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  • Regulatory NewsRegulatory News

    MDR/IVDR Guidance: MDCG Explains What’s Coming

    The European Commission’s Medical Device Coordination Group (MDCG) on Friday unveiled its plans for releasing almost 50 future guidance documents related to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), with the bulk of the new guidance coming on the oversight of notified bodies (NBs) and clinical investigations and evaluation (CIE). The list also notes that much of the guidance will be endorsed by the MDCG later this year or in 202...
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    EC Publishes New Guidelines on Good Clinical Practices for ATMPs

    Thanks to a 2007 regulation on advanced therapy medicinal products (ATMPs), the European Commission (EC) on Wednesday released new guidelines on the good clinical practice (GCP) requirements for these complex and innovative products that can include gene and cell therapies. The 15-page guidelines discuss clinical trial design, non-clinical studies, quality of the investigational ATMPs, the safe conduct of the clinical trial, upstream interventions on subjects and admini...
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    Classifying Software Under MDR, IVDR: New Guidance From MDCG

    The European Commission’s Medical Device Coordination Group (MDCG) on Friday released guidance to help medical software manufacturers understand the criteria for the qualification of software under the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The guidance discusses certain types of software that would be classified under MDR or IVDR, such as software that can directly control a (hardware) medical device (e.g. radiotherapy treatm...
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    MDR Guidance Addresses Transitional Provisions

    The European Commission’s Medical Device Coordination Group (MDCG) on Friday released guidance to further explain Article 120(2) of the EU Medical Devices Regulation (MDR), which says that certificates issued in accordance with the previous device directives will remain valid until 27 May 2024. The MDCG notes that Article 120(3) of MDR establishes that the notified body that issued a device certificate continues to be responsible for the appropriate device surveillance ...
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    IMDRF Offers New Guidance on Cybersecurity

    In its first guidance document to deal exclusively with the cybersecurity of medical devices, the International Medical Device Regulators Forum (IMDRF) this week released new general principles and best practices to facilitate better international regulatory convergence on the topic. The 45-page guidance document, developed by a working group led by officials from the US Food and Drug Administration (FDA) and Health Canada, includes both pre-market and post-market cyber...
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    EC Offers MDR Guidance on New Safety and Clinical Performance Summary

    The European Commission’s Medical Device Coordination Group recently released guidance to help manufacturers create a new summary of safety and clinical performance (SSCP), as required by the EU’s Medical Devices Regulation (MDR) for implantable devices and for class III devices that are not custom-made or investigational. The SSCP, which will be validated by a notified body (NB) and made publicly available via the EU database on devices known as Eudamed, is expected to...
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    TÜV Rheinland Becomes 5th Notified Body Designated Under MDR

    The European Commission on Thursday announced that Germany’s TÜV Rheinland is the fifth notified body (NB) to be designated under the EU’s Medical Devices Regulation (MDR). A TÜV Rheinland spokesperson told Focus that beginning tomorrow, "we are accepting applications under MDR. We have also applied under IVDR [in vitro diagnostic regulation]. Our JAT [joint assessment team] audit under IVDR is scheduled to be during the first week of December and we expect to have ou...
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    RAPS Honors Winners of Founder’s Award, Community Leadership Award and New Patient-Centered Health Award

    RAPS today recognized five distinguished individuals and one leading advocacy organization for contributions to the regulatory profession and to promoting public health.   “The Founder’s Award is RAPS’ highest honor,” said RAPS Executive Director Paul Brooks. “It recognizes exemplary professionals who have had a substantial and sustained impact over the course of their careers, shaping regulatory policy and practice, and advancing the regulatory profession.”   The ...
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    EC Explains New MDR, IVDR Rules for Designating Expert Device Panels

    The European Commission (EC) on Wednesday published an implementing decision on how new medical device expert panels will be designated under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The panels will provide scientific, technical and clinical assistance to the EC, the Medical Device Coordination Group (MDCG), member states, notified bodies and device manufacturers. In particular, the implementing decision notes that notified bodies ...
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    EC Names New Health Commissioner as Pharmaceutical and Device Units Shift to DG Sante

    European Commission President-elect Ursula von der Leyen unveiled her new team of commissioners-designate this week, including the addition of Stella Kyriakides, a medical psychologist from Cyprus, to lead the health portfolio. Moving forward, Kyriakides’s leadership will be crucial in the implementation of the EU Medical Devices Regulation (MDR), which has a looming implementation deadline next May, and the In Vitro Diagnostics Regulation (IVDR), which has an implement...
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    EC Adds IMQ as Fourth Notified Body Designated Under MDR

    The European Commission (EC) on Tuesday added Milan, Italy-based IMQ Istituto to its list of notified bodies (NBs) designated under the new Medical Devices Regulation (MDR). The announcement does not come as a surprise, as Italy’s Ministry of Health announced in late July that IMQ met the requirements of the regulation. The EC had also previously indicated in its rolling plan,  updated last Monday , that four NBs have been designated. The other three NBs to be de...
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    APEC Members See Increased Regulatory Convergence

    Countries involved in the Asia-Pacific Economic Cooperation (APEC) are better aligning their regulatory schemes related to drugs and medical devices, according to a new survey unveiled Monday at an APEC meeting in Chile. The survey shows how between 2008 and 2019, APEC countries are seeing modest increases in: Sharing information (from 16 APEC economies to 19 economies) Establishing confidentiality commitments (from 12 economies to 15) Sharing good manufacturing pr...