10/27/2025 11:54:53 AM Navigating the interplay of MDR and AIA: New MDCG Guidance on Medical Device AI Under the EU AI Act: EU and UK perspectives By Pieter Erasmus Maud van Haaren Hester Borgers The EU regulatory landscape for medical devices making use of artificial intelligence (MDAI) has become significantly more complex with...
5/1/2025 8:15:08 AM Latest Developments Regulation Proposal - New Genomic Techniques By Emma Stok Hester Borgers Maud van Haaren Christian Lindenthal +1 more... Show less Back in July 2023, the European Commission adopted a proposal for a regulation on plants obtained by new genomic techniques (NGTs). This...
2/26/2025 11:05:28 AM New NVWA Guidance: Handbooks on Enzymes, Flavourings, and Additives By Sabrina Lodder Maud van Haaren The Netherlands Food and Consumer Product Safety Authority (NVWA) has recently published regulatory guidance, introducing two new...
1/30/2025 9:28:21 AM New Policy for Compassionate Use Programs By Hester Borgers Maud van Haaren The Dutch Medicines Evaluation Board (MEB) has recently published a new policy for Compassionate Use Programmes (CUP).[1] To support the...
1/22/2025 11:28:54 AM EMA’s finalised reflection paper on the use of AI By Hester Borgers Maud van Haaren On 9 September 2024 the European Medicines Agency (“EMA”) issued its final reflection paper on the use of AI in the medicinal product...