The AI Act | An updated overview
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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The Data Act’s relevance in 2026
In 2024, the regulatory environment in the EU regarding data became more complex, as three horizontal digital EU Regulations and…
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MedTech news roundup January 2026
Welcome back – and Happy New Year from our Congenius Knowledge Team! Our MedTech roundup for January 2026 kicks off…
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Sustainability in plastics manufacturing for medical devices
Sustainability remains one of the most complex challenges facing the MedTech industry. It’s a broad, often polarising topic, and many…
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2025 – that’s a wrap!
It’s been an exciting and rewarding year at Congenius. As we navigated 2025, our team achieved a number of meaningful…
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EU proposed MDR & IVDR update | What’s in the proposal?
On 16 December 2025, the European Commission published a proposal to amend the EU regulatory framework for medical devices and…
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Charity beneficiary 2025 | Insulin for Ukraine
In Switzerland, insulin is readily available. In Ukraine, this hasn’t been the case since 24 February 2022. So, this year,…
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ISO 10993-1:2025 | What’s new in the revised standard?
Back in June, our Senior Operations Consultant and Biocompatibility Specialist Dr. Silvio Peng shared five important updates from the draft ISO…
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