#PMCF Includes

[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]

How can medical device companies develop an effective PMCF strategy to meet regulatory requirements?

Developing an effective Post-Market Clinical Follow-Up (PMCF) strategy is crucial for medical device companies to ensure continued compliance and maintain the safety and performance of their products. Regulatory bodies, especially under the European Medical Device Regulation (MDR), require a structured and ongoing approach to PMCF, making it a key element in the lifecycle management of medical devices.

To create a robust PMCF strategy, companies should focus on the following key steps:

Define Clear Objectives: Start by identifying the clinical data needed to address any residual risks and unknowns post-market.

Choose the Right PMCF Methods: Depending on the device, methods could include clinical studies, surveys, or registries.

Data Collection and Analysis: Gather real-world data systematically and analyze it to ensure continuous monitoring of the device's safety and effectiveness.

Update Clinical Evaluation: Use the data collected to update the device's clinical evaluation, addressing any new risks or findings.

For a detailed guide on developing an effective PMCF strategy that aligns with regulatory expectations, check out this insightful blog: High-Level Approach for PMCF Activities. This resource provides practical advice and strategies to help you navigate the complexities of PMCF with confidence.

[marketsandmarkets-events]

Challenges and Opportunities in Europe's Medical Device Regulatory Landscape

The regulatory landscape governing medical devices and diagnostics in Europe is a complex yet crucial framework designed to ensure the safety, efficacy, and quality of products entering the market. This article provides an in-depth exploration of the European regulatory environment for medical devices and diagnostics, highlighting key aspects, recent developments, and the implications for manufacturers, healthcare providers, and patients alike.

Conference Registration for Delegate @ https://bit.ly/3KxKsAp

Regulatory Framework Overview

In Europe, medical devices and in vitro diagnostic (IVD) devices are regulated under separate but interconnected regulatory frameworks: the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). These regulations establish stringent requirements that manufacturers must adhere to before placing their products on the market.

Medical Devices Regulation (MDR):

The MDR, fully applicable since May 2021, replaced the previous Medical Devices Directive (MDD) and introduces more stringent requirements for market access.

It classifies devices into risk-based categories (Class I, IIa, IIb, and III) based on potential risks associated with their use.

Manufacturers must demonstrate compliance with essential requirements, including clinical evaluation, risk management, and post-market surveillance.

In Vitro Diagnostic Medical Devices Regulation (IVDR):

The IVDR, applicable from May 2022, similarly enhances regulatory scrutiny for IVDs compared to the previous In Vitro Diagnostic Devices Directive (IVDD).

It introduces stricter requirements for performance evaluation, clinical evidence, and post-market surveillance to ensure the accuracy and reliability of diagnostic tests.

Key Regulatory Requirements

Both regulations emphasize a lifecycle approach to device regulation, encompassing pre-market assessment, conformity assessment, and post-market surveillance. Key requirements include:

Clinical Evaluation and Performance Studies: Manufacturers must conduct comprehensive clinical evaluations or performance studies to demonstrate the safety and performance of their devices.

Quality Management Systems: Compliance with ISO 13485:2016, a harmonized standard for quality management systems specific to medical devices, is mandatory.

Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF): Continuous monitoring of devices on the market to identify and assess any potential risks or issues is required. This includes reporting adverse events and implementing corrective actions.

Unique Device Identification (UDI): Devices must be labeled with a UDI to enable traceability throughout the supply chain and facilitate post-market monitoring.

Implications for Stakeholders

The European regulatory framework impacts various stakeholders across the healthcare continuum:

Manufacturers: Companies must invest in rigorous clinical studies and compliance measures to meet regulatory requirements, potentially leading to increased time and cost for product development and market entry.

Healthcare Providers: Enhanced regulatory scrutiny aims to improve the reliability and safety of medical devices and diagnostics available to healthcare professionals, thereby enhancing patient outcomes.

Patients: Stricter regulations are designed to provide patients with access to safer and more effective medical devices and diagnostic tests, ensuring their health and well-being are prioritized.

Recent Developments and Challenges

The implementation of MDR and IVDR has faced several challenges, including:

Transition Period: Manufacturers and notified bodies have had to navigate a challenging transition from previous directives to the new regulations, requiring adaptations in processes and documentation.

Notified Body Capacity: There has been a strain on notified bodies responsible for assessing conformity of devices, leading to delays in certification and market entry for some products.

Global Harmonization: Efforts are ongoing to align European regulations with international standards and practices, facilitating global market access for manufacturers.

Become a Sponsor @ https://bit.ly/4aPI4j2

The European regulatory framework for medical devices and diagnostics represents a significant milestone in ensuring patient safety and product quality. While the transition to MDR and IVDR has presented challenges, it also reflects a commitment to advancing healthcare through robust regulatory oversight. Stakeholders must continue to adapt to these evolving regulations, leveraging opportunities for innovation while prioritizing safety and efficacy in medical device and diagnostic developments.

Navigating the European regulatory landscape requires a thorough understanding of MDR and IVDR requirements, proactive compliance strategies, and a commitment to continuous improvement in medical device and diagnostic technologies.

[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.

[cetas-healthcare]

Medtech Market Research

https://www.cetas-healthcare.com/solutions/custom-market-research/

Cetas Healthcare is one of the leading market research firms with an exclusive focus on the medical device industry. The agency has offices in Singapore, the Netherlands, the USA, and India. The company has extensive experience in the cardiovascular space and has prior experience in numerous therapy areas. They offer custom research solutions and Medical Market Research to clients globally. Being a top global medical device company, the company has a team of experts who can help you design and execute your Medtech Market Research! Cetas Healthcare Competitive Intelligence capabilities include a complete suite of competitor monitoring services based on your business requirements. The PMCF MDR help MedTech companies gather, and curate data based on requirements to provide accurate, advanced, and actionable insights.

[ddiclinical]

"MakroCare provides clinical investigation services for new device IDE (Investigational Device Exemptions) studies in different therapeutic areas and full-service PMCF studies. Makrocare provides  end to end  services are  Clinical study project management, competent Authority and Ethics Committee submission and liaison. Regulatory Compliance management for the study.

[iziel-healthcare]

What is Difference between PMS and PMCF?

understanding PMS

· Post-Market Surveillance (PMS) is the systematic process of monitoring the safety and performance of a medical device after it has been placed on the market.

· It involves collecting, analysing, and interpreting data to ensure the continued safety and effectiveness of the device.

· PMS is essential for identifying and addressing any potential risks or issues that may arise once the device is in widespread use.

Exploring PMCF

· Post-Market Clinical Follow-up (PMCF) is a specific type of post-market surveillance that focuses on the clinical performance of a medical device.

· It involves conducting clinical studies or gathering clinical data to assess the device’s safety and performance in real-world settings.

· PMCF is particularly important for high-risk devices or those with long-term implantation to ensure ongoing patient safety.

Differentiating PMS and PMCF

· PMS is a broader term that encompasses all post-market surveillance activities, including PMCF.

· PMCF is a more targeted approach that specifically looks at the clinical aspects of a device’s performance.

· While both PMS and PMCF aim to monitor device safety and performance, PMCF typically involves more rigorous clinical data collection and analysis.

Conclusion

In summary, PMS and PMCF are both crucial components of ensuring the ongoing safety and effectiveness of medical devices.

While PMS provides a general oversight of device performance, PMCF homes in on the clinical aspects to ensure patient safety.

By understanding the differences between PMS and PMCF, manufacturers can implement comprehensive post-market surveillance strategies to meet regulatory requirements and protect patient health.

[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?

[i3cglobalblog]

CER CLINICAL EVALUATION REPORT

The manufacturer of a medical device must produce a clinical evaluation report, CER, to document the clinical evaluation and its result.

 MEDDEV Guideline 2.7 / 1 rev.4 defines clinical evaluation as a procedure that involves the collection, estimation, analysis, and evaluation of available clinical data to support the compliance of the medical device with the Essential Requirements.

 The clinical evaluation report or CER must contain sufficient information to be read and understood by an independent agent. You must provide sufficient detail to understand the search criteria adopted by the evaluators, the available data, the assumptions made, and all the conclusions reached.

 WHAT MUST CONTAIN IN A CER

The report must describe the different stages of the clinical evaluation :

  Stage 0, the scope of clinical evaluation:

- explains the scope and context of the assessment, the technology on which the medical device is based, the conditions of use, and the intended purpose of the device;

- documents any claims made about the clinical performance or clinical safety of the device.

  Stage 1, identification of relevant data:

- explains the literature search strategy;

- presents the nature and scope of the clinical data and relevant preclinical data that have been identified.

  Stage 2, assessment of relevant data:

- explains the criteria used by the evaluators to evaluate the data sets;

- summarizes relevant data sets (methods, results, authors' conclusions);

- assesses its methodological quality, scientific validity, relevance for the evaluation, the weight attributed to the evidence, and any limitations;

- presents justifications for rejecting certain data or documents.

  Stage 3, analysis of clinical data:

- explains whether and the referenced information and clinical data constitute sufficient clinical evidence to demonstrate the intended use and clinical safety of the device under evaluation;

- explains whether adequate data exists for all aspects of the intended purpose.

- describes the benefits and risks of the device

- explains the acceptability of the benefit/risk ratio according to the current knowledge of the state of the art

- identifies residual risks that need to be further assessed during the SMP and PMCF.

 CER CREATION

It is a “live” report throughout the life of the product. Every time new data emerges in post-marketing surveillance (PMS) that may influence the CER findings, it must be modified.

 Evaluators must verify the clinical evaluation report, verify that it includes an accurate statement of their analysis and opinions, and sign the report. 

 They must provide their CV and declaration of interest to the manufacturer. The report must be dated and version-controlled.

[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

[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.