Articles for the ‘’ Category

New Legal Provision Addressing Counterfeit and Unauthorized Practices in the Medical Device Industry

Published 30 October 2025 by Dicle Doğan Gün + Partners, Turkey

The Turkish Medicines and Medical Devices Agency updated its Guidelines on Scientific Meetings and Educational Events for medical devices on 4 January 2024, introducing a notable change of imposing a fee for event applications, set at TRY 1,114.02, effective immediately. This update eliminates the need to upload a commitment letter for event notifications and aims to streamline processes and enhance transparency in industry activities. However, the decision to charge fees has sparked criticism for potentially reducing the number of notifications by imposing additional financial burdens on companies. Further, similar fees will apply to pharmaceutical companies, although guidelines for pharmaceutical products have not been updated yet.

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Food Hygiene for Fish: EU General Court Requires Scientific Basis to “Clarify” the Law

Published 09 October 2025 by Bregt Raus ALTIUS Lawyers, Belgium

Food company Mowi Poland successfully challenged the European Commission’s new hygiene rules governing ‘stiffening’—a specialised fish processing technique—on the grounds that the Commission failed to obtain mandatory scientific consultation. While the Commission defended its approach by characterising the measures as mere “clarification” of existing law and citing industry guidelines as support, the EU General Court rejected this argument in its judgment of 24 September 2025 (T-354/24). Siding with the food business operator, the Court determined that the regulation imposed substantive new obligations requiring a scientific basis and consequently annulled the contested fish stiffening rules.

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