MSc Biomedical Sciences · Business Unit Manager RA IVD & Representative Services
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.
Understand sponsor responsibilities in IVD clinical performance studies across IVDR, applicable FDA requirements (including IDE where relevant), and ISO 20916, including delegation, CRO roles and combined study models.
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On 15 December 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a new IVD Roadmap, setting out the planned priorities and deliverables for its IVD regulatory programme through mid-2027. This roadmap complements the existing Medical Devices Regulatory Reform Roadmap and provides insight into MHRA’s priorities for the coming years.
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On 15 December 2025, the Medical Device Coordination Group (MDCG) published MDCG 2025-9 - Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746, introducing a streamlined regulatory pathway for Breakthrough Devices (BtX) under the MDR and IVDR. The guidance establishes a formal designation process for highly novel devices with a significant positive clinical impact, enabling accelerated conformity assessment and early market access supported by robust post-market evidence generation.
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On December 12th 2025 the European Commission has released for consultation the draft Implementing Regulation (EU 2025) laying down certain uniform quality management and procedural requirements for the conformity assessment activities carried out by a notified body designated under Regulations (EU) 2017/745 and (EU) 2017/746 of the European Parliament and of the Council.
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On 16 December 2025, the European Commission published a Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, with the stated aim of simplifying and reducing regulatory burden for medical devices and in vitro diagnostic medical devices, while maintaining a high level of public health protection.
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On 27 November 2025, the Commission Decision (EU) 2025/2371 of 26 November 2025 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the European Database on Medical Devices was published in the Official Journal of the EU (OJEU), confirming that four EUDAMED modules are fully operational.
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On October 22nd Team-NB published two new Position Papers. One addresses changes to companion diagnostic devices under the IVDR, Annex IX, section 5.2 that require prior approval by a notified body while the other is a template agreement related to the transfer of MDR formal application and of appropriate surveillance of legacy devices.
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On November 10th, 2025, the EU Member States and the European Commission opened a new call for sponsors to join the pilot coordinated assessment of clinical investigations under Regulation (EU) 2017/745 (MDR) and performance studies under Regulation (EU) 2017/746 (IVDR).
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Learn the role of the UK Responsible Person (UKRP) for medical devices and IVDs, and how they ensure compliance with MHRA requirements in Great Britain.
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Learn how the Swiss Authorised Representative (CH-REP) ensures compliance with MedDO and IvDO requirements for medical devices and IVDs in Switzerland.
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Learn why an EU Authorised Representative is essential for MDR and IVDR compliance — and how QbD RepS BV helps non-EU manufacturers enter the EU market with confidence.
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Unsure whether your IVD requires a legal representative under the IVDR? Learn the difference between in-house use, performance studies, and companion diagnostics.
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Learn how to integrate IVDs into global clinical trials while meeting IVDR and CTR requirements. Practical tips, real-world cases, and QbD expertise.
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On 28 July 2025, the Commission Delegated Regulation (EU) 2025/788 amending Delegated Regulation (EU) 2023/2197 regarding its application date was adopted. The amendment defers the application of the rules on Unique Device Identifiers (UDI) for contact lenses to 9 November 2026, ensuring manufacturers have sufficient time to implement the required technical and organizational changes.
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On 7 July 2025, Commission Implementing Decision (EU) 2025/1324 was published in the Official Journal of the European Union, which amends Implementing Decision (EU) 2019/1396 to streamline certain administrative aspects related to expert panels and introduces a new expert panel in the field of medical devices.
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On 12 September 2025, a new manual on borderline classification IVDR and MDR was published. The revision includes clarifications for borderline cases, including red blood cell additive solutions containing adenine, dual action creams with menthol and capsaicin, lactose tablets for vaginal use, microabrasion dental stain removers, medical examination table covers, and mobile sterile air systems. Other examples remain unchanged. Manufacturers and regulatory teams can use the updated manual to confirm the correct qualification and classification of their products, supporting compliance decisions and avoiding potential regulatory disputes.
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The paper explains how the Master UDI-DI solution, introduced through recent Delegated Regulations, is intended to address the high level of individualisation of such devices by grouping them under a common identifier in EUDAMED. This approach is designed to ease the regulatory burden by avoiding the proliferation of identifiers for similar devices, while ensuring traceability and compliance with the MDR. MDCG 2025-7 clarifies the applicable timelines, the labelling obligations for the Master UDI-DI, the requirement to use the UDI/Device registration module of EUDAMED, and how these obligations interact in practice.
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On 3 September 2025, the Team-NB published a revised version of their position paper on Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. The revision includes updates to various sections and brings the content up-to-date. Additionally, clarification in wording and improved formatting is included.
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Annex XIV performance study applications often face delays. Discover the 5 most common causes and how to avoid them for smoother IVDR compliance.
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On 13 June 2025, the European Commission, together with EU Member States and the European Medicines Agency (EMA), launched the first phase of the COMBINE Project 1 pilot—a one-stop, coordinated assessment process for combined clinical trials of medicines and performance studies of companion in vitro diagnostic (IVD) devices.
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Last week, the Medical Device Coordination Group (MDCG) released four key guidance documents under the EU MDR and IVDR frameworks, addressing crucial aspects of performance studies, software qualification, and the interplay with the Artificial Intelligence Act.
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On May 5th, 2025, the European Commission published a new revision of the Manufacturer Incident Report (MIR) template for reporting of serious incidents under Regulation 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR). This template will become mandatory as from November 2025. The MIR requires mandatory use of incident categories and codes established by the International Medical Device Regulators Forum (IMDRF), which were also updated on March 3rd, 2025.
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IVD manufacturers must align ISO 13485 and IVDR for a compliant Quality Management System. This article explores key considerations for harmonizing these frameworks.
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On April 14th, 2025, Team-NB, the European Association of Medical Devices Notified Bodies, released a revision of their Position Paper on the European Artificial Intelligence (AI) Act in relation to Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). This Position Paper provides an overview of the Team-NB perspective on the challenges of the AI Act, with particular attention to its implementation in the certification of (in vitro diagnostic) medical devices.
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On April 14th, 2025, Team-NB, the European Association of Medical Devices Notified Bodies, released a revision of their Best Practice Guidance for submitting Technical Documentation under Regulation (EU) 2017/745 (MDR). This third revision contains several content updates, examples of common manufacturer’s pitfalls, and a significant rewrite of sections on clinical evaluation and post-market surveillance.
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On March 18th, 2025, the Medical Device Coordination Group (MDCG) released a new revision of its guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (IVDR). This fourth revision focuses on devices to detect infectious agents, particularly SARS-CoV-2.
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This Position Paper is a Team-NB consensus document describing the pre-application, application and post-application processes through which manufacturers may apply to Notified Bodies for the certification of in vitro medical devices under IVDR.
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On February 6th, 2025, the EU Member States and the European Commission announced the launch of a pilot coordinated assessment of clinical investigations under Regulation (EU) 2017/745 (MDR) and performance studies under Regulation (EU) 2017/746 (IVDR) across multiple Member States.
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On February 7th, 2025, the Medical Device Coordination Group (MDCG) released a new revision of its guidance document containing Questions and Answers on requirements relating to notified bodies under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). This fifth revision of MDCG 2019-6 contains both new and updated questions and/or answers to questions.
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Compliance with Annex XIV is essential for certain IVD performance studies under the IVDR. Learn when these requirements apply, what documentation is needed, and how to navigate the regulatory process effectively.
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Discover why usability testing is essential for compliance and safety in Near-Patient and self-testing devices under the IVDR. Learn key guidelines, study designs, and tips for successful usability evaluations.
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On 28 January 2025, the Medical Device Coordination Group (MDCG) released its first revision of two key documents related to the European Medical Device Nomenclature (EMDN). The updates streamline the process and provide greater clarity on the use of EMDN codes. The revised FAQ offers guidance on what to do if no suitable code exists and how to propose updates. By enhancing transparency and efficiency, these changes help ensure the EMDN remains accurate and aligned with industry needs.
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The IVD expert panel has issued new scientific advice on SARS-CoV-2, noting that while the virus can still cause severe illness, it no longer poses a life-threatening risk for the general European population. This may influence the classification of SARS-CoV-2 tests under Regulation (EU) 2017/746.
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On 16 December 2024, the UK enacted the PMS Statutory Instrument, adding Part 4A on post-market surveillance to the Medical Device Regulations 2002. These regulations will come into force following a 6-month transition period on 16 June 2025. The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance to assist medical device manufacturers in preparing for the new PMS Statutory Instrument. This includes the implementation of a PMS system aligned with risk classification and type of device, requiring plans, reports, and ongoing monitoring to improve patient safety and regulatory clarity.
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On December 17th, 2024, the European Medicines Agency (EMA) released a revision of 2 guidance documents on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies, designated under Regulation (EU) 2017/746 (IVDR). Both documents, Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics and Questions & Answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies were updated due to the new Regulation (EC) 2024/568 on fees and charges payable to the EMA (from 1 January 2025).
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On January 7th, 2025, the Medical Device Coordination Group (MDCG) released a new revision of its guidance document containing Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). This second revision of MDCG 2023-3 contains minor clarifications when compared to the first revision.
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On January 10th, 2025, the Medical Device Coordination Group (MDCG) released new revisions of the Preliminary Assessment Review templates and the forms to apply for designation as Notified Body under Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR), as well as the annexes of these documents.
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On July 8th, 2024, the Medical Device Coordination Group (MDCG) released its third revision on the guidance for classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (MDCG 2020-16 Revision 3).
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Discover how to define a clinical performance strategy for IVD devices under IVDR. Learn key steps from intended purpose to performance data assessment.
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Did you know that the IVDR mandates robust clinical evidence to support the validity and performance of IVD assays? In this article we'll explore the role of Clinical Performance in a smooth IVDR submission.
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On December 18, 2024, the Medical Device Coordination Group (MDCG) released a revision of the guidance on the verification of manufactured class D IVDs by notified bodies. This guidance document aims to provide clarity regarding the role and responsibilities of notified bodies with respect to samples of manufactured class D devices or batches of devices, in accordance with Regulation (EU) 2017/746 (IVDR).
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On December 17th, 2024, the Medical Device Coordination Group (MDCG) released Revision 1 of the 2019 guidance on sampling of Regulation (EU) 2017/745 (MDR) Class IIa/Class IIb and Regulation (EU) 2017/746 (IVDR) Class B/Class C devices for the assessment of the technical documentation. This revision addresses the fraction of devices within 1 sampling plan that need to be assessed, taking into account the validity of their certificate.
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On December 6th, 2024, the Medical Device Coordination Group (MDCG) released a Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices (MDCG 2024-16). This form shall be used by manufacturers, its mandated authorised representative or any other actor acting on behalf of the manufacturer, to inform Competent Authorities in the case of an interruption or discontinuation of supply of certain medical devices and certain in vitro diagnostic medical devices as described in Article 10a of the MDR/IVDR.
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On December 2nd, 2024, the Medical Device Coordination Group (MDCG) released a new guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED. MDCG 2024-15 includes a clarification on the procedure to be followed by the clinical investigation sponsor under Regulation (EU) 2017/745 (MDR) to submit the clinical investigation report and its summary to national competent authorities, and how these documents are managed and stored. In the absence of a similar guidance for device performance studies under Regulation (EU) 2017/746 (IVDR), this guidance is also relevant for IVD performance study sponsors.
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On November 26th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance on the implementation of the Master UDI-DI solution for contact lenses. Since its amendment by Commission Delegated Regulation (EU) 2023/2197 in July 2023, Regulation (EU) 2017/745 (MDR) foresees the assignment of a Master UDI-DI for contact lenses, which are highly individualised devices. MDCG 2024-14 now provides guidance for manufacturers in the implementation of Master UDI-DI rules for contact lenses as regards its structure, assignment, labelling and registration in EUDAMED.
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On November 21st, 2024, the Medical Device Coordination Group (MDCG) released a Q&A on the gradual roll-out of EUDAMED. This document provides a Q&A related to the implementation of the gradual roll-out of EUDAMED pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860.
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On November 11th, 2024, the Medical Device Coordination Group (MDCG) released its first revision (MDCG 2023-3 Rev 1) of the questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746. MDCG 2023-3 provides a clearer framework for key terms and concepts essential to implementing the vigilance requirements under EU Regulations (MDR 2017/745 and IVDR 2017/746). Aimed at competent authorities, economic operators, and other stakeholders, the document harmonizes definitions for effective regulatory compliance.
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Learn the essential requirements for conducting IVD clinical performance studies under the IVDR and ISO 20916:2024.
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On October 29th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance (MDCG 2024-13) on the regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices. In addition, the MDCG released its first revision (MDCG 2022-5 Rev 1) of the guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices.
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On October 30th, 2024, the Medical Device Coordination Group (MDCG) released a Q&A on the obligation to inform in case of interruption or discontinuation of supply. This document provides a Q&A related to Article 10a as introduced by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746.
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On October 16, 2024, the Medical Device Coordination Group (MDCG) released Revision 1 of the guidance on the 'Application of MDR requirements to "legacy devices" and to devices placed on the market prior to 26 May 2021' (MDCG 2021-25). This update includes adjustments to align the entire document with the general structure of MDCG guidance documents and to take into account Regulation (EU) 2023/607.
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On October 7th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance and templates for the assessment of Corrective and Preventive Action (CAPA) plans, intended for conformity assessment bodies, notified bodies, designating authorities, and Joint Assessment Teams involved in the implementation of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). It includes detailed sections on corrections, root cause analysis, corrective and preventive actions, and actions for verification of effectiveness.
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On October 9th, 2024, Commission Implementing Decisions (EU) 2024/2625 and (EU) 2024/2631 were published in the Official Journal of the European Union, adopting two new harmonized standards under Regulation (EU) 2017/746 (IVDR) and one under Regulation (EU) 2017/745 (MDR).
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On October 8th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance on determining which products fall under the scope of Regulation (EU) 2017/746 (IVDR) as in vitro diagnostic medical devices (MDCG 2024-11). It clarifies the qualification criteria for in vitro diagnostic medical devices (IVDs) and their accessories, based on their intended purpose as described by the manufacturer, and outlines the definitions, essential characteristics, and specific qualification topics related to IVDs, including specimen receptacles, products for general laboratory use, IVD kits, calibrators, control materials, software, and more.
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On September 25, 2024, the Medical Device Coordination Group (MDCG) released Revision 1 of the guidance on the application of transitional provisions for the certification of Class D in vitro diagnostic medical devices under Regulation (EU) 2017/746 (MDCG 2021-4). This update provides additional clarifications regarding the operational start date of the European Reference Laboratories (EURLs) on October 1, 2024.
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On December 21st, 2023, the Medical Device Coordination Group (MDCG) released the first revision on the questions and answers on Articles 13 & 14 on the requirements of importers and distributors of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (MDCG 2021-27 Revision 1).
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On July 9th, 2024, the European Commission published in the Official Journal of the European Commission (OJEU) Regulation (EU) 2024/1860 amending regulations (EU) 2017/745 or the Medical Device Regulation (MDR) and Regulation (EU) 2017/746 or the in vitro diagnostic medical device regulation (IVDR) as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply and transitional provisions for certain in vitro diagnostic medical devices.
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On July 2nd, 2024, the Medical Device Coordination Group (MDCG) released a first revision on the guidance on standardization for medical devices (MDCG 2021-05 Revision 1). This updated guidance provides comprehensive insights into the standards in the medical devices sector, aligning with EU legislation requirements such as Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).
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On June 17th, 2024, the Medical Device Coordination Group (MDCG) released a new revision of the guidance to the authorities responsible for notified bodies and joint assessment teams (JATs) when conducting assessments of conformity assessment bodies (CABs) that apply for designation of notified bodies (NB) in the field of medical devices and/or in vitro diagnostic medical devices and re-assessment of NBs (MDCG 2022-13 Revision 1). This guidance is intended for use by Designating Authorities and Joint Assessment Teams to assist them when conducting assessments of Conformity Assessment Bodies applying for designation as NB or when reassessing NB and now includes updates on the conduct of joint assessments relating to extending the scope of designations.
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On May 27th, 2024, the Medical Device Coordination Group (MDCG) released a second revision on the guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD (MDCG 2022-4 Revision 2). This second revision includes adjustments all over the document to align it to Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
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On June 25th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance on the clinical evaluation of orphan medical devices (MDCG 2024-10). This document provides guidance to manufacturers and notified bodies on the clinical evaluation pursuant to the Regulation (EU) 2017/745 on medical devices (MDR) of medical devices and accessories for medical devices that qualify as ‘orphan devices’ (OD) and medical devices and accessories for medical devices that have an orphan indication, within the meaning of this guidance.
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On June 11th, 2024, the Medical Device Coordination Group (MDCG) released a new Device Specific Vigilance guidance (MDCG 2024-1-5 - DSVG 05) for Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence.
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On May 15th, 2024, the Medical Device Coordination Group (MDCG) released 4 new documents for notified bodies. These forms will be used to document the Designating Authorities (DA) review of the Notified Bodies documentation for (re-)assessment.
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A new survey shows a sharp decline in MDR/IVDR applications and certifications, urging immediate action for compliance before 2025. Stay informed.
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New EU regulations challenge IVD manufacturers with stricter PMS and PMPF requirements. Learn why prioritizing them is crucial under IVDR.
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On April 25th, 2024, the European Parliament approved the proposal made in January 2024 by the European Commission for a Regulation amending Regulations 2017/745 MDR, and 2017/746 IVDR as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices. In the next steps, the proposal will proceed to the European Council for final endorsement before being published in the Official Journal of the European Union.
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Discover why clinical evidence is essential for IVDR compliance in IVDs and learn about the common challenges manufacturers face.
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Even with the European Commission's proposal for extending the transitional period for IVDs, manufacturers should start building compliant Technical Documentation now.
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On April 15th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance document on safety reporting in performance studies of in vitro diagnostic medical devices (IVDs) as per Article 76(2) of Regulation (EU) 2017/746 – In Vitro Diagnostic Medical Device Regulation (IVDR). This document provides guidance on reporting methods, definitions of terms, timelines, and templates for safety events in IVD studies.
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On April 17th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance document on content of the Investigator’s Brochure for clinical investigations of medical devices under Regulation (EU) 2017/745 or the medical device regulation (MDR) (MDCG 2024-5). This guidance is intended to support sponsors in developing their Investigator’s Brochure by describing in greater detail what type of information is expected in the respective IB sections, in order to preempt questions from the competent authorities during the assessment of the clinical investigation application.
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The European Commission proposes extending IVDR compliance deadlines. Discover why the extension is needed and what it means for IVD manufacturers.
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Play IVDR Transitional Extension: Why full speed ahead is still the best strategy \| QbD Group AI-generated audio 3:32 IVDR transitional extension: Why still move ahead? from QbD Group on Vimeo  Playing in picture-in-picture [](https://vimeo.com/qbdgroup?fl=pl&fe=po) IVDR transitional extension: Why still move ahead? [QbD Group](https://vimeo.com/qbdgroup?fl=pl&fe=by)
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The Medical Device Coordination Group (MDCG) released a procedure for the updates of the European Medical Device Nomenclature (EMDN). The EMDN, as established by Article 26 of Regulation (EU) 2017/745 – MDR and Article 23 of Regulation (EU) 2017/746 - IVDR, will be annually reviewed and updated based on the practical use of the EMDN and feedback from its users (MDCG 2024-02).
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The Medical Device Coordination Group (MDCG) released a Device Specific Vigilance Guidance Document (DSVG) to harmonize vigilance reporting and provide guidance for manufacturers of Specific Devices. This document outlines the way to report incidents and serious incidents, defined in Article 2(64) and (65) MDR and in Article 2(67) and (68) IVDR, in accordance with Articles 87 and 88 MDR and Articles 82 and 83 IVDR, which occurred with Specific Devices to the relevant Competent Authority (MDCG 2024-01).
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This guidance document, developed by contributions from national competent authorities, industry, and relevant stakeholders, aims to support sponsors of Clinical Investigation Plans (CIPs) in medical device studies by detailing the information needed in respective CIP sections. It addresses the legal requirements from various regulations for combined studies of medical devices and pharmaceuticals, ensuring compliance with MDR requirements.
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New harmonized standards for MDR and IVDR provide essential technical requirements to support compliance for medical devices and IVDs in the EU market.
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EU Commission proposes IVDR & MDR amendments: Eudamed rollout, supply interruption reporting, extended transitional provisions for certain IVDR devices.
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The Council of the European Union officially endorsed without any changes the proposal to amend IVDR and MDR, introducing an extension of the transitional provisions for certain in vitro diagnostic medical devices and a gradual roll-out of Eudamed to ensure device availability and patient safety.
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EMA released Q&A on biomarker-guided meds, excluding clinical trial approval and CDx conformity. Offers guidance for marketing authorization data generation.
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EU Commission publishes language requirement tables for MDR and IVDR to help medical device manufacturers meet language compliance across EU Member States.
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