaluators and justifying the same. Certain aspects need to be considered while selecting a evaluator are:
- 10. Prior knowledge in regulatory requirements and in medical writing where experts in systemic reviewing of the literature and clinical data appraisal Knowledge of device technology and its application A degree from respective field and 5 years documented professional experience or 10 years of documented professional experience if degree is not a pre-requisite.
- 11. 3. What is difference between clinical evaluation and clinical investigation? Clinical investigation is systematic investigation in one or more human subjects, to assess the safety or performance of a medical device and Clinical evaluation of medical devices is a systematic and planned process that contributes to the continuous generation, collection, analysis and evaluation of clinical data on a particular device.