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Understanding the impact of the European Accessibility Act on Medical Devices The European Accessibility Act (Directive (EU) 2019/882)...
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The EU regulatory landscape for medical devices making use of artificial intelligence (MDAI) has become significantly more complex with...
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In 2023, the European Commission proposed a comprehensive update of the key EU pharmaceutical legislation (the "Pharma Package") to...
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A new European directive is set to significantly impact pharmaceutical companies operating within the European Union. Directive (EU)...
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On 23 December 2024, the Brussels enterprise court issued a first decision in Belgium on the so-called “SPC manufacturing waiver”. Under...
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Introduction The Royal Decree of September 13, 2023 (‘RD’), implementing Article 71bis, § 1, of the Belgian Act on Compulsory Health Care...