Browse by topic
Subscribe to our news

EU MDR

A Quantitative Approach to Benefit-Risk Determination

Under the Medical Device Regulation (2017/745) (MDR), demonstrating clinical benefit and quantifying benefit-risk ratios are critical to compliance. A medical device must not be placed on the market if the benefit of the product does not outweigh the risk in a clearly quantified and documented benefit-risk analysis. Qualitative arguments are inherently subjective to some degree – an issue that can be addressed by a quantitative approach.
Read Now

IVDR | EU MDR

MDR and IVDR Mock Technical Assessments and Design Examinations

— coauthored by Amie Smirthwaite, BEng, Ph.D., SVP, Intelligence & Innovation and Carlos Galamba, BSc, MSc, VP, Intelligence & Innovation - IVD With the rollout of EU MDR and IVDR, manufacturers are facing new challenges, especially when it comes to technical documentation review. Medical device and IVD manufacturers are accustomed to doing mock audits for quality systems and ISO certification, but these types of assessments are a relatively new concept in the regulatory realm. 
Read Now

Medical Devices | EU MDR

Impact of of MDCG 2021-24 on the Classification of Spinal Implants

The recently released guidance on classification of medical devices is very concerning for manufacturers with spinal implantable medical devices. MDCG 2021-24 appears to have classified many spinal fusion devices that were previously thought to be Class IIb as Class III. This means a more intense application process, closer scrutiny from notified bodies, and a significant resource investment into reclassification.
Read Now

EU MDR

Is Your Medical Device a Well-Established Technology (WET)?

As guidance committees, manufacturers, and notified bodies continue to interpret the EU MDR, some areas remain fuzzy. Well-established technology (WET) is high on the list of definitions that are disputed as notified bodies seem to have a different interpretation than the guidance document. This puts manufacturers in the difficult position of having to decide whether a device is a WET and defending that stance to notified bodies.
Read Now

EU MDR

RQM+ Case Study: Effective Managed Outsourcing for EU MDR

THE PROJECT A leading global company offering medical technology, services, and solutions engaged RQM+ to help four business units prepare for the EU Medical Device Regulation (MDR). Specifically, RQM+ is focused on assessing and remediating gaps in MDD technical files and building compliant MDR technical documentation files for submission.
Read Now

MDR | EU MDR

The EU MDR Date of Application Has Arrived!

The European Union (EU) Medical Device Regulation (MDR) 2017/745 date of application is here! To celebrate the incredible effort medical device manufacturers have put in so far to get to this point, we have compiled a brief review of the remaining EU MDR timeline and a list of brand new educational content brought to you by RQM+ subject matter experts. 
Read Now

MDR | EU MDR

Optimizing your Technical Documentation to reduce NB review time and questions (Medical Devices and IVDs)

Whether you are used to working with a notified body or the MDR/IVDR requirements no longer allow you to self-certify and it’s all new to you, it is more important than ever to optimize your technical documentation. Notified bodies are already swamped with MDR submissions, and as the IVDR deadline approaches and new manufacturers engage them, the bottlenecks will get even tighter for IVD NBs.
Read Now

EU MDR

State of the Art (SOTA) Part I: What is a State of the Art Evaluation?

You have been reviewing the 4th revision of the European Commission’s Guidelines on Medical Devices, "MEDDEV 2.7/1 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC" to make sure you are following all requirements to get (or keep) your medical device on the market in the European Union (EU). The term “state of the art” is mentioned 39 times throughout the document, but what exactly does the European Commission mean by it and what are you supposed to evaluate according to the guidelines? We are glad you asked! In this two-part series, we will start by reviewing what state of the art really means in the EU’s medical device guidelines and what their objective is in using the phrase. What is state of the art? Although state of the art is commonly defined as the newest idea or newest feature, state of the art in relation to European Commission regulations for medical devices does not imply the most technologically advanced solution. First mentioned on page 9 of the MEDDEV 2.7/1 guidance document, state of the art in this context refers to the current state (or current knowledge) of comparable treatment options. Another way to think of it is by asking “what is currently and generally accepted as good practice?” Moreover, the "MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies" gives a definition of state of the art as:
Read Now

News | FDA | EU MDR

Emergency Use Authorization Stories: The Humn Project

As we collectively watch the world struggle to cope with the devastating impacts of COVID-19, the Emergency Use Authorization Act has given the R&Q team opportunities to provide pro bono regulatory guidance to incredible medical device companies that are prioritizing “giving back” to the communities that desperately need the help. --------- The Humn Project During our recent R&Q DEVICE L❤️VE Live!, our subject matter experts discussed the use of the U.S. Food & Drug Administration’s (FDA) Emergency Use Authorization (EUA) process and E.U.’s Medical Device Regulation (MDR) Article 59 to release medical devices needed for the COVID-19 Public Health Emergency.  Check out the on-demand recording of this show here. The U.S.’s EUA allows medical devices that are uncleared or unapproved by the FDA to be used during a national health emergency, in this instance to help prevent the spread of COVID-19. The EUA process is enabled by a Declaration of a Public Health Emergency by the U.S. Department of Health & Human Services (HHS). This process allows for manufacturers of necessary medical devices, in vitro diagnostic devices (IVD), and pharmaceuticals to request an expedited and interactive EUA review to address unmet needs during a health emergency, as we have seen at the global scale during the current COVID-19 pandemic.  This is where Daniel Clark, President of Linear Health Sciences, an Oklahoma-based medical device company and a longtime client of ours, comes in. Typically specializing in the development of products for various types of medical tubing based on proprietary, breakaway safety-valve technology, Clark partnered with his twin brother and younger sister to found the benefit organization, The Humn Project, to develop a UV-C disinfectant light to combat the spread of the devastating virus with a focus on human safety while using the device. “Thanks to the incredible work R&Q has led, we're in a great position currently looking forward to making a fundamental impact on the war against this invisible enemy.” – Daniel Clark, The Humn Project When R&Q heard that Clark and his team were working to bring an open-source, not-for-profit medical device to help prevent the spread of COVID-19 through the EUA, we knew we had to use our team’s expertise to help their efforts at no expense. To assist the project, our team developed a Regulatory Strategy for the device's EUA submission to support labeling and testing plans by compiling and drafting the pre-EUA submission, serving as Regulatory Correspondent with the FDA, and planning to compile the EUA submission in the near future.   We are proud to support remarkable organizations like Humn Project because it is in R&Q’s blood to want to improve the lives of others and we love to back people making a difference in our communities. As Andrea Clark, Marketing and Commercial Partner of Humn Inc., stated: “Humn Project was built out of this need to strengthen public health by building essential products to benefit society at-large. With no other competing interests, Humn Project recognizes inherent disparities within public health and we are working to even the playing field. Currently, this work includes a novel FAR-UVC disinfectant lamp that reduces the spread of germicidal spores. Working with multiple partners, from engineers and testing experts to the R&Q Regulatory experts, we are expediting our MCM through EUA to get this into clinical essential workers’ facilities as quickly as possible." By providing pro bono regulatory support with the EUA process to obtain FDA authorization for Humn Project, R&Q hopes to support its incredible mission and get the device to market quickly and safely. Brian Clark, Humn’s Managing Partner, reiterates the urgency of getting this technology into the hands of those that need it: "Our mission at Humn is to create open-source technology-driven solutions that positively impact communities with efficient scale. We are a benefit organization, and our first opportunity is to commercialize the promising research on the use of Far-UVC as a germicidal disinfectant. Unlike traditional germicidal UV lamps, research indicates this form of UV light can destroy viruses and bacteria, yet still operate safely around humans. The Far-UVC product that we're bringing to market provides direct support for our communities and front-line workers, and benefit the broader health outcomes of our communities." Want to learn more about this topic? Join us on Tuesday, May 26 for R&Q’s May Webinar on the FDA Emergency Use Authorization (EUA) process and EU MDR Article 59 to release devices needed for the prevention and treatment of COVID-19. In this free webinar, we will discuss both emergency application processes, provide answers to the many questions we have received, and share tips and lessons learned from our experiences. Click the button below to learn more and register: If you are looking for help with EUA or other regulatory needs, check out our Regulatory Services page here and contact us today! 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: FDA Emergency Situations Medical Devices. Accessed 11 May 2020. https://www.fda.gov/medical-devices/medical-device-safety/emergency-situations-medical-devices. 
Read Now

News | EU MDR

RQM+ Remediation Station: Tools & Tips

Welcome to the Remediation Station! We've got live shows with the experts, case studies, and insights to help you get through remediation successfully.  First up, join us Friday, May 8 11:00am ET / 8:00am PT for Device Love Live #4: Best Practices for Reducing Pain in a Medical Device Remediation Program. Our subject matter experts are talking about remediation programs at medical device companies. DHF and manufacturing remediation resulting from government actions (FDA warning letters, EU's non-compliance reports) are the extreme and we know that the proactive efforts needed for many companies to achieve MDD compliance let alone the jump to MDR are no piece of cake either.   Remediation often exhausts the team, brings down morale, and leads to much debate over what is "good enough".  Let's talk about best practices to enable remediation efforts to be as pain free as possible. Join us for free by clicking the button below: Keep reading for more insight on the remediation process and what your company can do to improve your success: When do medical device companies need remediation? The need for remediation efforts at a company can be generated for a multitude of reasons. Most often it is the result of an FDA inspection or Notified Body audit that has identified numerous non-compliances. Preferably, internal audits identify areas to focus on proactive remediation efforts to avoid regulatory body findings. Established device companies typically have known deficiencies that need to be rectified or holes that need to be patched in Design History Files (DHFs), Technical Documentation, Risk Management, or Supplier Controls to name a few. No matter where you are in the range of having new-to-the-market medical devices or long-established legacy devices, you could find yourself in the situation of needing to remediate.  >> Click Here to Read a Case Study: Revamping Supplier Quality Remediation So, remediation is needed - now what? The key to successful remediation is to strategically plan your organization’s efforts. Whether remediation is conducted for proactive or reactive reasons, the tasks to address these regulatory compliance issues can be daunting. To properly achieve an effective resolution, these efforts can require numerous resources and time, potentially disrupting new product development and current operations. Most companies do not have the capacity to plan and execute remediation activities on top of the existing day to day work. We are seeing firsthand the significant resource drain and impact throughout Regulatory, Quality, and New Product Development functions at many device companies created by remediation efforts on legacy device DHFs to achieve EU Medical Device Regulation (MDR) compliance. Not conducting thorough remediation could lead to delays in your MDR certification or, in some cases, being forced to withdraw your device from the EU market. The good news is that R&Q has experts ready to go to help you successfully achieve compliance. How R&Q can help you achieve your goals Your company may have remediation experience and a strong team, but due to tight response deadlines and capacity constraints, you are struggling to adequately support the remediation effort. On the other hand, you may be going through this type of activity for the first time. R&Q’s expertise can help to drive forward any aspect of your remediation efforts. Our adaptive team can provide: >> Click Here to Learn More About R&Q's Remediation Services  Remediation Project Management - essential planning and oversight of remediation from beginning to end. Experienced Resources - our knowledgeable and experienced team members have conducted remediation efforts across many companies and types of medical devices. R&Q can support your efforts on-site or fully remote, freeing up internal resources to continue their much-needed daily operations. Subject Matter Experts – don’t have the knowledge to address issues in-house? R&Q has the expertise to guide you. Having outside eyes to review can help to identify some glaring issues and creative solutions that may not be apparent internally. Collaboration and Ownership - R&Q has a proven track record of integration into client teams to help effectively drive remediation. This collaboration ensures the effort is not just an outside entity coming in and making changes in your company. R&Q works hand in hand with our clients throughout the process to assure business agreement and ownership. Sustainable Robust Resolutions – not just stop the leak and move along …thorough investigation and gap/risk assessments to identify root causes and precise resolutions. The R&Q team will identify the issues and root cause and then work with you to make the appropriate robust changes needed to achieve compliance and avoid reoccurrence. Long Term Assurance and Support – R&Q assists in long term compliance assurance by providing periodic Internal Audit services, as well as mock audits conducted by former FDA or Notified Body auditors. R&Q can also provide appropriate training needed for internal client employees regarding compliance, regulatory requirements, and audit preparation. Regulatory & Quality Solutions (R&Q) provides best practice strategic and tactical solutions to tackle your remediation challenges. Specializing in the United States (US) and European Union (EU) regulatory and quality environments, our team can help your medical device company successfully address deficiencies and remediation efforts related to: Notified Body non-conformity reports MDD to MDR Compliance EU Technical Documentation FDA Consent Decrees, 483 Findings, and Warning Letters Complaint / Adverse Event and Device Reporting Corrective/Preventative Action Plans Internal Audit Findings Design History Files (DHF) Risk Management Programs Supplier Quality Control The R&Q team customizes the level of support needed for your remediation efforts. Whether you need a small audit or a full team to support large scale remediation, R&Q can help every step of the way. Have questions about remediation? Contact us today and check out our remediation services page for more details on how we can help.
Read Now

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 
Read Now

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.
Read Now

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.
Read Now

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.
Read Now

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.
Read Now

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.
Read Now

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.
Read Now

EU MDR | CERs

🏅 Top 10 Questions: EU MDR and CER [Upcoming Webinar]

Are you registered for our next free webinar yet? It's one you won't want to miss and it's next week!
Read Now

EU MDR | CERs | California | DeviceTalks West

Our Advanced EU MDR and CER Workshop is coming to California in December at DeviceTalks West

  Note: Presenters/Panelists listed below subject to change. R&Q is bringing our Advanced EU MDR and CER Workshop to DeviceTalks West! Join us Dec.12 for an extensive, detailed look at EU MDR and CERs through the lens of top industry experts who have successfully implemented large-scale EU MDR programs and completed 100’s of CERs. These experts have seen what works and what doesn't, and will be sharing tips, tricks, and lessons learned. What's more, if you'd only like to attend the workshop and not the entire conference, we've made that possible. Here are the registration codes: RQFULL - 50% full conference pass RQWORKSHOP - $75 for workshop only (also includes networking opportunities) At a small company and think this doesn't apply yet? This may not be on your radar, but it should be. You'll learn from the successes and failures of larger companies who are several months into the transition, and acquire the knowledge to nimbly navigate the transition efficiently. If your organization has many device changes planned, it’s crucial to get started in order to complete the transition by May 2020. Read on for a closer look at the workshop and an exclusive registration discount code for DeviceTalks Boston.
Read Now

EU MDR | CERs | DeviceTalks Boston

Not your average EU MDR and CER workshop

Note: Presenters/Panelists listed below subject to change. DeviceTalks Boston is Oct. 8-10 this year and as part of it, R&Q is helping to organize an Advanced EU MDR and CER Workshop. It's an extensive, detailed look at EU MDR and CERs through the lens of top industry experts who have successfully implemented large-scale EU MDR programs and completed 100’s of CERs. They've seen what works... and what doesn't, and will be sharing tips, tricks, and lessons learned. At a small company and think this doesn't apply yet? This may not be on your radar, but it should be. You'll learn from the successes and failures of larger companies who are several months into the transition, and acquire the knowledge to nimbly navigate the transition efficiently. If your organization has many device changes planned, it’s crucial to get started in order to complete the transition by May 2020. Read on for a closer look at the workshop and an exclusive registration discount code for DeviceTalks Boston.
Read Now

regulatory | EU MDR | CERs

🔑 Unlock the Secrets to CERs in our May Webinar

Unlock the secrets to complying with the increased requirements for CERs in May's free R&Q webinar:   CERs – Tips, Tricks, and Lessons Learned     The session will be on Tuesday, May 22 from 1:00pm - 2:00pm EST. The presentation slides, webinar recording, and Q&A will be made available to registrants - whether you can attend the live presentation or not.   Webinar details You have heard about the increased requirements for clinical evaluation with MEDDEV 2.7/1 Rev 4 and the MDR. You may be working on new templates and updating your CERs.   And now come the questions... What do these requirements really mean? Why are we doing this? How are we going to get this all done?  
Read Now

EU MDR | Technical Documentation

💼 EU MDR – Proactive Post-Market Surveillance [Upcoming Webinar]

It's time for our next free R&Q Intelligence Series webinar. The session – EU MDR – Proactive Post-Market Surveillance: The requirements and staff it will take to do it. – will be held Tuesday, April 24ᵗʰ from 1:00pm - 2:00pm EST. If you can't view the webinar live, we encourage you to register anyway, as the presentation slides, webinar recording, and Q&A will be shared with all registrants. Click below to sign up and read on for more details about the webinar. We hope you can join us!  
Read Now

Medical Devices | News | R&Q | EU MDR | R&Q Hires

Welcome, Jacob Foster: Regulatory and Quality Solutions' New Senior Principal Engineer

Jacob Foster brings 20+ years of medical device and pharmaceutical regulatory, quality, and project management experience to R&Q. He also brings an engaging personality, eager to do more for clients. Pittsburgh, PA -- Regulatory and Quality Solutions LLC (R&Q) exists to improve people’s lives and bring more safe and effective medical devices to market for medical device and combination product companies. Our results derive from a cohesive, hard-working, entrepreneurial, and supportive culture – a culture in which Jacob Foster effortlessly fits in. R&Q is truly ecstatic to announce that Jacob Foster has been named Senior Principal Engineer. An industry veteran of the global pharmaceutical and medical device industries, Foster brings extensive management, project leadership, and hands-on quality systems development experience to R&Q’s rapidly expanding operations team. His years of experience in the ever-changing regulatory environment  - including the upcoming and all-important EU MDR - strengthens R&Q's ability to expertly and efficiently serve clients. Foster has lived through uncertain times in the industry and despite the complexity of changes, has a track record of successfully navigating and deciphering them. “I met the team at R&Q about three years ago, and became “fast friends” with each and every team member I was introduced to," said Foster. "So when the opportunity arose to join R&Q, it was one of the easiest decisions I have ever had to make. The culture of R&Q and the earnest sincerity to contribute to patient safety and client success is tangible. Who would not want to be a part of that?”
Read Now

CER | Clinical Evaluation Report | EU MDR | Clinical Evidence

Preparing your CER for MDR [Upcoming Webinar]

The upcoming EU MDR requires enhanced clinical evidence to support the device whether you have Class I or Class III products. For products that have been on the market for a long time there may be limited or no clinical studies, and yet, the new European Medical Device Regulations require your organization to provide clinical evidence on all your devices. R&Q's next Intelligence Series webinar, Preparing your CER for MDR: Gathering Clinical Evidence, will be held on Tuesday, Novemer 28th from 1:00pm - 2:00pm EST.  The presentation slides, webinar recording, and Q&A will be made available to registrants. Register in seconds at the link below, and read on for full webinar details. We hope you'll join us!
Read Now

CER | EU MDR

EU MDR / CER Portfolio Planning: The Essential Requirements [Free Webinar]

What?  Please join us for September's free R&Q Intelligence Series webinar: EU MDR / CER Portfolio Planning: Know the essential EU MDR portfolio planning requirements. The session will take place Tuesday, September 26 from 1:00pm - 2:00pm EST.   Portfolio planning is a key aspect of interfacing with your notified body. The upcoming EU MDR changes are significant, potentially impacting your device classification and the need for clinical data. Considering the overall timeline – including ISO 13485:2016 (March 2019) and MDSAP (if selling in Canada; Jan. 2019) – it will be difficult to get on notified bodies’ schedules. The time to plan is now.
Read Now

Regulatory Affairs | EU MDR

EU MDR: Your Questions, Our Answers

On May 5, 2017 the EU MDR (Medical Device Regulation) was published in the EU Official Journal. This date starts the three-year mandatory transition period where the MDR will replace the MDD (Medical Device Directive). The expanded scope of the MDR combined with the time frames for compliance is compelling medical device companies to focus significant attention on transition strategies and will require substantial hands-on work. R&Q recently presented the webinar, EU MDR: Assessing the Impact and Next Steps. During the session we answered several of your questions, a sample of which are below. To see all of the questions and answers from the session, along with the slides and recording, check out the on-demand webinar.
Read Now

IVDR | EU MDR

RESOURCE: The MDR and IVDR Have Been Published! See Our Table of Key Dates

Publication in the Official Journal of the European Journal on May 5, 2017 means the regulations will enter into force on May 26, 2017, twenty days after publication. We will have a three-year transition period for the MDR and a five-year transition period for the IVDR. Products can be issued a certificate under the MDD with a full five-year expiry for the first two years of the transition period but should comply with all other aspects of the MDR in May, 2020. Since most IVD products are currently on the market as a self-certified they will require certificates by the end of the five-year transition period where most products now require Notified Body involvement.  
Read Now

EU MDR

EU MDR and Clinical Evidence: What You Need to Know

THE SKINNY: The Council of the European Union adopted the proposed new European Medical Device Regulation (EU MDR) in March 2017 and passed by Parliament in April 2017. It is expected to be published in the Official Journal of the European Union in the upcoming weeks, making the application date mid-2020. The EU MDR will replace the Medical Device Directive (Council Directive 93/42/EEC) and the Active Implantable Medical Device Directive (Council Directive 90/385/EEC). Among the vast changes occurring with this transition from directive to regulation are the new requirements surrounding clinical evidence. If you found the clinical portion of your technical documentation to be challenging in the past, you need to prepare for some additional hurdles.   ~ Note: This post is just a taste of the detail we'll explore during our R&Q Intelligence Series webinar on EU MDR April 25th at 1:00pm EST. All registrants will have access to the slides and recording from the session.  
Read Now

webinar | EU | Europe | European Union | EU MDR

EU MDR: Assessing the Impact and Next Steps [Webinar]

Part of your month, every month: R&Q Intelligence Series webinars are held on the fourth Tuesday of every month. These free webinars from some of the medical device industry's leading-most experts are designed for reporting on and analyzing the top industry trends and topics in the medical device space, each providing key and actionable takeaways for attendees. Slides and recordings will be made available to all registrants. Next up: May 23rd, where discuss MEDDEV 2.7.1 & CERs.
Read Now
1

We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.

Book a Consultation

GLOBAL BOTTOM CTA INSTRUCTIONS:

To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!