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RQM+ Medical Device and In Vitro Diagnostic Blog
Topic: IVDR
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Structured Dialogue: A Key to Efficient Regulatory Compliance in the EU
on 21 October 2024 | By Jaishankar Kutty, Ph.D., RQM+ Vice President, Global Regulatory Affairs
As the regulatory landscape for medical devices and in vitro diagnostics (IVDs) in the European Union becomes more stringent, the need for transparent and efficient communication between manufacturers and notified bodies has never been more critical. The structured dialogue...
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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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Review of RQM+ Findings in Mock Audits and Notified Body Submissions
on 2 November 2022 | By Rem Siekmann, RQM+, Ronald Sills, RQM+
The transition to EU MDR and EU IVDR has come with a steep learning curve for all in the industry, including both manufacturers and notified bodies. With hundreds of MDR and IVDR technical files under our belts, we have learned a lot about the most common findings — and how to...
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Impact of a High-Quality IVDR Notified Body Application
on 26 July 2022 | By Heike Moehlig-Zuttermeister, PhD, RQM+ VP Intelligence and Innovation, IVD
The transition from IVDD (98/79/EC) to IVDR (EU 2017/746) has been overwhelming for many manufacturers, especially those that have never worked with a notified body because they were previously able to self-certify under the IVDD. Many are now realizing that the IVDR notified...
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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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IVDR State of the Art (SOTA)
on 27 April 2022 | By RQM+ Subject Matter Experts
State of the art (SOTA) is a key piece of the IVDR puzzle. Like many of the other required elements, it touches multiple sections of your technical documentation and must be consistently addressed throughout.
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Risk Management Challenges with IVDR Compliance - This May Be Your Biggest Obstacle
on 13 April 2022 | By Amie Smirthwaite BEng, PhD, FRAPS, RQM+ Senior Vice President, Intelligence & Innovation
IVD manufacturers have had to make significant improvements to their risk files since the days of IVDD. What was once the reality—static and often incomplete files that hardly changed after being placed on the market—is no longer acceptable. However, despite making major headway...
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What You Need to Know About Significant Changes Under IVDR
on 23 March 2022 | By RQM+ Subject Matter Experts
Until recently, many IVD manufacturers were able to make changes to the design or intended use of their devices with minimal consequences under IVDD (98/79/EC). With the transition to IVDR and the date of application just around the corner, that time window is quickly closing....
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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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Just Released: MDCG Guidance 2022-3 Verification of Manufactured Class D IVDs by Notified Bodies
on 17 February 2022 | By Heike Moehlig-Zuttermeister, PhD, RQM+ VP Intelligence and Innovation, IVD
The MDCG guidance 2022-3 Verification of manufactured class D IVDs by notified bodies was issued earlier this week on the 15th of February 2022. This guidance is important for manufacturers because it provides a detailed specification of the requirements for the testing plan and...
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Dr. Heike Moehlig-Zuttermeister Joins RQM+ as IVD Vice President Intelligence and Innovation
on 9 February 2022 | By RQM+ Subject Matter Experts
RQM+ is excited to announce the addition of Dr. Heike Moehlig-Zuttermeister as IVD Vice President Intelligence and Innovation. Heike joins us after nearly eight years at BSI, where she held leadership roles within the IVD team.
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MDR and IVDR Mock Technical Assessments and Design Examinations
on 10 January 2022 | By Amie Smirthwaite BEng, PhD, FRAPS, RQM+ Senior Vice President, Intelligence & Innovation
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...
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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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Facts & FAQs: European Commission Proposal for Amendment of the IVDR (EU) 2017/746
on 19 October 2021 | By RQM+ Subject Matter Experts
Background The COVID-19 pandemic has led to unprecedented challenges for the In Vitro Diagnostic Regulation (IVDR) implementation impacting both manufacturers and key European Union (EU) infrastructure. On one hand, manufacturers were faced with staff shortages impacting their...
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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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EU Update: SARS-CoV-2 In Vitro Diagnostic Medical Device Performance Evaluation MDCG Guidance Published
on 13 September 2021 | By Ashley (Ash) Clark, MS, RAC, RQM+
A new guidance document (MDCG 2020-21) has been published on the 3rd of August by the Medical Device Coordination Group (MDCG) pertaining to performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices. This document provides extensive details on what is expected for...
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![[Webinar] Strategies for Overcoming the Biggest Challenges in Achieving IVDR Compliance](https://www.rqmplus.com/hs-fs/hubfs/Blog_Images/RQMPlus%20Webinar.jpg?length=450&name=RQMPlus%20Webinar.jpg)
[Webinar] Strategies for Overcoming the Biggest Challenges in Achieving IVDR Compliance
on 21 June 2021 | By RQM+ Subject Matter Experts
The latest addition to our webinar series covers the biggest challenges in IVDR compliance. With hundreds of MDR submissions under our belts and a number of clients who have already received findings from their IVDR applications, we have learned a lot about the regulation, the...
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Join the RQM+ IVDR Session During RAPS Euro Convergence 2021
on 5 May 2021 | By Deven Hennon, RQM+
We are excited to host a panel discussion during next week's virtual RAPS Euro Convergence 2021! Join our expert panel for our session on IVDR Implementation Best Practices and Challenges. See the schedule here and find more details on our session below.
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How to Obtain CE Marking Under the IVDR
on 28 April 2021 | By Nancy Morrison, RQM+
CE marking is the system used in the EU to indicate that products meet the region’s safety, health, and environmental protection requirements. Products labeled with the CE marking can be freely traded in the European Economic Area without restrictions.
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MDCG 2020-16 Classification Guidance for IVDs
on 16 February 2021 | By Ashley (Ash) Clark, MS, RAC, RQM+
RQM+ experts summarize the MDCG guidance from November 2020, Guidance on Classification Rules for the in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746, to aid IVD industry stakeholders in understanding, planning, and executing compliance to the IVDR by May...
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RESOURCE: The MDR and IVDR Have Been Published! See Our Table of Key Dates
on 8 May 2017 | By Nancy Morrison, RQM+
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...
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R&Q's Can't-Miss Education Event of the Year: An Afternoon Training Workshop at BIOMEDevice in Boston, April 13th
on 8 March 2016 | By Stephen Biernacki
Those in the northeast, get ready! Not only will R&Q be exhibiting at this year's BIOMEDevice show (booth 640) and sponsoring MassMEDIC's Annual Conference, but we'll be presenting an afternoon training workshop (three separate sessions) free to attendees of the BIOMEDevice show...
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