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    MDCG releases long-awaited IVD classification guidance

    The European Commission’s Medical Device Coordination Group (MDCG) on Friday released its much-anticipated guidance on the classification of in vitro diagnostics (IVDs) under the In Vitro Diagnostic Regulation (IVDR).   The nearly 50-page guidance is intended to explain how IVDs should be classified to manufacturers, notified bodies and healthcare providers before they are placed on the EU market and is seen as critical to industry’s ability to accurately classify ...
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    Euro Convergence: Experts share advice, concerns and expectations for IVDR

    In a panel at RAPS’ Euro Convergence, top experts on the EU In Vitro Diagnostic Regulation (IVDR) discussed the state of the industry just 18 months before the regulation’s May 2022 date of application.   Opening the session, Gert Bos, executive director and partner at Qserve Group, laid out the stakes for IVD developers: “Yes, IVRD is different from [the Medical Device Regulation ] MDR, the pressure is much higher because there is such a big gap between the current...
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    EU regulatory tools for RA professionals

    This article provides information on the key sources of information needed for understanding and keeping up-to-date with the European regulation of healthcare products, including medical devices and in vitro medical devices (IVDs), pharmaceuticals/medicinal products, and substances of human origin (blood, tissues, cells, and organs).   Introduction Regulatory professionals who need to understand the European regulation of healthcare products will find that the main s...
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    September’s Regulatory Focus: Countdown to EU MDR and IVDR

    Feature articles during September focused on aspects of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), with articles on compliance and manufacturer obligations, and perspectives examining the current status of the regulations. The issue also included the second part of the cell and gene therapy series, and an article on regulatory tools for generic drug companies.   MDR and IVDR, close up Full implementation of MDR is slated for ne...
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    Implementing the MDR: Slowing down on the homestretch?

    With the most recent delay to 26 May 2021 as the date of application for the European Union Medical Device Regulation (MDR) 1 still fresh in our minds, 2 many wonder if it is a matter of time before we hear about the next extension. It’s a valid question, as many manufacturers still have a long way to go until they are fully compliant with the new rules and expectations. However, it does not do justice to the differences between the circumstances at the start of the firs...
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    IVDR, notified bodies, and technical documentation: The devil is in the detail

    This article discusses notified body expectations for the technical file and provides some practical tips for preparing submissions.   Introduction The “devil is in the detail” is a phrase I’m using a lot these days, and it is a feature of the In Vitro Diagnostic Device Regulation (EU IVDR) 2017/746 1 that is tripping up IVD manufacturers as they make their first submissions.   The IVDR states in Annex II that:   The technical documentation and, if applicable...
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    MDR, IVDR, and compliance: A guide for distributors

    Distributors must prepare for new incoming requirements under EU medical device and in vitro diagnostic device regulations. The importance of establishing an effective quality management system, drafting comprehensive contractual agreements and, if required, engaging notified bodies, has created much uncertainty for distributors. To fulfil these new requirements and maintain device supply chains, it is essential for distributors to act early, ensure sufficient in-house com...
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    Manufacturer obligations applying to importers, distributors, or others under MDR and IVDR

    This article discusses issues and requirements spelled out in MDR and IVDR Chapter 2 and that chapter’s Article 16, which applies to manufacturer’s obligations and responsibilities. The author addresses new quality management system (QMS) requirements for repacking and translation of labeling, and the QMS certification obligations. Also covered are cases in which manufacturer obligations apply to importers, distributors, or other persons; changing a device’s intended purpo...
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    MDR/IVDR update: Experts share what keeps them up at night

    Speaking virtually at RAPS Convergence on Monday, top European medical device and in vitro diagnostic (IVD) experts shared what keeps them up at night as the date of application for both the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) approach.   With MDR delayed to May 2021, and with Eudamed’s full rollout and the IVDR date of application seemingly on track for May 2022, regulators, industry and notified bodies have much to prepare...
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    Eudamed actor registration module set to launch in December

    In a position paper released Tuesday, the European Commission’s Medical Device Coordination Group (MDCG) confirmed that the Eudamed actor registration module will be deployed on 1 December 2020.   The module was previously expected in May, but its deployment was pushed back by the Commission just before its launch date to reflect the postponed date of application of Eudamed. At the time, the Commission said it would pursue a phased rollout of the six Eudamed modules ...
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    MDCG explains how notified bodies can use MDSAP audit reports

    In a new guidance document, the European Commission’s Medical Device Coordination Group (MDCG) details how notified bodies can reference Medical Device Single Audit Program (MDSAP) audit reports when planning surveillance audits under the Medical Devices Regulation (MDR) or In Vitro Diagnostics Regulation (IVDR).   While MDSAP audit reports cannot be used to obviate the need for annual surveillance audits required under MDR/IVDR, MDCG says the reports can be used t...
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    FDA approves pooled sampling for COVID-19 test

    Pooled sampling of COVID-19 swab specimens is now allowed under a reissued emergency use authorization (EUA) for the Quest Diagnostics SARS-CoV-2 rRT-PCR test, the US Food and Drug Administration (FDA) announced on 18 July.   Under the reissued EUA, four samples may be processed together in a batch, reducing the number of tests run and using fewer testing supplies. If the pooled sample is negative, no more testing would be required. If the pooled sample is positive, th...