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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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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MedTech news roundup November 2025
Our November 2025 MedTech news brings you the latest on the EU Commission’s Digital Omnibus proposal, calls for EU reference…
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MedTech news roundup October 2025
Our October MedTech news roundup covers new harmonised standards from the EU Commission, the latest on swissdamed, and guidances from…
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MedTech news roundup September 2025
Our September 2025 MedTech news covers the latest regulatory updates from the EU, Switzerland, China, Canada, and Brazil. Find out…
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MedTech news roundup Summer 2025
Our summer MedTech roundup gathers the latest in industry news from July and August from regulators around the world. Find…
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How will the EU Packaging & Packaging Waste Regulation (PPWR) impact the medical device industry?
The European Union’s Packaging and Packaging Waste Regulation (PPWR) represents a cornerstone in the EU’s broader environmental and circular economy…
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