MedTech news roundup June 2025
Our June 2025 MedTech news covers the recent guidance from the MDCG on the interplay between the MDR/IVDR and the…
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Post-market clinical follow-up under the EU MDR
Post-market clinical follow-up (PMCF) has become significantly more rigorous under the EU MDR to ensure enhanced patient safety following a…
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MedTech news roundup April 2025
Our April 2025 MedTech news covers new harmonised standards from the EU Commission, updates from MedTech Europe on IVDR, MDR,…
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MedTech news roundup January 2025
Our MedTech news roundup for January 2025 covers the amended IvDO, MedTech Europe’s 2024 Regulatory Survey results, the latest endorsement…
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MedTech news roundup November 2024
Our MedTech news for November 2024 covers MedTech Europe’s recommendations for EU Green Deal implementation, MDCG guidance on the regulatory…
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MedTech news roundup October 2024
Our MedTech news for October 2024 covers the EU Parliament resolution on MDR revision, MDCG guidance on IVD qualification and…
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PFAS in medical devices
Per- and polyfluoroalkyl substances (PFAS) are set to be increasingly regulated in the EU. In our 5-minute guide below, our…
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Clinical evaluation under MDR | Determining adequate clinical evidence
The introduction of MDR has significantly increased the importance of clinical evaluation for medical devices. And whilst several guidelines exist…
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