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post market surveillance | MDR | IVDR | PSUR periodic safety update report

Overcoming the Most Common Periodic Safety Update Report (PSUR) and Post-Market Surveillance (PMS) Report Challenges

— coauthored 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 no official guidance, many manufacturers are struggling with meeting the new regulatory requirements.
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MDR | regulatory | IVDR

How Your Medical Director Can Help You Scope SOTA Properly: A Physician's Perspective

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 devices or those that have been on the market for a long time, physicians can help manufacturers overcome many of these challenges.
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IVDR

IVDR State of the Art (SOTA)

— coauthored by Heike Moehlig-Zuttermeister, PhD, RQM+ VP Intelligence and Innovation - IVD and Carlos Galamba, RQM+ VP Intelligence & Innovation - IVD  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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IVDR

Risk Management Challenges with IVDR Compliance - This May Be Your Biggest Obstacle

Co-authored by Amie Smirthwaite BEng, PhD, RQM+ Senior VP, 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 in recent years, risk management is among the top issues IVD manufacturers are facing when it comes to IVDR compliance.
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EU | IVDR

What You Need to Know About Significant Changes Under IVDR

Co-authored by Carlos Galamba, RQM+ Vice President, IVD Intelligence and Innovation 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. As of 26 May 2022, IVD manufacturers will no longer be able to make changes to the intended purpose or design of a device under IVDD, and all classes of IVDs will be subject to IVDR regulations.
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MDR | IVDR

Europe: 2021 Year-End Review & Looking Ahead to 2022

Co-authored by Carlos Galamba, RQM+ Vice President, IVD Intelligence and Innovation and Nancy Morrison, RQM+ Executive Director, Regulatory & Consulting Services 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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IVD | IVDR

Just Released: MDCG Guidance 2022-3 Verification of Manufactured Class D IVDs by Notified Bodies

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 agreements for batch verification that must be in place between manufacturers, Notified Bodies (NBs) and EU Reference Laboratories (EURLs) to maintain a Class D product on the EU market. Without a successful batch verification process a Class D products is not permitted to be placed on the EU market.
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team members | IVDR

Dr. Heike Moehlig-Zuttermeister Joins RQM+ as IVD Vice President Intelligence and Innovation

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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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. 
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MDR | IVDR | SSCP Requirements | Safety and Performance (SSP)

Overcoming Challenges and Streamlining Your SSCPs and SSPs

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 finding it challenging to produce these reports because they are completely new to everybody. 
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IVD | IVDR

Facts & FAQs: European Commission Proposal for Amendment of the IVDR (EU) 2017/746

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 transition efforts and have largely shifted their focus towards the development of COVID-19 assays to fight the pandemic. At the same time, key infrastructure such as Notified Body (NB) designation, EU Reference Labs, and EUDAMED has experienced significant delays - only six NBs are designated to the IVDR, and some are at capacity already and will not take new clients. This scenario threatened significant disruption to the supply chain – the majority of IVDs under the current IVD Directive will require NB assessment under the regulation and failure to secure an assessment by May 2022 would lead to previously self-declared products coming off the market in the next seven months. Only 5% of the IVDs needing a Notified Body certificate by May 2022 have actually been granted one under this timeline. With 70% of every clinical decision being based on diagnostics, several stakeholders including NBs, healthcare professionals and patient groups expressed their concerns about a potential collapse of the healthcare system and called for urgent action. This resulted in a proposal from the European Commission on 14 Oct 2021 to review transitional provisions in the IVDR and establish a progressive roll-out. In this blog, Carlos Galamba, RQM+ IVD Director, provides the key points to be aware of in the European Commission proposal and answers the most commonly asked questions we received so far. Carlos was a leader in IVDR implementation in his role at BSI through September 2021, where he supported and led IVDR Notified Body designations, was responsible for the development of clinical procedures, technical guidance for BSI reviewers, and consulted on MDCG draft guidance prior to publication including, for example, IVD batch verification, summary of safety and performance, IVD classification rules and performance evaluation for SARS-CoV-2.
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team members | IVDR

Carlos Galamba Joins RQM+ as IVD Director

RQM+ is excited to announce the addition of Carlos Galamba as IVD Director after several years working for one of the largest Notified Bodies leading a global IVD team and assisting in the IVDR transition efforts.
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MDR | IVDR

Top 10 Tips on How to Write a PMS Report and PSUR Without an Official Guidance Document

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 not shifted, leaving manufacturers struggling to understand precisely how to be compliant.
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IVD | IVDR | COVID-19

EU Update: SARS-CoV-2 In Vitro Diagnostic Medical Device Performance Evaluation MDCG Guidance Published

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 SARS-CoV2 IVDs and is envisaged to form the basis for common specification to be adopted in coming months. Even if you are not making SARS-CoV-2 assays the testing details and sample sizes outlined in the guidance provide insight on the IVDR impact to technical documentation and Performance Evaluation Reports (PERs) and provide a glimpse into the level of evidence required.
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IVDR

[Webinar] Strategies for Overcoming the Biggest Challenges in Achieving IVDR Compliance

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 guidance that surrounds it, and what notified bodies expect to see.
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IVDR

Join the RQM+ IVDR Session During RAPS Euro Convergence 2021

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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IVDR | ivdr CE marking

How to Obtain CE Marking Under the IVDR

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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IVDR

MDCG 2020-16 Classification Guidance for IVDs

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 2022. The examples in the blogpost are not intended to be exhaustive of all scenarios of applicability.
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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.  
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IVD | compliance | UDI | Boston | IVDR | BIOMEDevice | Workshops

R&Q's Can't-Miss Education Event of the Year: An Afternoon Training Workshop at BIOMEDevice in Boston, April 13th

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 on Wednesday, April 13th from 1:00 - 4:00pm. The event will cover compliance, IVDR, and UDI... and you can choose to attend whichever session(s) you like. This will be one of R&Q's premier education events of the year and we're incredibly excited about the team we'll have on hand to share their expertise and experience, moderate discussion, and field questions. Keep on reading for complete details.
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