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News | EU MDR

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 | Webinars

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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MDD | News | EU MDR

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 | News | ISO 9001:2015

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 | News | EU MDR

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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MDD | News | EU MDR

How Will COVID-19 Impact the EU MDR Timeline?

Nancy Morrison, R&Q's Executive Director, Regulatory & Quality Consulting Services, shares her thoughts on the potential impact of the COVID-19 pandemic on the EU MDR timeline: Team NB, the European Association of Notified Bodies (NB) that are active in the medical device sector, released a short statement on March 12 discussing the anticipated impact of COVID-19 on the Notified Bodies. See their statement here. Per the statement, the outbreak and associated travel restrictions are affecting the Notified Bodies’ ability to conduct both Medical Device Regulation (MDR) audits and surveillance audits to existing directives. Team NB assures readers that the Notified Bodies are discussing contingency plans with the competent authorities to work through the issues ahead. R&Q Subject Matter Expert Dr. Ibim Tariah, Vice President of EU MDR and IVDR Consulting Services, says that given the ripple effect COVID-19 has already had on medical device global business capabilities, travel and the workforce, we may see an impact on the MDR timeline and especially the upcoming May 26 date of application. We see that COVID-19 is having a ripple effect through the MDR certification process and may continue to do so for years ahead. At this time, only 10 Notified Bodies (out of 56 MDD designated NBs) have been designated to the MDR to date. Additionally, COVID-19 is further reducing the European Union competent authorities’ ability to conduct the necessary activities to designate additional Notified Bodies. COVID-19 effects of travel restrictions, reduced workforce, and the lock down in Italy have enormously compounded an already challenging endeavor for the competent authorities to designate more NBs in a timely manner. As a result, a heavy workload concentrated to a small number of NBs leaves many manufacturers with undesignated notified bodies at a loss for a path and the necessary guidance to MDR certification. Current Notified Bodies certainly have the capability to conduct some audit activities remotely, but there are portions of the conformity assessment process, such as verifying manufacturing processes, that must be done at the physical manufacturing facility. There is a requirement of some amount of on-site work that is required prior to issuing CE certificates and due to social distancing measures being put in place across the globe, it is difficult to know when these necessary audits will resume. On the other hand, even if the Notified Bodies were able to travel, medical device manufacturers are working through the enormous challenges of a reduced workforce imposed by COVID-19 limitations. Of course we must mention the manufacturers that work with a critical supplier or manufacturing site in China experiencing additional barriers to successful audits – and that’s a topic that requires an entire post of its own! Despite no official word from the European Commission on an EU MDR date of application extension at this time, we believe that these external influences caused by COVID-19 may result in the reconsideration of the date of application on May 26, 2020. It will take an act of Parliament to change the date of application, advised by the European Commission which could result in another corrigenda being published, such as when Class 1R devices were delayed. In the past, we have seen other EU regulations extended or partially extended at the last minute. In 2016, for example, the EU Commission delayed the date of applicability for the PRIIPs Regulation (financial disclosure) by one year. The statement was issued November 6, 2016 extending the date of applicability until January 1, 2018, which was only seven weeks before the due date. As with so many important decisions during this challenging and uncertain time, it is difficult to predict what the extension might be, if any. A reasonable request from industry would be an extension to existing certificates in an abbreviated fashion. Currently, however, there are only rumors and no official statements from the Commission committing to such an extension. In fact, they just released new guidance this week – see our blog post here. We believe a change will be difficult and if it happens it will occur in the final hour. R&Q experts are advising manufacturers to keep working on compliance to the target dates even though the virus may be the final straw needed to push the Commission to act. In the meantime, 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.
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MDD | News | EU MDR

New EU MDR Guidance on Significant Changes

As most of the world seems to be at a standstill this week, the European Commission published new guidance (MDCG 2020-3) to further define “significant change” requirements under the new Medical Device Regulation (MDR) policies coming our way on May 26, 2020. The highly anticipated guidance provides medical device manufacturers and Notified Bodies (NB) with flowcharts to determine if devices currently covered by certificates under Medical Device Directive (MDD) or the Active Implantable Medical Device Directive (AIMDD) should consider a change in their medical device as significant when transitioning to MDR under Article 120(3). R&Q experts found that the new flowcharts are helpful in terms of identifying which medical devices would qualify as a significant change, though the guidance would benefit greatly by providing specific examples of changes to help interpret the flowcharts. The European Commission reiterates that no new certificates will be issued as a result of changes and that the Notified Bodies (NB) may choose to assess a change and, subsequently, issue a letter that will document that the change was not deemed a significant change. Manufacturers are then required to maintain the letter. According to the new diagrams, the EU MDR transitional provisions consider significant changes as: Chart A: Change in the intended purpose o Extension or change in intended purpose o New user or patient population o Change of clinical use (e.g. new anatomical site) Chart B: Change in design or performance specification o Needs new clinical data to support o New risks that require control measures o Change in built-in control mechanism, operating sources, source of energy or alarms Chart C: Software chart o New or major change to operating system o Modified architecture or database structure, algorithm o User input replaced with closed loop algorithm o New diagnostic feature or new channel of inter-operability o New user interface o Not a minor change Chart D: Change in material o Change includes human/animal origin o Medicinal substance impacted by change o Ingredient from new supplier with new specification Chart E: Change in sterilization or packaging design that impacts sterilization o New sterilization method o Design change impacts sterilization o Package design impacts sterilization o Extension of expiry without prior NB review of methodology Meanwhile, the following changes are considered acceptable under the transitional provisions: - Change in Authorized representative - Change in manufacturers name, address or legal form (legal entity remains) - New manufacturing sites - Subcontractor, supplier changes - QMS changes (with limits) - Software o Correction of an error with no safety risk o Appearance of the user interface o Enhancements in user interface 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 experts on hand so don't hesitate to reach out to your R&Q representative and contact us today.
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MDD | News | EU MDR

EU MDR 2017/745 Health Check List

Check out R&Q experts' European Union Medical Device Regulation (MDR) 2017/745 Health Check List below to determine the areas to focus your resources in the final few months before the May 26, 2020 MDR Date of Application. If you have questions, concerns, or need any help identifying the areas to prioritize, don't hesitate to reach out to your R&Q representative or contact us today. 1. Be realistic about where you are in the EU MDR transition process and use the resources available to you – we have many listed below! a. Medical device manufacturers and Notified Bodies alike are being stretched thin, so the sooner you can identify what needs to be done the better – time is not on your side. 2. Know your Notified Bodies. a. See a current list at the bottom of this article or conduct your own search here. 3. Do not underestimate the application process – it is very intense! a. You are required to have level 6 CND codes if available, materials and primary function of devices to be identified. Note that CND codes are the product codes used under EU MDR, replacing GMDN as common nomenclature. You can reference the guidance on CND codes here.  b. Expect an average of three rounds of questions for companies with complex product lines. 4. Initiate scheduling for your initial Quality Management System (QMS) audits ASAP. a. Audits are taking at least six months to be scheduled AFTER the application is accepted by the Notified Bodies and a contract is in place. b. Anticipate much more stringent audits on clinical data, consequently you need to focus on closing any clinical evaluation gaps as well as your Post Market Clinical Follow-ups (PMCF). 5. Prioritize completing your Post Market Surveillance (PMS) plans, including PMCF plans, as they must be in place for all devices. a. Although we always recommend full compliance, this is an area that we see many clients struggling due to the depth of new requirements and vague guidelines. Your R&Q representative can help you determine the next steps based on your unique needs. b. Check out our free webinar on PMS Requirements of the EU MDR: Implementation Challenges and Solutions here for additional in-depth information on this topic. 6. Full EU MDR compliance is required if you have Class I devices that are not sterile, measuring or reusable surgical instruments. Full compliance is also required for custom Class III devices. 7. Vigilance reporting needs to follow EU MDR’s 15-day reporting timeline. 8. Registration was due but with the delay in the EUDAMED database to at least 2022, we are following MDD registration. Stay tuned for more guidance for Economic Operators/Manufacturers. a. Check out our blog post on the EUDAMED delay here. 9. No new devices or significant changes in design or intended purpose. a. For example, if you have a certificate for Class IIa devices in a certain family you cannot do a line extension after May 26, 2020 without an MDR certification. 10. The good news is that Class I reusable surgical instruments have been extended to May 26, 2024 for compliance, though they must be on an MDD Declaration of Conformity and meet the "no changes" statement above. a. Be aware of the Implant Card guidance as it now requires a credit card size per ISO/IEC 7810. b. Read our blog post about the EU MDR Class I device delay here. 11. Anticipate that new test results on legacy devices may result in a failure – so do not assume that doing testing for your legacy devices will get supporting evidence of safety/performance. 12. For United Kingdom distributed devices: a. Brexit has happened but not in the “hard Brexit” format that we feared last year. Read our blog post on Brexit: Top Five Do's and Don'ts for Medical Device Manufacturers here. b. It is time to find a new authorized representative now, since transition planning is in process and the current date is December 31, 2020 for the exit. 13. For Switzerland Notified Bodies and manufacturers: a. Contingency plans may be required as Switzerland still has not completed the mutual recognition with the EU. If you are struggling with the above items or having any other issues or concerns with your EU MDR transition, don't delay in contacting your R&Q representative - we are here to help!  Below are the current designated Notified Bodies for EU MDR pulled directly from the European Commission Internal Market, Industry, Entrepreneurship and SMEs Notified bodies Nando tool that can be found here.
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MDD | News | EU MDR | Brexit

Brexit: Top Five Do's and Don'ts for Medical Device Manufacturers

After four years, many heated debates, several delays, and a few Prime Ministers later, the United Kingdom (U.K.) is officially leaving the European Union (EU) today, January 31, 2020. Well, sort of. Instead of the “hard Brexit” that had been promised and feared in March, April, and October of 2019, we will instead be entering this phase with a much-welcomed transition timeframe. The current transition allows for most things to remain the same for medical device manufacturers until December 31, 2020. During this transition year, you can continue to utilize U.K. based authorized representatives, European Union Notified Bodies, and sell CE marked devices that meet the EU medical device requirements including both Medical Device Directive (MDD) and Medical Device Regulation (MDR) compliant devices. The most immediate change that occurs as of today is that the 73 U.K. parliamentarians from the 751-seat legislature will exit the EU, meaning the U.K. will no longer be part of the on-going legislative processes. The U.K. will also lose the ability to take the lead on reviews, so if you have a medical device with an integral medicinal substance, the Medicines & Healthcare Products Regulatory Agency (MHRA) will not be allowed to take the lead on that review. They may be able to participate on various committees but will have no voting rights. As we learned from EU MDR, time flies not only when you’re having fun, but also when you’re in a regulation transition period – and trust us when we say that December 31 will be here before you know it. For device manufacturers, here are the top five DO’s and DON’Ts to ensure an on-going ability to distribute your product in the EU: DO transition to an EU authorized representative if you currently have one in the U.K. You will need to register your class I devices that were previously with MHRA with the new Competent Authority based on the location. DON’T underestimate the time it takes to get a new Notified Body. If you have a U.K. Notified Body and have not yet transitioned to another office, the time is now to begin that process. With EU MDR implementation, the lead time to get a new NB is extensive. DO get yourself an EU importer, if applicable. If you are using a U.K. based importer, you will need to arrange for an importer that is part of the EU. DON’T wait to review and modify your contracts. If you need to modify your contracts with your NB and/or economic operators as part of Brexit, now is the time to make sure they are in alignment with the EU MDR requirements which is required by May 26, 2020, even if you are using the MDD soft transition period. DO sign up for e-mail notifications from the U.K. on the transition process. And then actually open and read them when they hit your inbox! Once you have taken care of making sure that you can continue to sell devices in the EU, you also have to consider what is required to continue to sell devices in the U.K. since this is now an independent nation with their own set of rules. As transition and trade deals are still in progress it is hard to define exactly what may be required. Luckily, there is guidance around a hard Brexit which provides some insight into how things may change moving forward: • Potential U.K. responsible person with an address in the U.K.; note that at this time this name does not have to be added to the label. • Separate registrations with MHRA; make sure you have a staff member identified to complete this requirement and watch the dates carefully. • Continue to monitor guidance that are expected to be updated to reflect the transition negotiations as they occur. We know that adding the Brexit transition timeline to your already full plate seems daunting but fear not! Along with your MDR transition, this too can be managed smoothly if you plan carefully and use the resources available to you to meet all new requirements. As always, R&Q experts are just a call or e-mail away if you have any questions or concerns about your company’s ability to stay on top of the ongoing changes in the European Union.
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Events | Minnesota | Medical Alley

POSTPONED: Strategic Solutions for EU MDR Workshop – Minneapolis

March 12, 2020 — Minneapolis, MN
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Events | Boston | massmedic

POSTPONED: Strategic Solutions for EU MDR Workshop – Boston

March 10, 2020 — Boston, MA
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News

MDR’s May 2020 Deadline Won’t Change

During a December meeting of the European Union’s Employment, Social Policy, Health and Consumer Affairs Council (EPSCO), European Commissioner for Health and Food Safety, Stella Kyriakides, confirmed that the May 2020 deadline for Medical Device Regulations (MDR) implementation will not change. See the recording of the December 9 public session with comments from representatives across the EU (beginning around 1:37) here. Commissioner Kyriakides brief comments begin around 2:09:10. Below are highlights from the session and few of our takeaways from the impending deadline: The May 26, 2020 Date of Application of the new regulation remains unchanged despite the EUDAMED database delay. 700 experts have applied to serve on the new medical device expert panels. A key pre-requisite for some implantable - & Class III - devices and Article 12 devices (Class IIb devices that channel medicines to or from the body) that may be subject to Clinical Evaluation Consultation Process (CECP). The postponement of the EUDAMED database does not impact the application of the regulations. In other words, the EUDAMED delay should not be used as an excuse for manufacturers not to comply with the MDR. Another three Notified Bodies (NBs) were expected to be designated before the end of 2019. Assuming a maximum of ten NB’s were designated under the MDR by 2019 year-end, this is still well short of the 20 promised by the EU Commission in 2019 and significantly less than 56 NB’s currently designated under the MDD. This implies that NB’s will continue to be overloaded for the foreseeable future and will be less tolerant of Technical Documentation submissions that are deemed to be “non-compliant”, more so, with the capping of rounds of Q&As. Given the inescapable tug-of-war between medical device manufacturer's competing business priorities, we strongly encourage you to act quickly and not to wait until May 2020 to start scrambling. The new MDR requirements take time, resources, and a lot of planning so most organizations need outside support to structure the transition in alignment with their business goals. As always, R&Q will continue to work closely with our clients to ensure that Technical Documentation submissions are Notified Body (NB) compliant. In the meantime, we encourage our clients to reach out to their R&Q account contact to discuss their MDR transition plans.
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News

House Passes Bill to Repeal the Medical Device Tax

The holidays may have just gotten a little happier and a lot brighter for those of us in the medical device industry! Earlier this week, the U.S. House of Representatives passed legislation to repeal the impending and much-criticized Medical Device Tax, a 2.3% excise tax on sales of medical devices in the United States. Originally implemented in 2013 as part of the Affordable Care Act, the tax was slated to come back into effect as of January 1, 2020. In an exciting turn of events, the U.S. Senate is expected to pass the repeal over the next several days, where it would then be sent to the President for signature, sending the tax repeal into effect permanently. If not repealed, the 2.3% Medical Device Tax would have far-reaching and stifling negative effects for the medical device industry. We could expect a significant financial impact on bottom lines, consequently shrinking profit margins, Research and Development (R&D) spending, and operating budgets. It would also have an enormous impact on our patients globally, as the tax takes away dollars from R&D spending, resulting in less innovation and slowed down the delivery of new device advances into the market. According to the Advanced Medical Technology Association (AdvaMed) and a report published recently by the Tax Foundation, there is potential in 2020 for a loss of over 21,000 full-time medical technology jobs if the tax is not repealed. On the other hand, a repeal would likely stimulate the creation of new jobs as it frees up investment funding for product innovation. When R&Q experts consider the immediate impacts of the likely repeal of the Medical Device Tax, we anticipate an opportunity for our clients to have more funding available to support the compulsory transition of their products to meet the new European Union Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), which come into full effect May 2020 and May 2022, respectively. As many in the medical device industry know, the looming MDR and IVDR transitions have us facing enormous hurdles that impact patients as well as our clients’ quality systems, product approvals, product registrations and the addition of clinical and post-market surveillance (PMS) requirements that did not exist before. The new requirements also have significant impacts on product development, clinical affairs, quality and regulatory affairs functions which need to invest time to complete the required transitions. As a full-service medical device, combination product, and IVD consultancy, R&Q has the experience and resources your company needs to tackle the EU MDR & IVDR transitions, as well as drive product innovation with additional funding freed up by the potential permanent repeal of the Medical Device Tax.
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News

R&Q Cares: Supporting Light of Life Rescue Mission

The R&Q offices are buzzing with excitement as the holidays quickly approach! Many of us are preparing to gather with family and friends this week to celebrate Thanksgiving over a warm meal, football on the TV and great conversation with loved ones. As much as we are a company that loves to celebrate, we equally love to give back to those who really need our help. According to the January 2019 Allegheny County Annual Point-in-Time Homelessness Count, 774 men, women and children were identified as homeless in the Pittsburgh, Pennsylvania area, 73% of whom required emergency shelter at the time of the count. The night this count was taken, the temperature dipped to -5°F. Many of us consider ourselves fortunate that we cannot imagine sleeping outside when the winter air is so cold, but unfortunately this is the life-altering reality for many individuals and families across the country.
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News

EU MDR/IVDR Guidance List Provides Insight on 2019 Expectations

Get ready for an active fourth quarter in the European Medical Device Regulation (MDR) world! We sat down with R&Q's Nancy Morrison, Executive Director of Regulatory and Quality Consulting Services, to get her thoughts on the newly released "Ongoing Guidance development within MDCG Subgroups" document from the European Commission. According to the list published on October 25, there are 18 deliverables still planned for the remainder of 2019 that should provide more information on how the MDR will be implemented. There are, however, still some important topics that appear to be in the early stages such as the definition of a significant change and post-market surveillance (PMS) requirements where a task force still needs to be established. Additionally, one significant missing item that would be especially helpful to R&Q Solutions clients is a template for the creation of Periodic Safety Update Reports (PSUR). As we gain experience in creating EU MDR compliant quality systems and technical documentation these guidance documents will provide a valuable check to ensure our work to date has been meeting the intent of the regulation. It always feels good to get validation for all the hard work that has gone into getting ready for May 2020! Here is what we can expect regarding EU MDR & IVDR guidance in the last two months of 2019: - Template PMCF Plan - Market Surveillance for Class I devices - Clinical evaluation of software - UDI: Integration with QMS, Guidelines on specific product types (working with the US), formats of AICD and HRI parts of UDI Carriers - Classification of IVDs - Nomenclature: Information package on EMDN for a website, list of EMDN codes for implant cards - Multiple clinical investigation guidance documents
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News

Q&A: FDA Updates for Medical Device Manufacturers

From new software and cybersecurity guidance to updates to existing medical software policies, September was a busy month for FDA guidance releases. During our October webinar on FDA Updates for Medical Device Manufacturers, R&Q experts addressed these changes and what impacts our clients should expect. We focused on what is new, notable, and necessary for medical device manufacturers, particularly items that we anticipate will have the biggest impacts on the medical device industry. Here are the areas that our experts think you should be paying attention to right now: the FDA’s two-phase Breakthrough Devices Program, the Medical Device Development Tools (MDDT) originally piloted in 2013, expected changes during the CDRH Reorganization, harmonization and modernization of the Quality System Regulation (QSR) 13485:2016 for medical devices, and the safety and performance-based 510(k) regulatory clearance pathway.
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Events

RAPS Atlanta Chapter: Brexit and EU MDR – Are you Ready?

November 21, 2019 — Alpharetta, GA
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