{"id":28840,"date":"2026-04-21T08:50:34","date_gmt":"2026-04-21T06:50:34","guid":{"rendered":"https:\/\/www.chemsafe-consulting.com\/?p=28840"},"modified":"2026-04-21T08:50:34","modified_gmt":"2026-04-21T06:50:34","slug":"mdr-ivdr-revision-notified-body-opinion","status":"publish","type":"post","link":"https:\/\/www.chemsafe-consulting.com\/it\/blog\/mdr-ivdr-revision-notified-body-opinion\/","title":{"rendered":"MDR\/IVDR Revision: Team-NB concerns over MD regulation shift"},"content":{"rendered":"

The European medical device landscape is at a critical juncture. In its comprehensive position paper “Have your say<\/a>” published on April 7, 2026, Team-NB<\/strong>, also referred to as The European Association of Medical Devices Notified Bodies<\/strong>, has presented a highly sophisticated and urgent criticism of the revision of MDR and IVDR<\/strong>.<\/p>\n

Citing nearly 50 years of regulatory experts’ experience, the association warns against making efforts to improve efficiency at the expense of breaking down the preventive barriers that protect 450 million European citizens.<\/p>\n

Medical Devices Coordination Office: A New Backbone for Effective Governance<\/strong><\/h2>\n

In order to resolve the problem of “persistent structural inefficiencies” that affect the predictability and efficiency of processes at the Union level, Team-NB recommends establishing the Medical Devices Coordination Office (MDCO)<\/strong>.<\/p>\n

    \n
  • Administrative Backbone: the MDCO will provide administrative support<\/strong> for functions that currently take place in several organizations, following the AI Act\u2019s governance framework.<\/li>\n
  • Workflow: The MDCO will facilitate timeline management<\/strong> and procedures between the Notified Bodies (NBs) and the Expert Panels.<\/li>\n
  • Strict Boundaries: Crucially, the MDCO would not assume political or scientific decision-making powers<\/strong>, which will exclusively be carried out by the Commission and Member States.<\/li>\n<\/ul>\n

    Reduced Clinical Data and Article 61(10)<\/strong><\/h2>\n

    Team-NB is highly concerned with the proposed narrowing of clinical data definitions.<\/p>\n

      \n
    • Real-World Data<\/strong>: The association warns that requiring clinical experience<\/strong> to be published in “peer-reviewed scientific literature” creates an artificial threshold<\/strong>.
      \nThese risks<\/strong> may exclude important real-world evidence<\/strong> sources such as registries and case reports. Such sources are crucial in identifying safety problems in practical.<\/li>\n
    • Article 61(10)<\/strong>: The organization suggests deleting Article 61(10) entirely<\/strong>, arguing that the suggested changes could make the absence of clinical data<\/strong> the \u201cdefault\u201d for low-to-medium risk devices \u2013 Class I and II devices.<\/li>\n<\/ul>\n

      This could have disastrous repercussions if harm were to arise only through wide-scale clinical usage.<\/p>\n

      Well-Established Technologies (WET): Preventing a “Race to the Bottom”<\/strong><\/h2>\n

      One of the most disputable topics is the definition of Well-Established Technologies<\/strong> (WET).
      \nTeam-NB claims that the draft criteria<\/strong> for defining a WET device would be “open-ended”<\/strong> and would allow NBs to compete in lowering their clinical performance requirements.<\/p>\n

      The association is concerned that high-risk devices classified as WET might bypass technical documentation scrutiny, lowering oversight to levels below those seen even before the MDR was implemented.<\/p>\n

      Safety Concerns: Proactive vs. Reactive Oversight<\/strong><\/h2>\n

      The core of Team-NB’s “alarm” is the fear that the EU regulatory model is shifting from a proactive, preventive framework to a predominantly reactive one<\/strong>.<\/p>\n

        \n
      • Weakened Safeguards<\/strong>: Proposed measures like removing unannounced audits<\/strong> and reducing the frequency of Periodic Safety Update Reports (PSUR) review would significantly limit the system’s ability to identify safety issues before they cause patient harm.<\/li>\n
      • A Performance-Based Alternative<\/strong>: Instead of cutting controls across the board, Team-NB proposes an “earned relief” model<\/strong>. Under this system, manufacturers would earn reduced surveillance only after demonstrating consistent, high-quality compliance over several years.<\/li>\n<\/ul>\n

        The Threat to System Viability: SMEs and Competency<\/strong><\/h2>\n

        Finally, the document highlights a potential “crisis in terms of device delivery”<\/strong>.<\/p>\n

          \n
        • Financial Strain<\/strong>: Mandating up to 50% fee reductions for SMEs<\/strong>, who represent over 77% of NB clients, could make the Notified Body<\/strong> operating model financially unviable<\/strong>, leading to market exits and bottlenecks.<\/li>\n
        • The Competence Gap<\/strong>: Reduced regulatory activity risks an “erosion of state-of-the-art technical and clinical expertise<\/strong>” as assessors must maintain their skills through regular, in-depth conformity assessment work.<\/li>\n<\/ul>\n

          Team-NB’s message is clear and it highlight how efficiency gains must not be achieved through a uniform reduction of preventive safeguards.
          \nThe association remains committed to a framework that balances innovation and market access with a robust, risk-based oversight system that follows the device through its entire lifecycle.<\/p>\n","protected":false},"excerpt":{"rendered":"

          The European medical device landscape is at a critical juncture. In its comprehensive position paper “Have your say” published on April 7, 2026, Team-NB, also referred to as The European Association of Medical Devices Notified Bodies, has presented a highly sophisticated and urgent criticism of the revision of MDR and IVDR. Citing nearly 50 years of regulatory experts’ experience, the association warns against making efforts to improve efficiency at the expense of breaking down the preventive barriers that protect 450 million European citizens. Medical Devices Coordination Office: A New Backbone for Effective Governance In order to resolve the problem of “persistent structural inefficiencies” that affect the predictability and efficiency of processes at the Union level, Team-NB recommends establishing the Medical Devices Coordination Office (MDCO). Administrative Backbone: the MDCO will provide administrative support for functions that currently take place in several organizations, following the AI Act\u2019s governance framework. Workflow: The MDCO will facilitate timeline management and procedures between the Notified Bodies (NBs) and the Expert Panels. Strict Boundaries: Crucially, the MDCO would not assume political or scientific decision-making powers, which will exclusively be carried out by the Commission and Member States. Reduced Clinical Data and Article 61(10) Team-NB is highly concerned…<\/p>\n","protected":false},"author":2,"featured_media":28851,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[341,343],"tags":[],"class_list":["post-28840","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","category-medical-en"],"yoast_head":"\nMDR\/IVDR Revision: Team-NB concerns over MD regulation shift - ChemSafe<\/title>\n<meta name=\"description\" content=\"Team-NB warns that MDR\/IVDR revisions may weaken safety safeguards. 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