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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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RQM+ Executive Video Briefing: IVDR New Transition Timelines

While we are happy and relieved for the IVD industry to have an extension to the IVDR transition period, we’re concerned that the announcement may result in a misperception that there is plenty of time to get the work done.
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The IVDR Performance Evaluation Report

Under the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR), every IVD must have a Performance Evaluation Report (PER). PERs consist of three pillars: scientific validity, analytical performance and clinical performance. Collating data to satisfactorily address each pillar must be a priority for IVD manufacturers. With notified bodies under severe pressure and resource limitations, they will not engage with manufacturers who cannot demonstrate that they have processes for IVDR compliance in place.
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Clinical Evidence Requirements Under IVDR

The next key regulatory milestone for manufacturers with products on the European market is the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR). A critical stage of IVDR planning is for manufacturers to assess whether they have enough clinical and performance data that meets notified body expectations.
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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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