All EU MDR articles
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CommentaryMedical Device Regulation 2.0: Why stakeholder disagreement is bad for all
Proposals for MDR 2.0, published in December 2025, have exposed deep divisions across the EU medical devices community. This thought leadership article argues that, without genuine stakeholder consensus and structural reform, history risks repeating itself, with serious consequences for patients and industry alike.
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JournalFrom design to diversity: Embedding women’s health into medical device innovation and regulation
This article analyses how to integrate women’s health considerations to ensure inclusivity throughout the medical device development lifecycle.
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JournalOptimal materials selection in medical device development – a proactive biocompatibility approach
Regulatory Rapporteur October 2023 | Volume 20 | No.9 Introduction Biocompatibility evaluation of medical devices is a complex task related to various factors that include mainly chemical nature and physical properties of the material, the ...
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Meeting ReportMD4: Challenges and opportunities for
small companies and start-upsWhen developing novel products, small companies and start-ups must understand the regulatory pathways to market. NBs are providing support to industry in its transition to the EU Medical Device Regulation, but NBs are in high demand.