From the regulatory newsfeeds of the Nordic medical product agencies, Arex Advisor has selected the most important regulatory updates from the past month.
SWEDEN
Updated AI guidance for Swedish healthcare published
8 April 2026
The Swedish MPA has released an updated version of its AI guidance for healthcare, with new content focusing on considerations and risks linked to generative AI technologies. The update also clarifies how the AI Act interacts with existing medical device legislation, supporting compliance and safe implementation. Read more (in Swedish)
SWEDEN
New action plan under national medicines strategy
20 April 2026
Sweden has published its 2026 action plan to improve the use of medicines, introducing four new activities, including a national initiative to reduce medicine waste. Developed by the Centre for Better Use of Medicines (CBL) with 20 authorities and organisations, the plan supports more efficient and sustainable use of medicines. Read more (in Swedish)
SWEDEN
Updated guidance to strengthen children’s medicines use
21 April 2026
The Swedish MPA has updated its national guidance on medicines management for children and adolescents, covering the full process from prescribing and preparation to administration, follow-up and patient safety. The update aims to support healthcare professionals with clearer, up-to-date recommendations across the treatment pathway. Read more (in Swedish)
SWEDEN
EU biotech proposal raises patient safety concerns
28 April 2026
The Swedish MPA supports the European Commission’s ambition to strengthen biotechnology and clinical research but warns that parts of the proposal could risk lowering trial quality and ultimately affect patient safety. The Agency highlights the need to safeguard robust standards as the framework develops. Read more (in Swedish)
FINLAND
Fimea releases template to support medical device clinical investigations
8 April 2026
FIMEA has published a clinical investigation plan (CIP) template to support studies involving medical devices. The template helps investigators ensure compliance with both the EU Medical Devices Regulation and national requirements, promoting more consistent and robust clinical investigation planning. Read more
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