• Regulatory NewsRegulatory News

    Euro Convergence Day 2: How to build a regulatory strategy, tackling IVDR and more

    The second day of RAPS Euro Convergence 2021 will bring attendees updates on challenges ahead for implementing the new In Vitro Diagnostic Regulations (IVDR), optimized strategies for drug development, why Europe may be lagging in medical technology and more.   Medical device strategies that span the Atlantic On 11 May, Chrisophe Amiel of Voisin Consulting Life Sciences (VCLS) will address how firms can build a strategy for medical devices and electronic health tec...
  • Regulatory NewsRegulatory News

    Euro Convergence: Regulators and industry seek ‘sparks’ of European change

    The opening plenary of RAPS Euro Convergence 2021 saw regulators, competent authorities, and industry representatives highlighting pressing regulatory issues for in vitro diagnostics and combination products, among other topics.   The plenary kicked off with regulators presenting “sparks,” or hot button topics intended to trigger discussion; an industry panel was then given the chance to respond to proposals from the panel of regulators and notified body representati...
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    MDR/IVDR: Commission adopts new standardization request

    The European Commission this week adopted a new standardization request for harmonized European standards in support of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) after its initial standardization request was rejected last year.   In a commission implementing decision dated 14 April 2021, the Commission calls on the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENE...
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    MDR/IVDR: Commission updates on implementation, notified body designation

    The European Commission last week updated its rolling plan detailing the actions and initiatives necessary to ensure the smooth rollout of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).   With MDR’s date of application just weeks away, Finland’s Eurofins Expert Services Oy on Wednesday became the 20 th notified body designated under the regulation. Just four notified bodies have been designated under IVDR.   Based on the pipeli...
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    MDCG offers guidance on Class D tests during IVDR transition

    The European Commission’s Medical Device Coordination Group (MDCG) on Friday issued guidance on how certifications of the highest risk in vitro diagnostics (IVDs) under the In Vitro Diagnostic Regulation (IVDR) will be handled during the transition period that runs until 26 May 2022.   Under IVDR, diagnostics are divided into four classes, A, B, C and D, from lowest- to highest-risk, based on their intended purpose and their inherent risks, with certain requirement...
  • Feature ArticlesFeature Articles

    February's Regulatory Focus: Global and regional harmonization and alignment

    Feature articles during February included a range of topics focused on harmonization and alignment across global and regional regulatory entities, including electronic submissions through the European Medicines Agency (EMA), tools for updating the EU In Vitro Diagnostic Regulation (EU IVDR) template, China’s new PAC regulation, Project Orbis and improving patients access to new therapies, as well as a report on medtech companies’ preparation for EU Medical Device Regulatio...
  • Feature ArticlesFeature Articles

    Tools for updating the IVDR template for demonstrating scientific validity

    In vitro diagnostic (IVD) testing has risen to meet the new EU regulations in the face of the significant pressures to achieve and perform adequately during the prevailing global adversity. That means existing templates must be structured to meet the new requirements of the In Vitro Diagnostic Regulation (IVDR) and demonstrate compliance with the general safety and performance requirements in Annex I of Regulation (EU) 2017/746. 1   The World Health Organization’s Glo...
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    European Commission appoints members to MDR/IVDR expert panels

    The European Commission this week released the names of members appointed to its 12 expert panels on medical devices and in vitro diagnostics (IVDs).   The expert panels, established under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), will provide scientific, technical and clinical input to the Commission, its Medical Device Coordination Group (MDCG), member states, notified bodies and manufacturers. In particular, notified bodies ...
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    EC names fifth notified body for IVDR

    The European Commission (EC) has announced designation of a fifth notified body for the European Union In Vitro Diagnostic Regulation (IVDR). TÜV Rheinland, the new notified body, was also designated a notified body for the upcoming Medical Device Regulation (MDR) in 2019. (Related: TÜV Rheinland becomes 5th notified body designated under MDR , Regulatory Focus 26 September 2019)   Implementation of MDR has been delayed by a year to May 2021 because of concerns abou...
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    Eudamed launched with actor registration module live

    The European Commission’s Eudamed database, a critical component of the EU’s Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), launched on Tuesday with the actor registration module available to member states and economic operators.   “Eudamed will provide a living picture of the lifecycle of medical devices that are made available in the [EU],” the Commission writes, noting that the aim of the database is to increase transparency for medi...
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    November's Regulatory Focus: US, China, and EU: Regulatory and strategic considerations

    Feature articles during November focused on a range of topics, including a comparison of US drug regulatory pathways with those in China, as well as the application of EU and US guidelines during product development for advanced therapies. The line-up also included articles on the challenges in getting contemporaneous approval for medicines and companion diagnostics, and the importance of early planning in preparation for the transition to the EU In Vitro Diagnostic Devi...
  • Feature ArticlesFeature Articles

    Getting ready for the EU IVDR transition

    This article discusses a manufacturer’s challenges and solutions to preparing currently marketed in vitro diagnostic (IVD) devices for new requirements under the In Vitro Diagnostic Device Regulation (EU IVDR) 2017/746.   Introduction It is daunting, in the best times, to work together to develop and manufacture IVD tests and instrumentation and coordinate their readiness for regulatory review. To get functional area heads in a global company to review and summarize ...