Global regulatory requirements for medical devices differ widely in scope and interpretation. These disparities can delay product launches, elevate compliance…
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Our MedTech news for April 2026 covers updates on device classification and the expansion of WET devices under the EU…
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Our March 2026 MedTech news covers the latest on the EU / Swiss MRA, Team-NB’s thoughts on the MDR /…
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Our MedTech news for February 2026 covers further evolution for global device regulation – with new EU harmonised standards, a…
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As mentioned in last week’s article – The Data Act’s relevance in 2026, back in 2024, the EU regulatory environment…
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In 2024, the regulatory environment in the EU regarding data became more complex, as three horizontal digital EU Regulations and…
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Welcome back – and Happy New Year from our Congenius Knowledge Team! Our MedTech roundup for January 2026 kicks off…
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On 16 December 2025, the European Commission published a proposal to amend the EU regulatory framework for medical devices and…
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