All In Vitro Diagnostic Regulation (IVDR) articles
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JournalNavigating regulatory scrutiny: An analysis of requests for information in EU combined clinical trials
This article explores aspects of IVDR and how to implement these during clinical trial processes including submissions.
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Industry newsEC proposes regulation to simplify rules on medical and in vitro diagnostic devices
This industry news update shares the EC’saim to simplify medical and IVD device rules through a new proposal.
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JournalMedical device standards update: December 2025
This article is a continuation of previous updates that share medical device standards up to November 2025.
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JournalIVD7: EU reference laboratories under the IVDR – One year on
This is a report of the IVD7 session that took place at this year’s Symposium.
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JournalIVD5: Navigating conformity assessment for IVDs – Challenges and opportunities
This is a report of the HM5/MD1/IVD1 session that took place at this year’s Symposium.
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JournalIVD6: The evolution of the In Vitro Diagnostic Regulation
This is a report of the IVD6 session that took place at this year’s Symposium.
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JournalMD8: Post-market challenges for medical devices
This is a report of the MD8 session that took place at this year’s Symposium.
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JournalHM5/MD1/IVD1: Programme COMBINE – Accelerating clinical trials and medical innovation in the EU
This is a report of the HM5/MD1/IVD1 session that took place at this year’s Symposium.
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JournalEssential steps for a successful notified body application in medical devices and in vitro diagnostic products
Navigating the notified body (NB) application process is a critical step for manufacturers seeking CE certification for medical devices under the EU Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746). A well-prepared application can significantly streamline the approval process, reduce delays and ensure compliance with regulatory requirements.
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JournalIVD5: Class D IVDs
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session Leader Amanda Brown, Director of Quality and Regulatory Affairs, HP, Germany. Ashleigh Batchen, Regulatory Strategy Principal (UK), TÜV SÜD, UK. Speakers and panelists Olga Tkachenko, ...