Resource constraints facing global manufacturers are also being felt by Notified Bodies (NBs) across Europe, due to the additional requirements imposed by the new MDR/IVDR Regulations. Team-NB, the European notified body association, issued a position paper to express concerns about lack of resources and guidance to assist in meeting the certification deadlines.
The primary concern cited is that Europe faces a likely device shortagefor patients due to the more complex and longer certification processes required under MDR/IVDR. The demands are too great for the small number of MDR/IVDR designated Notified Bodies (NBs), with only 25 NBs for MDR, and 6 for IVDR, as compared with 51 NBs designated for MDD, and 21 under the AIMDD/IVDD Directives.
Author: Suzanne Broussard, PhD | February 25, 2022
The European Union (EU) saw 2021 bring important milestones and changes to the implementation of Medical Device Regulation (MDR) 2017/745. Key highlights included compliance dates, expert opinion panels, newly published guidance and standards.
MDD Grace Period Extension
The original deadline of 26 May 2021 for MDR 2017/745 compliance has come and gone, and many medical device manufacturers with devices granted a CE mark under MDD are taking advantage of the 26 May 2024 grace period to become fully complaint with MDR. As of September 2021, the EU notified bodies had granted only 502 conformity assessment certificates, thus, it is anticipated there will be an extreme bottleneck in 2023 and especially in 2024 due to limited notified body availability as manufacturers scramble to meet the May 2024 deadline.
At last, common specifications for different groups of products that do not have an intended medical purpose but are covered in the scope of the EU’s Medical Device Regulation, are on the way.
Many devices and substances used for the purpose of aesthetic enhancement have been unregulated, or only partially regulated in the EU and not in all member states.
The New Year has seen the official publication of a series of long-awaited new medtech standards, including some that are critical to large swathes of the medical device industry.
It’s official! The updated version of the EU quality system standard EN ISO 13485, which is relevant for the whole of the medtech industry, is now formally recognized as a “harmonized” standard in the context of the EU’s Medical Device Regulation.
Joining Criterion Edge’s President Laurie Mitchell, is guest speaker, Queenita Fernandes, Medtronic’s Medical Safety Manager, Patient Monitoring & Respiratory Interventions. In this webinar, we discuss how to deploy systematic literature review in order to augment post market clinical surveillance, and share best tips on a robust systematic literature review process. Following this, our guest speaker shares an informative case study illustrating more.
Key Takeaways:
How leveraging published data can help meet regulatory expectations and inform internal decision-making
Steps for conducting a methodologically-sound SLR
How data obtained through SLR can empower the successful execution of post-market surveillance activities, drive efficiencies and support regulatory compliance.
Who Should Watch:
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Clinical Evaluation Reports for EU MDR submission, or anyone interested in learning more about MDR requirements for CERs.
Who are the Panelists?
Laurie Mitchell, President | Criterion Edge
Queenita Fernandes, Medical Safety Manager | Medtronic
The Role of RA in the Clinical and Performance Evaluation Process: Key Strategies to Support Project Success
Scoping Your MDR and IVDR Writing Projects - The Forgotten Step
Ask the Writers: A Comparison of Critical Elements of the SVR versus the CER State-of-the-Art and Best Practice Writing Strategies
[Ask the Expert] Tips For How to Avoid Common Notified Body Review Findings
How to Establish the Competitive Landscape Within the Scientific Validity Report
IVD Deep Dive Series Part 2
Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance
This white paper outlines strategies for the verification of device safety and performance as well as tips to define parameters to determine the acceptability of benefit-risk.
Post-Market Literature Surveillance: Systematic Literature Review and Case Study
[Ask the Expert] Safety and Performance Measures and Acceptance Criteria for MDR
[Ask the Expert] Safety and Performance Measures and Acceptance Criteria for IVDR
[Ask the Expert] Clinical Data for IVD: What Is It and How Do I Find It?
IVD Deep Dive Series Part 1
IVDR Essentials: Performance Evaluation Report - Early Planning and Preparation
How to Establish the State of the Art Within the Scientific Validity Report
How to Establish the State-of-the-Art Within the Scientific Validity Report
Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance
[Ask the Expert] The Importance of Clinical Data: Sources of Data, Literature Searches, Weighting & Appraisal and Effective Presentation in your CER or PER
[Ask the Expert] Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance
[Ask the Expert] Systematic Literature Review: What is it and why is it so important?
How to Establish the Competitive Landscape Within the Scientific Validity Report
[Ask the Expert] Safety and Performance Measures and Acceptance Criteria
How to Establish the State-of-the-Art Within the Scientific Validity Report
[Ask the Expert] Performance Evaluation Report
[Ask the Expert] Performance Evaluation Report
[Ask the Expert] The Importance of Clinical Data: Sources of Data, Literature Searches, Weighting & Appraisal and Effective Presentation in your CER or PER
[Ask the Expert] Safety and Performance Measures and Acceptance Criteria
A Practical Guide: Conducting Systematic Literature Reviews in Support of IVDR Readiness [Free Webinar]
In this practical presentation, Criterion Edge breaks down the steps of the SLR process and takes a wholistic approach to conducting an IVDR-compliant SLR. Using case studies, the presentation illustrates the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR).
Systematic Literature Review: Empower Data-Driven Decisions White Paper
This white paper is a companion piece to our popular webinar where we share our insights on using the Systematic
Literature Review (SLR) to Empower Data-Driven Decisions in your Organization.
Systematic Literature Review: How to Empower Data-Driven Decision Making [Free Webinar]
In this webinar, we share the process of systematic literature review, and discuss the tools and best practices for creating a methodologically-sound systematic literature review.
State of the Art: Building a Solid Foundation for your PER to Support IVDR Readiness
In this webinar, Dr. Sarah Chavez provides an overview of the State of the Art section, and explains how it fits into the overall process of writing a successful, IVDR-compliant Performance Evaluation Report (PER) in a reasonable time frame. A complete readiness assessment and gap analysis will help you identify critical resources, feeder documents, and expertise needed to establish that your IVD may be considered “state-of-the-art.” Ultimately, knowing what the Notified Body expects to see will help you avoid project delays and discover efficiencies in the SOA development process.
A Practical Guide: Conducting Systematic Literature Reviews for IVDR Readiness
This white paper is a companion piece to our popular webinar where we break down the steps of the systematic literature review (SLR) process and take a wholistic approach to conducting an In Vitro Diagnostic Regulation (IVDR)- compliant SLR.
State of the Art: Establishing a Solid Foundation for Your PERs to Encourage IVDR Readiness
This white paper is a companion piece to our popular webinar where we cover the state of the art process and how it
fits into the In Vitro Diagnostic Regulation (IVDR).
Sign Up to be Notified of Our Upcoming Webinars!
Schedule a Free Consult Today!
Fill out this form, or contact us at info@criterionedge.com, and we would be happy to answer any of your questions as well as book you an appointment to discuss your project needs during a time that works for you.
Are You Reg. Ready? Get your medical affairs team primed to manage new regulatory requirements
In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
Effective Corporate Scientific Communications White Paper
This white paper is a companion piece to our popular webinar where we share some of the best approaches we have
discovered for Corporate Scientific Communication Strategies.
Driving Innovation to Success in the Market: Strategic Considerations
In this discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.
Hidden Traps That Will Derail Your PER White Paper
This white paper is a companion piece to our popular webinar that uncovers what we have learned from our experience in writing Medical Device Regulation (MDR)-compliant Clinical Evaluation Reports (CERs), and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER).
Hidden Traps That Will Derail Your CER White Paper
This white paper is a companion piece to our popular webinar where we share some of the biggest issues we have discovered when starting a Clinical Evaluation Report (CER) project, and how to anticipate and avoid project delays.
How to Assess Your CER for MDR-Readiness Part 2
This companion piece to our popular webinar discusses strategies for assessing key components of your CER like clinical data sources and risk-benefit analysis.
How to Assess Your CER for MDR-Readiness Part 1
This white paper outlines strategies to assess your CER including state of the art, safety and performance criteria, equivalence and systematic literature review.
Leveraging the MDR experience for IVDR: Tips for Successful Performance Evaluation and PMS/PMPF Processes [Free Webinar]
Have the IVDR Performance Evaluation and Post Market Surveillance requirements got you tied up in knots? Where do you start? What does the end product look like? We are joined by the VP of Regulatory, Quality, and Clinical from Nextern, a collaborative medical device company bringing unmatched core competence in medical device product design and development. Criterion Edge’s President Laurie Mitchell will lead a discussion of their experiences supporting clients through MDR and IVDR requirements.
Effective Corporate Scientific Communication: Strategies to Support your Corporate Narrative and Maximize the Real-World Impact of your Data [Free Webinar]
In this practical presentation, President Laurie Mitchell will: 1) discuss how an effective scientific communication plan is an important marketing tool for an organization, and 2) present five strategies to ensure your corporate objectives are supported and maximize the real-world impact of your data. Join us to learn how this applies to your organization and how to implement these strategies into your current processes.
Hidden Traps That Derail PER Preparedness: Lessons Learned from the MDR-Compliant CER Writing Experience [Free Webinar]
In this practical presentation, Criterion Edge uncovers what we have learned from our experience in writing MDR-compliant CERs, and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER).
Hidden Traps That Can Derail Your CER: Answer These Critical Questions Before You Start Writing [Free Webinar]
As we all know, the MDR has significantly increased both the quality and quantity of inputs needed to complete a CER, needing more up-front planning than the reports have in the past. Based on our experiences with clients both large and small, our President, Laurie Mitchell, shares some of the biggest issues we have discovered when starting an MDR CER project. Laurie also reveals some of the most successful strategies in addressing these issues, up-front and early.
How to Assess Your CER for MDR Readiness, Part 2 [Free Webinar]
In this second installment of our 2-part webinar series, Criterion Edge shares practical presentation to help you assess your CER through the critical lens of a writer and identify possible gaps for mitigation before prior to submission to regulatory authorities.
Systematic Literature Review: How to Empower Data-Driven Decision Making [Free Webinar]
In this webinar, we share the process of systematic literature review, and discuss the tools and best practices for creating a methodologically-sound systematic literature review.
Experience and Scalability
Watch this video to learn how Criterion Edge is different from the rest.
5 Key Questions to Help Manage Your Budget
This infographic goes through 5 key questions to go through in order to control your budget.
Examining the Implications of the MDR on Data Management
Leading industry experts come together to discuss how the MDR affects data management within their respective units.
MedDev 2.7/1 Guideline: Equivalence and Risk/Benefit Profile
This report clarifies the modifications to the equivalence guidelines in MEDDEV 2.7/1 and Quality Management Systems (QMS) ISO 13485 standard to help develop strategies.
MedDev 2.7/1 Guideline: Qualifications of Evaluators and Scientific Validity
This gap analysis addresses key revisions to evaluator qualifications and scientific validity in the Clinical Evaluation (CE) MEDDEV guideline rev.4.
MedDev 2.7/1 Guideline: More Clinical Evaluations?
The changes to 2.7/1 rev. 4 suggest the need to submit more frequent CERs to regulatory authorities, however, strategies will be discussed for managing the increased requirements.
Data Mining: New Initiatives on Health Care Data that Manufacturers Should be Watching
Every time a healthcare provider makes a notation in the medical chart, a significant and valuable piece of data has been created. This paper discusses the implications of this.
10 Strategies to Build Efficiencies in your Regulatory Writing Process
This piece discusses 10 key strategies to building an efficient regulatory writing process.
State of the Art: Best Practices and Literature Review Using DistillerSR
In this paper, we discuss a prominent clarification on the MEDDEV 2.7.1 rev 4, establishing the “state of the art” section.
Q&A Follow-Up: How to Assess Your CER for MDR Readiness, Part 1 [Free Webinar]
The overwhelming turnout at the ‘How to Assess Your CER for MDR Readiness, Part 1’ prompted us to host a live Q+A session where President Laurie Mitchell exclusively answers all your questions.
Systematic Literature Review To Help Meet MDR Requirements [Free Webinar]
President Laurie Mitchell returns to continue sharing more about the importance of the systematic literature review.
State of the Art Literature Review for EU MDR Compliance: How To Get It Right [Free Webinar]
Establishing and defining state of the art for a medical device is no longer an isolated task – it supports the entire Clinical Evaluation Report (CER). Multiple sections of the MEDDEV 2.7/1 rev 4 compliant CER need to be supported by state of the art data, including safety and performance, risk management, and equivalence.
How to Assess Your CER for MDR Readiness, Part 1 [Free Webinar]
In this first installment of a 2-part webinar series, Criterion Edge will present strategies for assessing key components of your CER (or CER template) for possible misalignment with significant and applicable MDR requirements.
Intro to Adverse Event Reviews [Free Webinar]
In this webinar, President Laurie Mitchell discusses why safety reviews are essential in the entire life cycle of product development.
Advantages to Technologies Supporting Endpoint Adjudication [Free Webinar]
Kyoko Hattori from Criterion Edge returns to discuss best practices for managing the adjudication process in-house, and Brian Kelly from AG Mednet will share how the “JUDI” platform can simplify the management of adjudication.
Endpoint Adjudication by the Clinical Endpoints Committee (CEC) [Free Webinar]
In this webinar, learn about CECs, familiarization with regulatory guidance, decision factors leading to use of a CEC, and much more.
Privacy Overview
This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.
Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.
If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.
3rd Party Cookies
This website uses Google Tag Manager and Pardot's tracking features to collect information such as the number of visitors to the site, and the most popular pages. Keeping this cookie enabled helps us to improve our website.
Please enable Strictly Necessary Cookies first so that we can save your preferences!