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DEVICE L❤️VE Live! #5 — 5/14/20

Chatting with Former FDA and Notified Body Representatives
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News

R&Q Experts Reviewed the New MDCG Guidance - Here is What They Learned.

If you were excited when the European Commission finally released four guidance documents covering Clinical Evaluation Equivalence, Clinical Evidence of Legacy Devices, and templates for the Post-market clinical follow-up (PMCF) Evaluation Reports and Plans (MDCG 2020-5-8) last week (23 April 2020), you were not alone! Many of us have been waiting in anticipation for further guidance on how to handle PMCFs and were anxious for further clarification on the expectations of medical device manufacturers in this area. Our team looked into the guidance right away in hopes that we could find some clarification for our clients. As one of our experts put it, however, on the surface this guidance is “clear as mud”. So, we dug into the new guidance and made a table to help make connections for the industry. A few of our overall observations are listed here and check out the table below to dig deeper into each section. • The biggest challenge we see is that because this guidance came so late in the cycle, many manufacturers have been trying to figure out how to comply and move forward for some time now. This leaves many organizations wondering how to use what they have already done and apply the guidance to their completed work. • Additionally, there is continued ambiguity around what to do first, further proving that this is a continuous process and not a linear process. So, where do you start? • We would have liked to see more discussion around risks and benefits regarding the guidance for legacy devices, or better direction pointing manufacturers to the best way to take ownership of this area. • One upside we found is that there is a table for legacy devices that provides a hierarchical appendix for ranking PMCF activities, which is incredibly helpful. Here is a tip from our pros: FDA guidance can be helpful in deciphering the expectations especially around risk-benefit analysis.   REFERENCE TITLE GOOD NEWS WATCH OUTs NOT SURPRISING WAS THIS REALLY NECESSARY? MDCG 2020-8 Guidance on PMCF Evaluation Report Template - The administrative section is a direct copy from the administrative section of the PMCF plan. - You must declare if your device is novel or not; this should match your technical documentation - You need your CND codes; if you haven’t done these yet, it is time - The data from similar devices is required and must include an assessment if this impacts state of the art, identifies new hazards or impacts benefit risk analysis - You need to specifically define how the PMCF report impacts the CER or justify why it doesn’t - You need to specifically define how the PMCF report impacts the risk management or justify why it doesn’t - You will need to include common specifications, harmonized standards and guidance documents utilized for the product; Make friends with Regulatory since they have to do that in the technical documentation MDCG 2020-7 Guidance on PMCF Plan Template - The administrative section is a direct copy from the administrative section of the PMCF plan. - You must define explicitly where the PMCF activity need is coming from (Notified Body request, CER, Risk Management, etc.) - You need to review case reports that may reveal off-labeling usage or misuse as part of PMCF - You need your CND codes; if you haven’t done these yet, it is time - The data from equivalent and similar devices are required and must include an assessment if this impacts state of the art, identifies new hazards or impacts benefit risk analysis - The general and specific methods and procedures PMCF activities need to be included with aim, appropriateness of methods, limitations, and endpoint/deliverable schedule - You need to specifically define how the PMCF plan impacts the CER and risk management report or justify why it doesn’t - You will need to include evaluation of similar and equivalent device clinical data, including CER location in text references and how this data will be used (must match technical documentation) - You will need to include common specifications, harmonized standards and guidance documents utilized for the product MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices - The definitions section includes terms that may not have been defined explicitly in the MDR, expands upon terms and cites where the definitions were derived (MEDDEV 2.7.1 Rev.4, etc.), especially on what “well-established technologies” can include. - Examples of validated clinical data methodological quality assessment tools are provided - Appendices contain modified Clinical Evaluation Plan for Legacy devices and a suggested hierarchy of clinical evidence for confirmation with relevant GSPRS under MDR, depending on the device—a lower level of clinical evidence may be justified - During the period of validity of the MDD/AIMDD certificates, the MDR requirements for the PMS apply from the MDR date of application-- Legacy devices are not exempted from the additional requirements in MDR concerning PMS, including PMCF - Changes in the state of the art, new risks identified via PMS, clinical evidence of devices not sampled prior to application of MDR may not have had Notified Body scrutiny, and more detail required for indications and contraindications may change the clinical evidence needed - Clinically relevant endpoints may be addressed through compliance to product-specific common specifications (device and sufficient clinical data-dependent) - Clinically relevant questionnaires used to bridge gaps with MDR requirements should be scientifically sound and the guidance includes minimum considerations - The MDR has new requirements for equivalence and clinical data, which may reduce data available for demonstration of conformity with GSPRs - You need to conduct a gap analysis for legacy devices per MDR GSPRs, if you have not done so - You need to establish or update a clinical evaluation plan - Compliance to nonclinical common specifications relevant to device safety and performance need to be referenced depending on the device type and sufficient clinical data (these may need to be reference in the PMCF plan and PMCF report) MDCG 2020-5 Guidance on Clinical Evaluation – Equivalence - Differences in equivalence criteria (technical, biological, and clinical characteristic) between MDR and MEDDEV 2.7.1 Rev. 4 delineated and includes explanatory text. - Example considerations of an equivalence characteristic table is included in Annex I (Note: this is not an exhaustive list) - Proper scientific justification for equivalence is needed --devices must have no clinically significant difference in safety and performance between the equivalent and device in-question when used under similar conditions -OR- a description of safety and clinical performance impact must be provided that must be justified. - Clinical data that does not meet the MDR definition cannot be used as clinical evidence to conform with relevant GSPRs. - Pre-clinical data considered for equivalence demonstration should adequately evaluate technical and biological characteristics, and whether differences would result in a significant difference in safety and clinical performance - For products without an intended medical purpose, clinical investigation should be performed unless reliance on existing clinical data from an analogous device is justified—using demonstration of equivalence, demonstration of clinical benefit, compliance to any product-specific common specifications, and demonstrating no clinically significant difference in safety and performance between the devices. - The MDR biological characteristics require assessment of the final product to include factors such as processing or - Principles in ISO 10993 standards can be adopted depending on the biological evaluation necessary for the device. - Equivalence claims cannot be made if a manufacturer cannot demonstrate sufficient access to the presumed equivalent device - Similar device data can be used for risk management (design hazards, clinical risks, adverse events, and acceptable occurrence rates), state of the art, clinical investigation/ PMCF study design, definition of minimum required quantified clinical benefit - Compliance to nonclinical common specifications relevant to device safety and performance need to be referenced depending on the device type and sufficient clinical data (these may need to be reference in the PMCF plan and PMCF report). Make friends with Regulatory since they have to do that in the technical documentation. Have questions? Our remarkable remote support team is available across all R&Q services and we're ready to answer any questions or concerns you have about how to stay on track for the EU MDR timeline. We can help you navigate the difficult road ahead and we have ample virtual content to keep you in the know. Source: European Commission. Docs Room. Clinical Evaluation Equivalence, Clinical Evidence of Legacy Devices, and templates for the Post-market clinical follow-up (PMCF) Evaluation Reports and Plans (MDCG 2020-5-8). Accessed 30 April 2020. https://ec.europa.eu/docsroom/?locale=en 
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News

Q&A: EU MDR Audits: Preparing, Managing & Responding to Nonconformances

R&Q's March 2020 webinar focused on dealing with EU MDR Audit Nonconformances. In this blog post, our knowledgeable EU MDR experts sat down to provide answers to your questions from the webinar and we hope that they will shed some light on similar questions that you may have on the topic. This is only a small sample of the questions that manufacturers currently have around EU MDR audits - and there are sure to be countless others! R&Q is here to help address any other questions that you may have regarding audits or any other EU MDR related topics. Contact us today to find out how we can help! If you were not able to attend this webinar, here's a link where you can sign up to view the on-demand version (and download the slides).
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Webinars

FDA Emergency Use Authorization (EUA) and EU MDR Article 59

26 May 2020 - Processes, tips, and lessons learned.
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MDD

BREAKING NEWS: European Parliament Approves One Year EU MDR Delay

This post is an update to our recent blog post where Nancy Morrison, R&Q's Executive Director, Regulatory & Quality Consulting Services, shared her thoughts on the potential impact of the COVID-19 pandemic on the EU MDR timeline. You can read that post here.
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Quality Management System

Focusing on Process Improvements as a Competitive Advantage

At R&Q, we are seeing firsthand how heavily impacted companies of all sizes are by the volatile global markets brought on by the COVID-19 pandemic. To assist our country’s more vulnerable businesses, the Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed in March, thereby permitting the U.S. Small Business Administration’s (SBA) to initiate the Paycheck Protection Program (PPP). What better use of this program than to spend this time having employees “Sharpening the Saw” while simultaneously gaining a competitive advantage by focusing manpower on improvements and working toward ISO 9001:2015 Quality Management Systems implementation. For some companies, production levels are at a record-breaking high, where others have come to complete halt due to a lack of demand and help is needed now to provide employees with security during the next few months. You should be looking for ways to embrace Stephen Covey’s principle of “Sharpen the Saw”! Companies looking to capitalize on the program can utilize the economic downtime to conduct some “self-care” upon the internal structure of your business. This approach allows your company to maintain a level of employee engagement, while also driving initiatives that will build a competitive advantage within your industry. Now is the time for your company to improve your business processes and bottom-line long term. We recommend strongly considering the immense benefits of implementing the internationally recognized ISO 9001:2015 Quality Management Systems (QMS) program. This program will provide a structured approach to help your team identify critical business processes, document, improve, apply metrics and enable management measurements. The best benefit of implementing this system is, above all, efficiency. Eliminate the areas of your process that cause mistakes, delays, and inefficiencies by training your team on the globally accepted ISO 9001:2015 approach. Do not overlook the opportunity to reengage the workforce on these initiatives – who better to utilize than the small army that you have amassed and trained to understand, build, deliver and/or maintain your product or service? Take the time to reflect, understand and improve your business’ processes and procedures and how they interact throughout the company, in turn leading to increased productivity and improving your bottom line. When the quarantine orders are lifted and your customer orders are piling, you will be steps above the competition with your ISO 9001:2015 Quality Management Systems training in place and ready to make your customers thrilled! Some focal process improvement areas that can be capitalized on are: • Understanding where processing bottlenecks restrict maximizing throughput • Identifying the hidden “rework loops” that are costing extra time and materials • Looking for misaligned or out of control processes that waste raw materials • Conducting past due maintenance to prevent unnecessary downtime Some successful quality methodologies to train upon to maintain positive results: • Value Stream and Process Control Mapping • Design and Process Risk Management • Lean / Six Sigma / 5S Philosophies If you aren’t quite sure where to start or currently do not have the expertise on hand to drive such initiatives in a short time – then do not hesitate to contact R&Q today. We are experts at remote Quality Management and Process Improvement and would love to answer your questions! We can partner with you in excelling your business through: • Customizing a business-balanced approach to full ISO 9001:2015 Quality Management Systems implementation. Any QMS initiative should remain flexible to drive a strategic vision while retaining a positive culture, continual improvement, and factual decision making. • Customizing the facilitation of process enhancements to achieve consistency of a product or service provided and reducing the “decoupling effect” where the established process no longer adequately supports real-time operations. Process gap analysis and data analytics can assist with reengineering procedural concepts and documentation to compliantly realign expectations to real life. • Customized quality initiative training either to support a full ISO 9001:2015 Quality Management Systems implementation or select quality management concepts to assist in driving a quality-minded culture. You can learn more about our Quality Systems services here. Stay safe and productive everyone! We have many free virtual events in the works for this week and beyond! Check them out here and be sure to join us on Friday, April 17 for our first ever DEVICE L❤️VE Live! A new weekly and interactive live show featuring expert panelists discussing hot topics, challenges, and solutions in the medical device industry. This episode will focus on moving medical device manufacturing out of China. Click the button below to learn more and register for free!  As always, R&Q experts are here to help you navigate the difficult road ahead with ample virtual content and remote experts on hand so don't hesitate to reach out to your R&Q representative and contact us today.
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MDD

COVID-19 Continues to Impact Medical Device Manufacturing in China

Medical device companies often have a globally distributed workforce which can include remote specification developers and, more likely, manufacturing sites. In China alone, where the virus was first detected, many medical device companies have manufacturing sites, utilize contract manufacturing sites, and get medical device components – all in China. The disruption in this supply chain will impact device companies and can delay getting devices to customers which can negatively impact healthcare. Realizing the potential impact on manufacturers’ supply chains, the United States Food and Drug Administration (FDA) issued a “Coronavirus (COVID-19) Supply Chain Update” on February 27, 2020 detailing how they are monitoring the medical device industry dealing with the COVID-19 outbreak. To monitor potential impacts including shortages of drugs and medical devices the FDA has set up an email box, deviceshortages@fda.hhs.gov, to enable medical device manufacturers can report shortages. A major concern that has arisen during the COVID-19 crisis is the lack of ventilators available in the US healthcare system to aid COVID-19 patients. To help manufacturers dealing with supply chain shortages of ventilators the FDA issued the policy guidance, "Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency". The FDA hopes that this policy change will create more flexibility for manufacturers that must make device modifications to address current manufacturing limitations or supply shortages. Per the policy, changes to the devices that would normally require a 510(k) will not need to have one submitted for the duration of the public health emergency. Manufacturers must validate the changes to their device and document the change in their device master record and change control records. The policy guidance also describes the FDA's intended approach to Emergency Use Authorizations (EUA) and provides a website and the information requested by FDA to make their determination as to whether an EUA can be issued. Manufacturers who are not currently engaged in medical device manufacturing may also submit for an EUA. FDA intends to work collaboratively with these manufacturers to get through the EUA process.  For example, Ford Motor Company announced recently that it is joining forces with medical device manufacturers including 3M and GE Healthcare to quickly expand production of urgently needed medical equipment and supplies for healthcare workers, first responders, and patients fighting COVID-19. Device manufacturers are also making a positive impact during the crisis by developing diagnostic tests for COVID-19. Multiple In Vitro Diagnostic (IVD) manufacturers are working to develop COVID-19 tests and there are currently multiple test kits on sale that have been made available under CLIA waivers and EUAs with additional testing kits under development. The FDA has relaxed its requirements for CLIA-certified labs and is allowing them to use their test kits without needing to have Emergency Use Authorization. However, the CLIA labs do need to submit an Emergency Use Authorization application within 15 days of validating their new test.[1] BioFire, a division of bioMerieux, has received an EUA from the FDA for a COVID-19 test kit, and Mesa Biotech has received an EUA for their Accula device which is designed to allow for near-patient testing with the results in about 30 minutes[2]. Interested in learning more about this topic? Join us on Friday, April 17 for our first ever DEVICE L❤️VE Live! A new weekly and interactive live show featuring expert panelists discussing hot topics, challenges, and solutions in the medical device industry. This episode will focus on moving medical device manufacturing out of China. Click the button below to learn more and register for free!  As always, if there are questions on the guidelines ask your Notified Body (NB). R&Q experts are here to help you navigate the difficult road ahead with ample virtual content and remote experts on hand so don't hesitate to reach out to your R&Q representative and contact us today.
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News

Join Us Weekly — Announcing DEVICE L❤️VE Live!

The current pandemic is challenging for everyone to varying degrees. R&Q has the utmost respect, appreciation, and love for healthcare workers and all frontline workers across the globe. Our mission from the start has been to improve people's lives and our announcement today has regulatory and quality medical device professionals in mind. There is no better time than now for all of us in and connected to the healthcare industry to be at our best for patients requiring medical care and the healthcare workers providing it. Along with rallying around one another for support, sharing and discussing the latest industry news, regulation changes, pressure points, and potential solutions to problems can be invaluable for us all. Actual solutions are obviously important and our company name isn't Regulatory & Quality Solutions by chance! Those of us not on the frontlines and practicing social distancing (the majority of regulatory and quality pros we know) are also craving connection. FaceTime, Zoom, Houseparty, or whatever your app of choice for connecting with family and friends is great, but what about all those cancelled conferences and networking events? We still need to connect with and learn from each other professionally. For all of those reasons and following in the footsteps of our monthly webinars (which will continue), we're excited to announce a new live and interactive weekly show: DEVICE L❤️VE Live! Show #1 will be next Friday, April 17th. How will it go? Each show will center around a specific newsworthy topic and bring together experienced thought leaders on camera to discuss it. For example, next week we'll discuss moving medical device manufacturing out of China. Weekly topics will be chosen based on what challenges our clients are facing and what our own experts are reading about. The sessions will depend on your questions. We'll bring some client questions to the table and some of our own, but the direction each show takes will be dictated by you. Ask questions live and if fellow attendees want to see it answered by our panelists, they'll be able to easily upvote it. This brings the most popular questions to the top of the list for the moderator to ask the panelists about. Read on for more information on next week's show and subscribe to our blog to learn of the weekly topics.    
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Webinars

RAPS Webcast: PMS Requirements of the EU MDR

  Note: this webcast is now available on demand. R&Q is a Premium Solutions Partner of the Regulatory Affairs Professionals Society (RAPS) and on Wednesday, April 15th, we're joining forces to offer up a premium live webcast. Attendees will earn 1.5 RAC credits and the event is free. R&Q Executive Director of Regulatory and Quality Consulting Services, Nancy Morrison, will be presenting PMS Requirements of the EU MDR: Implementation Challenges and Solutions. This webinar will be an extended, enhanced, and more up-to-date version of R&Q's own February 2020 webinar. An hour and a half has been allotted and Nancy will be taking live questions. This is your chance to get difference-making information from one of the industry's utmost thought leaders and apply it to your own organization.
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News

Q&A: PMS Requirements of the EU MDR

In February – just before COVID-19 began to seriously impact those of us in the United States – R&Q Executive Director of Regulatory & Quality Consulting Services, Nancy Morrison, presented the webinar PMS Requirements of the EU MDR: Implementation Challenges and Solutions. We received a ton of excellent questions during that webinar and in this blog post, we'd like to publicly share our answers to many of them. We hope you find them helpful! If you haven't seen this webinar yet, here's a link where you can sign up to view the on-demand version (and download the slides). If you have specific questions in this area, please contact us.
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Webinars

Structuring PERs under IVDR

Whether you are interested in improved strategies for completing PERs or effectively completing your first PER, our April 2020 webinar can act as a critical guide.
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