• Biospecimen SolutionsPrecision Value & HealthCareers
    P_ForMedicine_no_tag_RGBP_ForMedicine_no_tag_RGBP_ForMedicine_no_tag_RGBP_ForMedicine_no_tag_RGB
    • Clinical
      Trial Services
        • Overview
            • Oncology Clinical TrialsImage

              Oncology Clinical Trials


              Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

              • Rare & Orphan DiseaseImage

                Rare & Orphan Disease


                With experience built on 150+ orphan disease projects covering 80+ rare diseases, we know how to anticipate logistical and regulatory obstacles and craft bold solutions that drive rare disease development programs.

        • Global Clinical Trial Support –
            • North & South America –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

            • Europe –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

            • APAC –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

        • Clinical Trial Management –
            • Study Start-up & Feasibility –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

            • Project Management –
            • Patient Recruitment –
            • Personalized Clinical Trial Operations –
            • Biometrics –
            • Medical & Safety Monitoring –
            • Clinical Data Management –
            • Medical Writing –
        • Clinical Development Strategy –
            • Clinical Development Planning –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

            • Biomarker Strategies –
            • Cell & Gene Therapy Strategies –
            • CDx Regulatory and Market Access –
        • Clinical Trial Design –
            • Basket & Umbrella Trials –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

            • Biomarker Clinical Trials –
            • Master Protocol Trials –
            • Decentralized Clinical Trials
        • Biostatistics –
            • Statistical Consulting –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

            • Study Design –
            • Data Monitoring Committees –
            • CDISC Programming and Documentation –
            • eCTD Submissions –
        • Central Lab Services –
            • Clinical Specimen Kitting –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

            • Sample Processing –
            • Global Specimen Logistics and Biostorage –
            • Biospecimen Data Services –
            • Precision Lab e-Portal –
            • Virtual Sample Inventory Management –
        • Training
            • Oncology Clinical TrialsImage

              Oncology Clinical Trials


              Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

              • Rare & Orphan DiseaseImage

                Rare & Orphan Disease


                With experience built on 150+ orphan disease projects covering 80+ rare diseases, we know how to anticipate logistical and regulatory obstacles and craft bold solutions that drive rare disease development programs.

    • Lab
      Services
        • Central Lab Services –
            • Clinical Specimen Kitting –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

            • Sample Processing –
            • Global Specimen Logistics and Biostorage –
            • Biospecimen Data Services –
            • Precision Lab e-Portal –
            • Virtual Sample Inventory Management –
        • Specialty Lab Services Overview –
            • Immune MonitoringImage

              Immune Monitoring


              Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

              • Tissue & Liquid BiopsyImage

                Tissue and Liquid Biopsy


                Obtain a detailed molecular view into patient biology with a range of tissue and liquid biopsy technologies, including our proprietary ApoStream platform which can isolate and enrich circulating tumor cells for downstream analysis.

        • EU Contract Research Organization –
        • Immune Monitoring –
            • Immune Monitoring by Flow Cytometry –
              • Immune MonitoringImage

                Immune Monitoring


                Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

            • Immune Cell Phenotyping by Epiontis ID –
            • Cytokine Profiling –
            • Gene Expression Profiling –
            • ELISpot and FluoroSpot –
            • Custom Assays –
        • Flow Cytometry –
            • Immune MonitoringImage

              Immune Monitoring


              Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

              • Tissue & Liquid BiopsyImage

                Tissue and Liquid Biopsy


                Obtain a detailed molecular view into patient biology with a range of tissue and liquid biopsy technologies, including our proprietary ApoStream platform which can isolate and enrich circulating tumor cells for downstream analysis.

        • Genomics –
            • NanoString Assays –
              • Immune MonitoringImage

                Immune Monitoring


                Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

            • ddPCR –
            • qPCR –
            • NGS –
            • Fluorescence In Situ Hybridisation (FISH) / ISH –
        • Tissue & Liquid Biopsy –
            • ApoStream – CTC and Rare Cell Isolation for Liquid Biopsy
              • Immune MonitoringImage

                Immune Monitoring


                Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

            • CTC / cfDNA / Exosome Analysis –
            • Multiplex Immunofluorescence –
            • Immunohistochemistry –
            • Fluorescence In Situ Hybridisation (FISH) / ISH
            • Pathology Services –
            • NanoString Assays
        • Bioanalytical Testing –
            • Immunogenicity Testing –
              • Immune MonitoringImage

                Immune Monitoring


                Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

            • PK Assays –
            • ADA Assays –
            • MesoScale Discovery (MSD) Assays –
            • Quanterix SIMOA –
            • ELISA
        • Cytokine Analysis –
            • ELISA –
              • Immune MonitoringImage

                Immune Monitoring


                Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

            • MesoScale Discovery (MSD) Assays
            • Luminex –
            • Quanterix SIMOA
        • Preclinical Target and Biomarker Validation –
            • Cell Based Assays –
            • Target Expression – XpressWay Profiles –
            • Tissue Cross-Reactivity –
            • Fluorescence In Situ Hybridisation (FISH) / ISH –
            • Multiplex Immunofluorescence –
            • Immunohistochemistry (IHC)
        • Biospecimens
            • Immune MonitoringImage

              Immune Monitoring


              Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

              • Tissue & Liquid BiopsyImage

                Tissue and Liquid Biopsy


                Obtain a detailed molecular view into patient biology with a range of tissue and liquid biopsy technologies, including our proprietary ApoStream platform which can isolate and enrich circulating tumor cells for downstream analysis.

    • Data
      Sciences
        • Overview
            • BiostatisticsImage

              Biostatistics


              Seasoned biostatisticians and statistical programmers support every phase of your trial, from study design for small, rare disease trials to regulatory submissions, all backed by meticulous documentation.

              • Computational BiologyImage

                Computational Biology


                Domain experts from our QuartzBio team utilize integrated and harmonized data and tailored AI solutions to drive preclinical and clinical development, including patient stratification, signature development, predictive modeling of drug response, and MOA characterization.

        • Biostatistics
        • Clinical Data Management
        • Biometrics
        • QuartzBio –
            • Biomarker Data Management –
              • BiostatisticsImage

                Biostatistics


                Seasoned biostatisticians and statistical programmers support every phase of your trial, from study design for small, rare disease trials to regulatory submissions, all backed by meticulous documentation.

            • Virtual Sample Inventory Management –
    • Diagnostics
      & CDx
        • IVD and CDx Regulatory Affairs Consulting –
          • spevialty_labs_slice-300×54Image

            Specialty Lab Services


            Our comprehensive approach starts with a foundation of expertise in key biomaker discovery and analysis methods such as immune monitoring, genomics, and bioanalysis.

        • COVID-19 & Viral Panel Assays –
          • spevialty_labs_slice-300×54Image

            Specialty Lab Services


            Our comprehensive approach starts with a foundation of expertise in key biomaker discovery and analysis methods such as immune monitoring, genomics, and bioanalysis.

        • Biospecimens Solutions 
          • spevialty_labs_slice-300×54Image

            Specialty Lab Services


            Our comprehensive approach starts with a foundation of expertise in key biomaker discovery and analysis methods such as immune monitoring, genomics, and bioanalysis.

        • Diagnostic Market Access Services –
          • spevialty_labs_slice-300×54Image

            Specialty Lab Services


            Our comprehensive approach starts with a foundation of expertise in key biomaker discovery and analysis methods such as immune monitoring, genomics, and bioanalysis.

        • Companion Diagnostics
    • Therapeutic
      Areas
        • Overview
            • By Specialty Area
              • Global-clinical-trial-support-2Image

                Global Clinical Trial Support


                Sample processing labs, clinical trial sites and offices in five continents provide the clinical reach and scale to manage complex global programs.

            • Oncology and Immuno-Oncology
              • Oncology Clinical Trials
            • Rare & Orphan Disease
              • Global-clinical-trial-support-2Image

                Global Clinical Trial Support


                Sample processing labs, clinical trial sites and offices in five continents provide the clinical reach and scale to manage complex global programs.

            • Cell & Gene Therapy
              • Cell Therapy
              • Gene Therapy
              • Cell and Gene Therapy Manufacturing
            • CNS & Neuroscience
              • Global-clinical-trial-support-2Image

                Global Clinical Trial Support


                Sample processing labs, clinical trial sites and offices in five continents provide the clinical reach and scale to manage complex global programs.

            • COVID-19
            • AutoImmune & Allergy
            • Pediatric
        • By Research Phase
        • Preclinical Development –
        • Early Phase Trials (I-IIa) –
        • Late Phase Trials (IIb-III) –
    • News &
      Insights
        • Blog –
            • iStock-945738094Image

              Blog


              Industry trends and best practices from Precision experts

              • shutterstock_1033743346Image

                Resources


                A searchable hub featuring the latest Precision case studies, white papers, capabilities brochures and more.

        • Resources –
        • Thought Leadership –
        • News –
            • iStock-945738094Image

              Blog


              Industry trends and best practices from Precision experts

              • shutterstock_1033743346Image

                Resources


                A searchable hub featuring the latest Precision case studies, white papers, capabilities brochures and more.

        • Events –
            • iStock-945738094Image

              Blog


              Industry trends and best practices from Precision experts

              • shutterstock_1033743346Image

                Resources


                A searchable hub featuring the latest Precision case studies, white papers, capabilities brochures and more.

    • About
      Us
        • Our Passion –
            • Patient RecruitmentImage

              Our Passion


              What we do, why we do it and the principles that guide us every day.

              • meet-our-peopleImage

                Meet Our People


                We are devoted professionals with deep expertise in translational science, clinical trials and data sciences.

        • Meet Our People –
        • Careers
        • Regulatory Information –
            • Patient RecruitmentImage

              Our Passion


              What we do, why we do it and the principles that guide us every day.

              • meet-our-peopleImage

                Meet Our People


                We are devoted professionals with deep expertise in translational science, clinical trials and data sciences.

    • Contact
      Us
    • Home
    • IVD Manufacturers & EU IVD Regulation Changes (May 2022)
    Blog Clinical Research Insights Translational & Lab Insights
    Article

    IVD Manufacturers & EU IVD Regulation Changes (May 2022)

    Written By Jo-Ann Fabila Gonzales • March 16, 2022 • 6 min. read

    Due diligence now ensures regulatory compliance and streamlines global marketing for in vitro diagnostics manufacturers

    In May 2017, the EU published the In Vitro Diagnostic Regulation (IVDR).1 This regulation replaces the In Vitro Diagnostic Directive (IVDD)2 and will be implemented on May 26,2022. In vitro diagnostic (IVD) manufacturers must understand the full scope of changes to ensure regulatory compliance and smooth placement and maintenance of safe, effective products on the EU market. IVDR’s better harmonisation with broadly used regulations such as those of the US Food and Drug Administration (FDA) will benefit manufacturers by streamlining access to the global market.

    Updates to the IVDR are designed to enable transparency, quality, and safety in the manufacture of medical devices

    • New clinical evidence requirements are expected to affect existing quality systems, including the structure and content of technical files
    • Evolving lifecycle information for all EU products must be submitted to the new European Databank on Medical Devices
    • Manufacturers must collect more real-world data about device usage for post-market surveillance and vigilance
    • Premarket review is required for new and most existing IVDs; there will be no grandfathering of devices
    • Manufacturers must designate a representative responsible for regulatory compliance
    • A new medical device traceability system utilises unique device identifiers (UDI)
    • EU-wide coordinated procedure to authorise multicentre IVD clinical studies
    • Product labelling is to be enhanced

    While a more harmonised regulatory framework – simplified procedures within the EU and streamlined access to the global market – offers advantages, timely compliance with these significant changes to the EU IVD CE marking process may be challenging.

    New IVD classifications complicate requirements and ratchet up demand for notified bodies

    Under the new IVDR, a four-class, risk-based system replaces the old two-class approach. (See table below.) Risk is defined as the probability of occurrence of harm resulting from the IVD’s use (for example, incorrect diagnosis) and the severity of that harm. Note that certain products not previously identified under the IVDD, such as laboratory-developed tests, companion diagnostics, and standalone software products, are now included.

    Risk Class
    Manufacturer's Responsibility
    A) Laboratory devices, instruments, and specimen receptaclesDeclare conformity with the regulation, but sterile aspects must be assessed by an NB
    B) All IVDs not covered specifically in other classification rules. Also covers self-testing IVDs for pregnancy and fertility, detection of cholesterol levels, and detection of glucose, erythrocytes, leukocytes and bacteria in urine

    Provide a full quality-management system, audit with an NB, and review of at least one technical file per generic device group, unless the devices are classified as self-testing or near-patient testing, in which case the technical files of all devices must be assessed (IVDR Annex IX, chapters I and III)

    C) A diverse mix of high-risk IVDs that present a lesser risk to the wider population. Also covers most self-testing IVDs and testing for infectious diseases and cancer, companion diagnostics and genetic screeningProvide either a full quality-management system, audit with an NB, and review of at least one technical file per generic device group (IVDR Annex IX, chapters I and III) or an EU type-examination (IVDR annexes X; XI [except for Section 5])
    D) Covers general life-threatening conditions and, more specifically, transmissible agents in blood or other biological materials intended to be transplanted or re-administered to the body

    Same as for Class C, along with batch verification and reference laboratory involvement (IVDR annexes X; XI)

    Given the scope of products that require NB review under IVDR, NBs have had to be re-designated under the IVDR.

    Assessing gaps and prioritising products

    Resultant attrition and increased workload for NBs has created a bottleneck. In response, the European Commission approved an updated, gradual rollout of the new IVDR for current IVDD CE Marked devices in late 2021.3 Even so, plan thoughtfully when preparing for the new mandates, especially where you’ll need NB approval. As the IVDR deadline approaches, focus on a limited number of products to ensure timely compliance.

    Meet complex clinical evidence requirements

    The IVDR requires far more clinical evidence than the IVDD, in proportion to each device’s risk class.

    • Perform a gap analysis of the quality of existing evidence and gauge the effort needed to generate additional supporting data. If the IVD has already cleared the FDA, the necessary technical documentation data may already exist but may need restructuring. For products evaluated only for EU commercialisation, addressing and interpreting these new demands poses a challenge.

    Prioritise currently marketed IVDs for submission, especially those with robust post-market surveillance programs.

    • Surveillance data can support the clinical evidence report and help create the template for future submissions. IVD clinical evidence reports may include scientific validity, analytical performance, and clinical performance data, based on the product’s intended purpose. The intended purpose must include details on functionality and target for detection (e.g., biomarker, disorder, condition, or risk factor). As this is a living document, assay formulation and/or performance refinements, new publications about the utility of the type of device, and post-market surveillance activities must be updated throughout the product’s lifecycle to support marketing and IVD labeling.

    Update your supply chain control

    The IVDR’s new requirements on supply-chain control encompass compliance verification, vigilance, unannounced inspections, and traceability.

    • Each “actor” in the supply chain — manufacturers, authorised representatives, system and procedure pack producers, and importers — must independently verify compliance of the previous actor and implement vigilance procedures, notifying authorities of noncompliant devices, and taking corrective action. Traceability information needs to be retained for at least 5 years after the last device was placed on the market.

    Amend IVD post-market surveillance and vigilance programs

    Implement new, continuous evaluation and improvement loops to manage risk, update the public on safety and performance, and review and update the clinical evidence report continuously.

    • New processes, such as post-market performance follow-up, periodic safety update reporting, and post-market surveillance planning and reporting will require you to review relevant data on product quality and performance safety throughout the device lifecycle. Furthermore, the reporting window for serious adverse events will be 15 days, not 30.

    Get help if required

    Significant IVDR preparations are required for compliance with the new regulations.

    • However, as an IVD manufacturer, reinvented product development strategies can globalise your approach to product launches, to seek EU and US marketing approval simultaneously. Access Precision’s unmatched experience in diagnostic development to get help with the latest regulatory changes and expedite your product from bench to bedside.

    Learn more about Precision’s end-to-end diagnostics development services >

    Key takeaways

    • The IVDR mandates sweeping changes in performance evaluation and post-market activities. Preparation requires strong quality management systems for ongoing risk monitoring and safety reporting.
    • Given the shortage of NBs, increased documentation requirements, and cost associated with the IVDR, a more gradual rollout has been approved for existing IVDD CE Marked devices.
    • Although the IVDR presents challenges in the short term, its expanded clinical evidence requirements may streamline global commercialisation.
    • In good news for IVD manufacturers, IVDR helps harmonise the development processes across submissions.
    • IVDR also benefits manufacturers by mandating operational and commercial improvements that could enhance safety, quality, and innovation.

    Explore Precision's Regulatory Expertise >

    References: 

    1. Official Journal of the European Union. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directive 90/385/EEC and 93/42/EEC. http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=DE Published 5 May 2017. Accessed 13 February 2022.

    2. Official Journal of the European Union. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0746&from=DE Published 5 May 2017. Accessed 13 February 2022.

    3. European Commission. Public health: Commission proposes a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation. Brussels, 14 October 2021. https://ec.europa.eu/commission/presscorner/detail/en/IP_21_5209 Published 14 October 2021. Accessed 13 February 2022.


    • Jo-Ann Fabila Gonzales

      Jo-ann Fabia Gonzales is an experienced regulatory affair professional with more than 20 years of experience in biotechnology. Her career has a rich focus on medical devices and IVD regulatory support.

    Precision for Medicine is part of the Precision Medicine Group, an integrated team of experts that extends Precision for Medicine’s therapeutic development capabilities beyond approval and into launch strategies, marketing communication, and payer insights. As one company, the Precision Medicine Group helps pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.

    Visit the website
    Clinical Trial Services
    • Overview
    • Global Clinical Trial Support
    • Clinical Trial Management
    • Clinical Development Strategy
    • Clinical Trial Design
    • Biostatistics
    • Clinical Sample Management
    • Clinical Research Organization
    Specialty Lab Services
    • Overview
    • Immune Monitoring
    • Flow Cytometry
    • Genomics
    • Tissue & Liquid Biopsy
    • Bioanalytical Testing
    • Cytokine Analysis
    • Biospecimens
    • Sample Processing
    • Global Specimen Transport & Biostorage
    • Contract Research Organization
    • Bioanalysis
    • Neutralizing Antibody (NAb) Assays
    • PBMC Processing
    Data Sciences
    • Overview
    • Biostatistics
    • Clinical Data Management
    • Biometrics
    • QuartzBio
    • Virtual Sample Inventory Management
    Therapeutic Expertise
    • Overview
    • Preclinical Development
    • Early Phase Trials (I-IIa)
    • Late Phase Trials (IIb-III)
    • Oncology and Immuno-Oncology
    • Rare & Orphan Disease
    • Cell & Gene Therapy
    • Neurology
    • COVID-19
    • Autoimmune & Allergy
    • Pediatric
    • Companion Diagnostics
    About Us
    • Our Passion
    • Meet Our People
    • Careers
    • ESG Policy
    • Regulatory Information

    News & Insights
    • Publications
    • Case Studies
    • Thought Leadership
    • News
    • Events
    © 2023 Precision Medicine Group, LLC. All rights reserved. Privacy Policy    GDPR