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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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IVD | COVID-19

EU Update: Expert Panel Views for SARS-CoV-2 Devices

The first three Performance Evaluation Consultation Procedure (PECP) views have been published for a professional SARS-CoV-2 immunoassay and a professional nucleic acid testing (NAT) assay as well as a near-patient testing NAT SARS-CoV-2 product. Considering the actual criticality of these devices, these expert panel views are a big milestone to speed up conformity assessment work conducted by notified bodies (NB) to achieve In Vitro Diagnostic Regulation (IVDR) CE marking.
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IVD

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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EU | IVD

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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EU | IVD

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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post market surveillance | medical device | IVD | ROW

Canada Regulations News for Medical Devices and IVDs

In case you missed it, the Medical Device Regulations in Canada quietly got updated in December 2020. The new regulation intends to boost post-market safety and requires manufacturers to submit a summary report, which is similar to the post-market Periodic Benefit-Risk Evaluation Report (PBRER) required for pharmaceuticals in Canada. This new requirement goes into effect on 18 Dec. 2021, which is fast approaching.
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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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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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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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MDD | EU | Europe | medicaldevices | medical device | European Union | Medical Device Directives | IVD | medicaldevice | active implantable medical device

Overview of New Medical Device Regulations in Europe

This week my inbox was flooded by notifications of a great blog post from the Emergo group, outlining the changes set to occur to the medical device regulations in Europe. Changes such as:
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