All MDR articles
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JournalImplications of the EU’s AI Act for medical devices and in vitro diagnostic medical devices
The integration of artificial intelligence within healthcare has heralded a new era of innovation for medical devices and in vitro diagnostics. This article explores some implications of the EU’s AI Act for the existing regulatory frameworks governing MDs, specifically the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746.
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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 ReportMD5: How to maintain your medical device
on the market and fulfil ongoing obligations
in the post-launch phaseEUDAMED is an integral part of the MDR and the actors, UDI and certificate modules are now live. The full effect of EUDAMED will not be realised until it is fully functional – all actors should accelerate their preparation for EUDAMED and upload information as soon as modules go live.
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JournalSubstance-based medical devices: regulatory challenges and prospects
Substance-based medical devices comprise a diverse group of products that are regulated under the Medical Devices Regulation, which is applicable since 26 May 2021. Compared with the previous legal framework, the MDR has introduced several extensive changes to the regulatory framework for medical devices that also impact on the marketing of substance-based medical devices in the EU…
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Meeting ReportMD1: MDR implementation – is there a future for legacy devices?
The first speaker for this session was Derek Foit. He defined legacy devices per Article 120 MDR, provided examples of class I to class III devices including nanoparticles, nasal sprays as specific cases…