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RQM+ Medical Device and In Vitro Diagnostic Blog
Topic: MDR
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Three for the Price of One: The Latest Amendments to the MDR & IVDR Have Arrived
on 24 July 2024 | By Ed Ball, CEng, MIPEM, MIMMM – Manager, Intelligence & Strategic Execution
Since their proposal in early 2024, the MedTech industry has been awaiting the formal publication of the latest round of amendments to the EU MDR 2017/745 and IVDR 2017/746. The amendments have now been formally published in the form of Regulation 2024/18601. The regulations...
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Don't Get Caught Off Guard: How to Meet the EU's 2024 MDR Deadlines
on 30 August 2023 | By Amie Smirthwaite, Ph.D., RQM+ Senior VP of Intelligence & Innovation and Jaishankar Kutty, Ph.D., RQM+ VP of Intelligence & Innovation
To begin, a cautionary statement... The MDR transition timeline extension is not automatically applied to every legacy device! The timeline extension is conditional in nature, and there are a few key requirements that must be satisfied before manufacturers can benefit from this...
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Overcoming the Most Common Periodic Safety Update Report (PSUR) and Post-Market Surveillance (PMS) Report Challenges
on 18 May 2022 | By Jan Kloiber, Senior Principal Specialist and Celeste Maksim, Chief of Staff, Clinical and Post-Market Services
May 2022 is the one-year milestone for EU MDR and the date of application for IVDR. For medical devices that have already been approved under MDR, annual periodic safety update reports (PSURs) are due for Class IIb and III devices. Since this is the first year and there is still...
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How Your Medical Director Can Help You Scope SOTA Properly: A Physician's Perspective
on 10 May 2022 | By Andrew Tarnaris, M.D. MD (Res) FRCS (NeuroSurg), RQM+ Medical Director
State of the art (SOTA) is a key element of the technical documentation required for MDR/IVDR certification. As a new requirement for devices in lower-risk classes, many manufacturers are struggling to provide SOTA context that meets notified body expectations. Whether for new...
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Using Chemical Characterization to Achieve Biological Equivalence
on 10 March 2022 | By Jaishankar Kutty, Ph.D., RQM+ Vice President, Global Regulatory Affairs
In the EU, a device is considered to be equivalent if and only if it fulfills all the requirements of technical, clinical, and biological equivalence. Of these, biological equivalence tends to be the most nuanced and can be a confusing topic for medical device...
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Europe: 2021 Year-End Review & Looking Ahead to 2022
on 21 February 2022 | By Amie Smirthwaite BEng, PhD, RQM+ Senior Vice President, Intelligence & Innovation; Nancy Morrison, RQM+ Vice President, Intelligence & Innovation
2021 was another big year in the European regulatory realm as EU MDR and IVDR implementation continued to roll out. Let’s take a look at the highlights and lessons learned that we can apply as we go into 2022.
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Software as a Medical Device
on 7 February 2022 | By Brian Hockett, RQM+ and Chad Quistad, RQM+
Advancements in technology over the past several decades have naturally led to advancements in healthcare. Software as a medical device (SaMD) is particularly poised for growth with one of the latest advancements: the Internet of Things (IoT). Because of this and other factors,...
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Best Practices and Processes for Integrating CERs and Post-Market Surveillance Under EU MDR
on 21 January 2022 | By Jonathan Gimbel, PhD, RQM+ Vice President, Technical
The EU MDR date of application has come and gone, and most manufacturers are well aware of the new requirements. However, awareness does not necessarily equal effective implementation. One of the main challenges of MDR compliance is creating a strategy that integrates the work...
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Overcoming Challenges and Streamlining Your SSCPs and SSPs
on 8 November 2021 | By RQM+ Subject Matter Experts
In case you missed it, the latest presentation in our webinar series covers the new requirements under EU MDR and IVDR: the Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and Performance (SSP), respectively. It’s no surprise that manufacturers are...
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What Are Clinical Benefits and How Do You Evaluate Them in Your CER?
on 27 October 2021 | By Jonathan Gimbel, PhD, RQM+ Vice President, Technical
The rollout of the EU MDR has created new challenges for medical device manufacturers, including those that have had devices on the market for a long time. One area of increased focus is the need to quantitatively establish the clinical benefits to patients from the device based...
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Post-Market Surveillance: A Concise Overview of Requirements
on 5 October 2021 | By Celeste Maksim, PhD, RAC, RQM+
Following the May 2021 deadline, medical device manufacturers now have an MDR-compliant post-market surveillance (PMS) system in place. However, there are still many issues and questions around this topic which need addressing.
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Top 10 Tips on How to Write a PMS Report and PSUR Without an Official Guidance Document
on 27 September 2021 | By Jan Kloiber, RQM+ Principal
Manufacturers have relied on guidance from the Medical Device Coordination Group and similar organizations to interpret many of the new regulations under EU MDR and IVDR. However, guidance has not been provided for every aspect of the regulation, and application deadlines have...
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RQM+ MDR Clinical Evaluation Roadmap: An Interview with Dr. Jai Kutty
on 9 September 2021 | By RQM+ Subject Matter Experts
The introduction of MDR caused a major transformation in the medical device industry. Manufacturers continue to grapple with all elements of compliance, but clinical evaluation presents unique challenges. RQM+ is committed to helping clients navigate these challenges with former...
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The EU MDR Date of Application Has Arrived!
on 26 May 2021 | By Nancy Morrison, RQM+
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...
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Optimizing your Technical Documentation to reduce NB review time and questions (Medical Devices and IVDs)
on 20 May 2021 | By Nancy Morrison, RQM+
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...
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Medical Device Report | Complaint Handling | Medwatch | Complaints | Fda | Medical Device | Mdr | Adverse Event | Post Market Vigilance
Complaint Handling Solutions
on 23 May 2013 | By Ryan Kasun
In my last post “Who’s watching your MedWatching”, I commented on some of the common issues manufacturers have with their MDR and complaint handling systems. It’s useful to know what people are doing wrong, but I think it is equally important to know how to solve those issues....
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Medical Device Report | Complaint Handling | Warning Letter | Medwatch | Complaints | Fda | Medical Device | Mdr | Adverse Event | Post Market Vigilance
Who’s watching your MedWatching?
on 3 May 2013 | By Ryan Kasun
Last year, FDA received almost one million adverse event reports from manufacturers1. Needless to say, the Office of Surveillance and Biometrics has been very busy, and so have manufacturers.
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