#PMCF Plan

[iziel-healthcare]

What is Post-Market Clinical Follow-Up?

PMCF study is carried out for CE certified medical devices that are placed in the market. It’s a method of proactive collection of clinical data to analyze the emergent risks/side-effects of the medical device to demonstrate the safety and performance as per the intended purpose, throughout the expected lifetime of the device.

Performance and safety parameters are predefined with acceptance criteria based on the benchmark devices data, and milestones are designed for several PMCF studies and activities. The literature screening and registries study also supports PMCF findings. The sample size is predefined as per the sales of the device to study the emergent risks. Benefit-risk ratio analysis is performed as per the PMCF findings, for the acceptability of the device in the market. The PMCF findings are also documented in Technical Documentation, Risk File, SSCP, CER and PSUR

PMCF Includes

PMCF Procedure

PMCF Plan

PMCF Report

PMCF Plan

PMCF Protocol

Sample Size

Design of Milestones with follow-up period

Design of measurable endpoints for performance and safety

Ethical Committee approval

Questionnaire/Survey form

Patient/subjects consent form

Clinical Investigation/Trial procedure (if any)

Real World Evidence

Statistical Significance 

PMCF Report

Milestones completion

Real World Evidence analysis

Literature Screening

Registries

Questionnaires and Surveys results

Feedback from users/end user

Clinical Investigations/Trials results (if planned any)

Outcome of performance and safety endpoints

Risk benefit analysis

Residual Risks (if any)

Statistical Analysis

CER citation

Frequency of PMCF update

IZiel Healthcare offers PMS services to our clients where we perform end to end Post Market Surveillance activities. These services can be PMS Plan, PMS/PSUR Reports, PMCF Plan and Reports, Trend Reporting, Complaint Handling, Clinical Evaluation, Risk Benefit Management and many more.

We have expertise in designing PMCF Plan and drafting reports for our clients for all the Classes of Medical devices – Class IIa, Class IIb and Class III.

You may contact us at Contact Us – Iziel.

[sudheervanguri]

Wipro is currently seeking skilled professionals with 4-6 years of experience in medical writing for their growing team. This opportunity is perfect for those with expertise in Clinical Evaluation Reports (CER), Periodic Safety Update Reports (PSUR), and Post Market Clinical Follow-Up (PMCF). With a flexible hybrid work model available, this position is open to candidates across Pan India. Job Overview: Company: Wipro Ltd. Position: Medical Writers | CER, PSUR, PMCF | Medical Devices Work Location: Pan India (Hybrid) Experience Required: 4-6 years Qualification: Life Science Graduate Job Type: Full-time, Mid-Senior Level Key Responsibilities: CER Writing and Drafting: PSUR Development and Updates PMCF Planning and Reporting Cross-functional Collaboration Qualifications and Requirements: Educational Background: A Life Science Graduate is required. Preferred degrees include B.Sc., M.Sc., B. Pharma, M. Pharma or other relevant qualifications related to the medical field. Professional Experience: 4-6 years of experience in medical writing, particularly in the medical devices industry. Experience working on Clinical Evaluation Reports (CER), PSUR, and PMCF is a must. Technical Skills: Proficiency in medical writing tools and understanding of ISO 13485, MDR, and regulatory guidelines. Strong research and analytical skills to interpret clinical data and present findings clearly. Soft Skills: Excellent written and verbal communication skills. Ability to work collaboratively in a cross-functional team environment. How to Apply: Interested candidates are applying through LinkedIn

[swapnamakro]

What is the importance of Post-Market Clinical Follow-Up (PMCF) for medical devices?

Post-Market Clinical Follow-Up (PMCF) is vital for medical devices as it ensures continuous safety and effectiveness throughout the device's lifecycle. Regulatory bodies, like the European Medical Device Regulation (MDR), have stringent requirements that demand manufacturers to provide ongoing clinical evidence post-market. This process not only safeguards patient health but also builds trust with healthcare providers and patients.

A well-executed PMCF plan can identify potential risks and areas for improvement that may not have been evident during pre-market trials. It’s a proactive approach that helps manufacturers stay ahead of regulatory changes and avoid costly product recalls or modifications.

For companies looking to streamline their PMCF activities, adopting a strategic and compliant approach is essential. If you’re looking for expert guidance on how to develop a high-level approach for your PMCF activities, consider reading this comprehensive blog High-Level Approach for PMCF Activities. It provides actionable insights and strategies that can help you navigate the complexities of PMCF with confidence.

[research-on-future]

Innovations in Medical Device Vigilance: Trends, Challenges, and Solutions

Here are 20 Points about the European Medical Device & Diagnostics Post-Market Surveillance and Vigilance Conference:

Purpose: The conference aims to provide a platform for stakeholders in the medical device and diagnostics industry to discuss post-market surveillance (PMS) and vigilance strategies.

Industry Focus: It focuses on the European market and the regulatory landscape governing medical devices and diagnostics.

Regulatory Compliance: Sessions cover the latest updates and requirements related to post-market surveillance and vigilance regulations, including the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Expert Speakers: The conference features expert speakers from regulatory agencies, industry associations, notified bodies, and medical device companies who share insights, best practices, and case studies.

Key Topics: Topics include PMS planning and implementation, adverse event reporting, trend analysis, risk management, post-market clinical follow-up (PMCF), and communication with competent authorities.

CONFERENCE REGISTRATION Available @ https://shorturl.at/otvGQ

Networking Opportunities: Attendees have the opportunity to network with peers, regulators, and industry experts, fostering collaboration and knowledge sharing.

Case Studies: Real-life case studies highlight challenges and solutions in post-market surveillance and vigilance, providing practical insights for attendees.

Interactive Workshops: Workshops offer hands-on learning experiences, allowing participants to dive deeper into specific topics and exchange ideas with fellow attendees.

Technology Showcase: A technology showcase allows vendors to demonstrate innovative solutions and tools for enhancing post-market surveillance and vigilance activities.

Global Perspectives: While focused on Europe, the conference may also feature speakers and discussions that provide insights into post-market surveillance practices in other regions, such as the United States and Asia.

Continuing Education: Attendees may earn continuing education credits or certificates of attendance, depending on the conference's accreditation status.

Compliance Strategies: Sessions explore practical strategies for ensuring compliance with post-market surveillance and vigilance requirements, helping companies mitigate risks and maintain regulatory compliance.

Data Analytics: Discussions may delve into the role of data analytics and artificial intelligence in enhancing post-market surveillance processes, including signal detection and risk assessment.

Patient Safety: The conference emphasizes the importance of post-market surveillance and vigilance in ensuring patient safety and product quality.

Become a Sponsor @ https://shorturl.at/egvQ7

Quality Management Systems: Sessions may cover the integration of post-market surveillance activities into a company's quality management system (QMS), ensuring a systematic approach to compliance.

Continuous Improvement: Attendees learn how to establish processes for continuous improvement in post-market surveillance and vigilance, adapting to regulatory changes and emerging risks.

Compliance Challenges: Panels and discussions address common challenges faced by medical device and diagnostics companies in meeting post-market surveillance and vigilance requirements, offering strategies for overcoming obstacles.

Legal and Ethical Considerations: Legal and ethical considerations related to post-market surveillance, including data privacy and informed consent, may be explored during the conference.

Industry Trends: The conference provides insights into emerging trends and developments shaping the future of post-market surveillance and vigilance in the medical device and diagnostics industry.

Actionable Insights: Attendees leave the conference with actionable insights, practical strategies, and valuable connections to support their organizations' post-market surveillance and vigilance efforts.

Become a Speaker @ https://shorturl.at/EgNqi

[omcmedicalblog]

Staying Vigilant: Best Practices for Post-Market Surveillance under EU MDR

As medical device manufacturers navigate the landscape of post-market surveillance (PMS) under the European Medical Device Regulation (EU MDR), maintaining vigilance and adherence to best practices is crucial. Effective PMS not only ensures ongoing product safety and efficacy but also facilitates compliance with regulatory requirements.

Top 7 Key Strategies for optimizing Post-Market Surveillance

Here, we outline key strategies for optimizing post-market surveillance in alignment with EU MDR standards.

Early Integration of Post-Market Surveillance into Quality Management

Integrate post-market surveillance activities into your quality management system (QMS) from the outset of product development. By incorporating PMS processes early, you establish a solid foundation for ongoing monitoring and compliance with EU MDR requirements.

This proactive approach mitigates risks and facilitates timely identification and resolution of issues in the post-market phase.

Implement Robust Post-Market Monitoring Protocols

Establish comprehensive post-market monitoring protocols to systematically collect, analyze, and respond to data related to device performance, adverse events, and customer feedback.

Regularly review and update these protocols to align with evolving regulatory guidelines and industry best practices. By conducting thorough post-market monitoring, you demonstrate a commitment to patient safety and regulatory compliance.

Leverage Purpose-Built Tools for PMS

Utilize specialized software solutions designed for medical device surveillance and post-market monitoring. These tools offer features such as complaint handling, nonconformance management, and CAPA processes tailored to EU MDR requirements.

By leveraging purpose-built tools, you streamline PMS workflows, enhance data accuracy, and ensure compliance with regulatory standards.

Foster Cross-Functional Collaboration

Promote cross-functional collaboration and communication across departments involved in post-market surveillance, including regulatory affairs, quality assurance, and product development.

Establish clear channels for reporting and escalating issues, facilitating timely decision-making and corrective actions. By fostering a collaborative culture, you enhance transparency and accountability in PMS activities.

Ensure Compliance with Post-Market Requirements

Stay informed and up-to-date on the latest post-market requirements outlined in EU MDR legislation. Regularly review guidance documents and regulatory updates issued by competent authorities to ensure compliance with reporting obligations, vigilance requirements, and post-market clinical follow-up (PMCF) obligations.

By maintaining compliance with post-market requirements, you mitigate regulatory risks and uphold patient safety standards.

Enhance Data Traceability and Documentation

Maintain comprehensive traceability of post-market surveillance activities through robust documentation and data management practices. Implement systems for documenting complaints, adverse events, corrective actions, and other PMS-related information in accordance with EU MDR documentation requirements.

By enhancing data traceability, you facilitate regulatory inspections and demonstrate compliance with post-market obligations.

Embrace Continuous Improvement

Embrace a culture of continuous improvement in post-market surveillance processes, leveraging data-driven insights to drive enhancements and optimizations.

Regularly assess the effectiveness of PMS activities, identify areas for improvement, and implement corrective measures as needed. By prioritizing continuous improvement, you demonstrate a commitment to excellence in post-market surveillance and patient safety.

In conclusion, staying vigilant in post-market surveillance under EU MDR requires proactive planning, robust monitoring protocols, and a commitment to compliance with regulatory requirements.

By integrating PMS into quality management systems, leveraging purpose-built tools, fostering cross-functional collaboration, and embracing continuous improvement, medical device manufacturers can navigate the complexities of post-market surveillance with confidence and ensure ongoing regulatory compliance.

Originally Published at: https://omcmedical.com/key-strategies-optimizing-post-market-surveillance/

[izielhealthcare]

Navigating the Maze: Understanding Clinical Evaluation Reports for Medical Devices

In the realm of medical devices, ensuring their safety and effectiveness is paramount to safeguarding patient health. Clinical Evaluation Reports (CERs) play a pivotal role in this process, providing a comprehensive assessment of a medical device's clinical performance. This blog aims to demystify the world of Clinical Evaluation Reports, shedding light on their significance, components, and the intricate process involved in their creation.

What is a Clinical Evaluation Report (CER)?

A Clinical Evaluation Report is a systematic and critical analysis of clinical data pertaining to a medical device. It is a crucial component of the regulatory submission process, providing evidence that supports the device's safety and performance throughout its lifecycle. The goal is to ensure that the benefits of the medical device outweigh any potential risks.

Key Components of a CER:

1. Device Description:

   - Begin with a detailed description of the medical device, including its intended use, design, and specifications.

   - Highlight any modifications or changes made to the device since the previous evaluation.

2. Literature Review:

   - Conduct a thorough review of existing scientific literature related to the device's class and intended use.

   - Summarize relevant studies, publications, and clinical trials, emphasizing their methodology and findings.

3. Clinical Data:

   - Present clinical data generated from the device itself or similar devices.

   - Include information on patient populations, study design, endpoints, and statistical analyses.

   - Evaluate the data to demonstrate the device's safety, performance, and clinical benefits.

4. Risk Analysis:

   - Identify and assess potential risks associated with the medical device.

   - Evaluate the severity and likelihood of each risk, taking into account mitigation measures.

   - Ensure alignment with ISO 14971 standards for risk management.

5. Clinical Justification:

   - Provide a robust justification for the clinical evidence presented.

   - Address any gaps or limitations in the data and explain how they are mitigated.

   - Clearly articulate how the clinical data supports the device's safety and efficacy.

6. Post-Market Clinical Follow-up (PMCF):

   - Outline plans for post-market surveillance and ongoing clinical follow-up.

   - Describe methodologies for collecting real-world data to monitor the device's performance over time.

7. Conclusion and Recommendations:

   - Summarize the key findings of the CER.

   - Provide recommendations for the device's use, potential modifications, or additional studies if needed.

Challenges in Creating CERs:

1. Data Quality and Availability:

   - Obtaining high-quality clinical data can be challenging, especially for novel or unique devices.

   - The reliance on published literature may not always align perfectly with the specific device in question.

2. Regulatory Compliance:

   - Keeping up-to-date with evolving regulatory requirements is crucial.

   - Ensuring compliance with standards such as MEDDEV 2.7.1/Rev. 4 in Europe or the FDA's guidance documents in the United States is a continuous process.

3. Interpretation of Clinical Data:

   - Analyzing and interpreting clinical data require expertise and may involve subjective judgment.

   - The challenge lies in presenting a comprehensive and objective analysis that stands up to regulatory scrutiny.

In the intricate landscape of medical device regulation, Clinical Evaluation Reports serve as the cornerstone for establishing the safety and efficacy of devices. Crafting a thorough and well-documented CER is a collaborative effort that involves expertise in clinical research, regulatory affairs, and risk management. By navigating the complexities of CER creation, manufacturers contribute to the overall enhancement of patient safety and confidence in the medical devices they bring to market.

[regulatoryworld]

Clinical Evaluation vs Clinical Performance

What Does Clinical Evaluation Mean?

Three fundamental goals are the focus of clinical evaluation:

· Demonstrate acceptable clinical safety for a device.

· To prove the device's performance, use clinical performance.

· Prove that there is a positive clinical advantage over risk.

According to Article 2 (44) of the EU MDR, "means a systematic, planned process to continuously create, collect, analyze, and assess the clinical data pertaining a device, in verifying the safety and performance of the device, including the clinical benefits when it is used as intended by its manufacturer."

Let's take a look at it:

"Systematic, planned" - You must document the procedures you use to conduct a clinical assessment and provide documentation of your planning.

"Continuously create, collect, analyze, and assess the clinical information"- This keyword ‘Clinical evaluation’ does not end with the initial device being developed. It continues throughout its lifecycle. Therefore, you are constantly analyzing and generating data. Your Notified Body will request this.

Verify safety and performance, including the clinical benefits. This refers to the benefit-risk ratio or benefit versus risk analysis. It is how you meet the MDR.'s General Safety and Performance Requirements of the MDR. That has more information about measuring benefits.

Clinical evaluation of medical device refers to the collection, analysis, appraisal, and summary of clinical data from various sources, including clinical literature, nonperformance data, and equivalent devices and post-market data.

 What Does Clinical Performance Mean?

Clinical performance refers to the outcome of clinical evaluation based on the analysis and summation of all clinical data. It results from Stage 3 clinical evaluation that supports how a device performs according to its intended performance.

The term performance is often misunderstood. This refers to the device's clinical performance, not its functional attributes or specifications. In addition, the definition of performance can vary widely depending on the product. Therefore, you must differentiate these terms in your technical documentation when conducting your clinical evaluation. This will ensure that your Notified Body does not experience confusion. You must also be precise in linking specific data to each definition.

Data can be derived from many sources, including:

·  Clinical literature for devices

·  Clinical trials

·  Factors that improve the usability

·  Equivalent devices

·  Post-market clinical follow-up (PMCF).

·  State-of-the-art

 ACCORDING TO THE MANUFACTURER, the MDR Article 2 (52) defines clinical performance as "... the ability of a device to achieve its intended purpose.

It means your device must perform according to the specifications when it is used in a way that benefits patients. This should not be confused for clinical safety.

Do you need immediate assistance? Need immediate assistance? Our CER consultant team can help with literature reviews, strategy, and compilation.

 Related - What do you mean by Clinical Writing?

[meeraoperon]

Medical Device Technical Documentation for MDR

Medical Device Technical Documentation for MDR means a set of documents demonstrating a specific product’s compliance with the relevant CE marking legislation. The documentation must indicate the applicable product safety standards and requirements and cover the product’s design, manufacture, and operation.

Medical Device Technical Documentation for MDRThe technical Documentation or dossier includes detailed information about the design, function, , use, claims, material of construction and clinical evaluation of your medical device.They are required for all classes of devices (Class I, I Measuring, I Sterile, IIa, IIb, and III), but no two files are the same because the type of device dictates the information included therein. Unless you manufacture a Class I device that is not provided sterile and does not have a measuring function, your Technical File must be reviewed by a Notified Body. Understanding how to assemble this information and present it for review by Notified Bodies is essential.MDR Technical DocumentationQA and Regulatory team members are always confused or find it difficult in identifying the required number of medical device technical files for the products planned for European CE Marking.It is advised to remember that medical device technical file or documentation is all about your device to establish safety and performance. It means you cannot combine products with the different intended use, or different class, or different construction material, or even different design.Medical Device Technical FileRequirement & Identification as per CE MDR Risk classification and identification of assessment route of CE Marking General Safety and performance requirement evaluation. Systmatically organize and arrange Files and review. Clinical Evaluation documentation covering PMS, PMCF & PSUR Risk Analysis Medical Device Quality Management System Implementation Read More -  Medical Device Technical Documentation for MDR Visit Us - CE Marking  Read More Article - 1. Orthopedic Implants Manufacturing 2. disposable syringe manufacturers 3. Dental Implants Manufacturing 4.Blood Collection Tubes Manufacturing Contact details – Phone no -  9325283428 Mail  - dm@operonstrategist.com

[i3cglobalblog]

POST-MARKET CLINICAL FOLLOW-UP (PMCF)

Post-marketing clinical follow-up, PMCF is the systematic process of updating the clinical evaluation. It consists of a continuous process of updating the clinical evaluation of the product, by the manufacturer, once it is placed on the market; with its CE marking and during the entire useful life of the product. post market clinical follow up .

 It is intended to answer specific questions related to the clinical safety or performance of a device when used as directed by the manufacturer, to ensure acceptability of known risks, and to detect new risks.

 ORIGIN OF THE INFORMATION

The way to obtain this information will be carried out by:

Compilation of articles from scientific publications

Carrying out market research of the product

Through surveys conducted with health professionals who can provide clinical experience related to the product             

Surveys carried out on patients or users of the product in question

Compilation of reports demonstrating misuse or unauthorized use of the product

Conducting clinical research

Evaluation of clinical data obtained from equivalent or similar products

Claims from users, distributors or importers

 The manufacturer will analyze the findings obtained and, with the results, will generate an evaluation report that will form part of the clinical evaluation and technical documentation of the product and if it is observed that there is a need to take preventive and / or corrective measures, the manufacturer must to apply them post market surveillance .

 POST-MARKETING CLINICAL FOLLOW-UP PLAN

The PMCF will be carried out following a documented method established in the post-marketing clinical follow-up plan where we will speak in future publications.

[i3c-global]

Understanding Clinical Evaluation and its purpose

Clinical Evaluation means the assessment and the analysis of clinical data pertaining to a medical device to verify its clinical safety and performance, including the benefits, of the device when used as intended by the manufacturers.

It is a continuous process where it is initially conducted during the conformity assessment process leading to the marketing of the Device.

Clinical evaluation is mandatory for CE marking.

The process is then repeated periodically throughout the life of the device as new clinical safety and performance information such as post market surveillance reports or adverse reports and obtained during its use.

Pre-market research and development are guided by clinical evaluation. Manufacturers carry out Clinical evaluation to:

Define need regarding clinical safety and performance of the device.

If the device is already in the market, then evaluate the clinical data.

Conduct the gap analysis, and define which data is needed to generate with the device under the evaluation.                                                               - If a gap present that cannot be addressed by other means, clinical evaluation should be planned to define the study design.

Post-market manufacturer monitors the market and systematically collects clinical data on its product (PMS, PMCF)

The manufacturer must formulate a new plan, which includes to

confirm the safety and the performance of the devices

identify and monitor the side effect

identify and investigate risk

monitor the benefit/risk ratio

What is considered Clinical data as per MDR?

Clinical data is information about the safety and performance of the device, which may be derived from the clinical trials of the Device, other studies reproduced in scientific literature relating to a product which can be shown to be similar to the product concerned, scientific literature on the other clinical experiences either with the product concerned or with a product whose identity with the product concerned can be demonstrated, clinically relevant information from PMCF (Post market clinical follow-up study)

Is it mandatory to conduct the clinical evaluation for all classes of the medical devices as per MDR?

Yes, for all classes the clinical evaluation is mandatory. Device classes for obtaining CE marking

Class I — low-risk device

Class IIa — medium-risk device

Class IIb- medium to high risk

Class III- high risk

Purpose of Clinical Evaluation Plan

The aim of clinical evaluation plan is to define the scope and record the clinical evaluation approach. Also, to develop the scope of the clinical evaluation to be conducted on the medical device. Clinical evaluation plan (CEP) includes the method, scope, and procedure to reach conclusion in clinical evaluation to record it in Clinical evaluation report.

Clinical Evaluation Plan should include all the information regarding the device under evaluation. Including the Specification of device, the intended use of device, description of device, Target population. Detailed information of clinical benefits and outcome parameters. Detailed description of the Characteristics of the device. If any the claims by manufacturers on safety and the performance of the device that should be mention in CEP.

Thanks for Reading. If you want to know more about Clinical Evaluation Process. Kindly visit our website www.i3cglobal.com

[sudheervanguri]

Regulatory affairs associate, Clinical writing, Clinical affairs Job openings for BSc, B Pharmacy, M Pharam, BDS & MBBS Candidates 2022

Regulatory affairs associate, Clinical writing, Clinical affairs Job openings for BSc, B Pharmacy, M Pharam, BDS & MBBS Candidates 2022

HealthMinds Hiring Notification for Clinical writing, Regulatory affairs associate, Clinical affairs Departments Vacancies information Described Below. Healthmind releases Notification today for above departments. Interested, Eligible Candidates Apply through below information. Clinical Writing Services CEP/CER/PMCF Plans/ PMCF Reports Qualifications: BSc / B Pharam / M Pharam / BDS /…

[swapnamakro]

Post Market Clinical Follow Up (PMCF) Consulting

Post Market Clinical Follow Up (PMCF) consulting is essential for medical device manufacturers to ensure ongoing compliance and safety. PMCF activities involve the continuous monitoring and evaluation of a device's performance and safety once it is on the market. Our expert consulting services help you design and implement effective PMCF plans, collect and analyze real-world data, and address regulatory requirements. Stay ahead in the evolving regulatory landscape with tailored PMCF strategies that support device improvements and safeguard patient well-being.

For more info: https://www.makrocare.com/devices/clinical/pmcf/

[omcmedicalblog]

Strategic Approach to Compliance: Mastering the Quality Management System (QMS) in EU MDR

QMS (Quality Management System) and ISO 13485

A Quality Management System is defined by ISO 13485 as a set of processes, procedures, and responsibilities for achieving quality policies and objectives in a medical device manufacturing organisation. It is a structured system that ensures that medical devices consistently meet customer and regulatory requirements.

ISO 13485 is an international standard that specifies requirements for a QMS specific to the medical device industry. ISO 13485 is a stand-alone QMS standard based on ISO 9001:2008, superseded by ISO 9001:2015.

It covers the design, development, production, storage, distribution, installation, servicing, and final decommissioning of medical devices.

Implementing a QMS based on ISO 13485 helps organisations demonstrate their ability to provide medical devices and related services that meet customer expectations and regulatory requirements, fostering customer confidence and regulatory compliance.

One of the critical advantages of ISO 13485 is that it ensures a strong starting point if a manufacturer wants to certify their products under the EU Medical Device Regulation and In Vitro Diagnostic Regulation (IVDR).

MDR requirements for QMS

EU MDR states the requirement for a well-established and maintained QMS in Article 10 (9).

Article 10 of the Medical Device Regulation (MDR) outlines a set of criteria governing Quality Management Systems (QMS) for Manufacturers operating in the medical device sector.

This article mandates that manufacturers establish, document, implement, maintain, update, and enhance a QMS that aligns with MDR specifications. Furthermore, it stipulates that the QMS must be aligned with the risk classification, the nature of the device and the business.

Article 10 specifies several fundamental aspects that the QMS must address at a minimum, which are as follows:

A strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system.

Identification of applicable general safety and performance requirements and exploration of options to address those requirements.

Responsibility of the management.

Resource management, including selection and control of suppliers and sub-contractors.

Risk management is set out in Section 3 of Annex I.

clinical evaluation by Article 61 and Annex XIV, including PMCF.

Product realisation, including planning, design, development, production, and service provision.

Verify the UDI assignments made by Article 27(3) to all relevant devices and ensure the consistency and validity of the information provided by Article 29.

Setting up, implementing and maintaining a post-market surveillance system in accordance with Article 83.

Handling communication with competent authorities, notified bodies, other economic operators, customers and other stakeholders.

Processes for reporting serious incidents and field safety corrective actions in the context of vigilance.

Management of corrective and preventive actions and verification of their effectiveness.

Processes for monitoring and measurement of output, data analysis and product improvement.

This list of minimum requirements highlights that the Quality Management System necessitates a documented procedure for all significant activities directly associated with individual medical devices, along with broader processes about the company’s overall operations.

The EU MDR does not impose specific requirements for a QMS. However, manufacturers are responsible for implementing appropriate content tailored to the risk class and organisational nature.

How do you implement a QMS that actually works?

Manufacturers can utilise harmonised standards, such as ISO, to aid in implementing MDR requirements. Compliance with recognised harmonised standards, like ISO 13485:2016 for Quality Management Systems, establishes a presumption of conformity with relevant aspects of the MDR.

ISO 13485 provides detailed provisions for developing QMSs that align with most MDR quality management requirements.

Manufacturers must, therefore, ensure that a system compliant with both ISO standards and the MDR requirements outlined in Article 10 is in place to address the comprehensive demands of quality management in the medical device industry.

A manufacturer’s quality management system will be assessed as part of the conformity assessment procedures outlined in MDR Annex IX to XI. Conformity assessment for Class Ir, Is, a Notified Body will carry out Im, IIa, IIb and III devices.

Formal evaluation and certification by a notified body are not conducted for Class I devices, but the QMS requirements still apply.

Originally Published at: https://omcmedical.com/mastering-qms-in-eu-mdr/

[izielhealthcare]

Clinical Evaluation Report for Medical Devices

A Clinical Evaluation Report (CER) for medical devices is a comprehensive document that assesses the safety and performance of a medical device through the review and analysis of clinical data. The purpose of a CER is to demonstrate the device's conformity with relevant regulations, standards, and requirements, such as the Medical Device Regulation (MDR). A well-prepared CER plays a crucial role in gaining regulatory approval and ensuring the device's ongoing compliance throughout its lifecycle.

Here's an outline of the key components typically included in a Clinical Evaluation Report:

1. Device Description and Intended Use:

   - Provide a detailed description of the medical device, including its specifications, intended use, and indications for use.

   - Clearly define the device's intended purpose, patient population, and the medical condition it is intended to address

2. Clinical Literature Review:

   - Conduct a systematic and thorough review of relevant scientific literature, clinical studies, and post-market surveillance data related to the device and similar devices.

   - Evaluate the quality and relevance of the literature sources and identify any potential gaps or inconsistencies.

3. Clinical Data Sources:

   - Identify and include all clinical data sources, such as clinical investigations, clinical trials, post-market surveillance, and any other relevant clinical studies.

   - Consider both primary data generated by the manufacturer and external data from the literature.

4. Risk Assessment and Benefit-Risk Analysis:

   - Assess potential risks associated with the device's use and its components.

   - Perform a comprehensive benefit-risk analysis to demonstrate that the benefits of the device outweigh its potential risks for the intended patient population.

5. Clinical Evaluation Plan:

   - Outline the strategy and methodology used to collect, analyse, and evaluate clinical data.

   - Specify the criteria for selecting relevant clinical studies, data endpoints, and statistical methods used for analysis.

6. Clinical Data Analysis:

   - Present a summary of the clinical data collected, including study design, patient demographics, outcomes, adverse events, and any relevant trends.

   - Analyse and interpret the data to assess the device's safety and performance.

7. Clinical Performance:

   - Evaluate the device's clinical performance against the intended purpose and performance claims.

   - Highlight any deviations, variations, or limitations observed during clinical studies.

8. Conclusions and Clinical Evaluation Summary:

   - Summarize the findings of the clinical evaluation, drawing conclusions about the device's safety and performance.

   - Address any uncertainties or gaps in the data and discuss how they are managed.

9. Post-Market Clinical Follow-Up (PMCF):

   - Describe the manufacturer's plan for ongoing data collection after the device is placed on the market.

   - Outline the PMCF activities and how they contribute to the continued assessment of the device's performance and safety.

A well-prepared Clinical Evaluation Report should demonstrate a thorough understanding of the device's clinical data, its benefits, and its safety profile. It should also show compliance with relevant regulatory requirements and standards. It's important to keep the CER up to date and revise it as new clinical data becomes available to ensure ongoing regulatory compliance and patient safety.

IZiel provides a unique solution for developing Clinical Evaluation Plan (CEP), and Clinical Evaluation Report (CER) and thereafter provides the physician’s certificate. Our partners have a network of 40+ National Board-Certified Physicians that conduct the risk-benefit analysis and provide the necessary certification.