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Simplifying EU Medical Device Regulations: Understanding the 2025 Proposal
The European medical device sector is a vital pillar of healthcare innovation, employing over 930,000 people and representing a market of approximately €170 billion. However, since the implementation of MDR and IVDR, manufacturers—especially SMEs—have faced increasing regulatory complexity, long certification timelines, and reduced market predictability.
In this podcast episode, we explore the 2025 EU proposal designed to address these challenges by simplifying regulatory processes while preserving patient safety.
The discussion covers:
Key shortcomings of the current MDR/IVDR framework
The…
The skinny
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