8 April 2026
From the regulatory newsfeeds of the Nordic medical product agencies, Arex Advisor has rounded up a selection of highlights from the past month.
SWEDEN
Companies urged to register under NIS2 cybersecurity requirements
4 March 2026
Organisations covered by the Cybersecurity Act (NIS2) must register, regardless of sector, following the opening of the notification process in February. The Swedish Medical Products Agency, which supervises medicines and medical devices manufacturers as well as pharmaceutical R&D, is urging affected companies to ensure compliance. Read more (in Swedish)
SWEDEN
Environmental role in antibiotic resistance may be underestimated
23 March 2026
Antibiotic resistance remains a major global public health threat, and a new report from the Swedish Medical Products Agency highlights that environmental factors may play a more significant role in its development and spread than previously recognised. The findings are intended to support Sweden’s strategy against antimicrobial resistance (AMR) for 2026–2035. Read more (in Swedish)
SWEDEN
Common data structure to strengthen clinical trials in Sweden
23 March 2026
The Swedish government has allocated SEK 3 million to seven regions, together with industry bodies Lif and SwedenBIO, to develop a shared national information structure as part of the Swetrial initiative. The effort aims to improve data quality, enhance comparability, and support more reliable planning and follow-up of clinical trials. Read more (in Swedish)
DENMARK
Denmark issues guidance on Investigator’s Brochure for ATMP trials
6 March 2026
The Danish Medicines Agency has published new guidance outlining the required content of the Investigator’s Brochure for clinical trials involving advanced therapy medicinal products. The document supports sponsors in preparing robust and compliant trial documentation, tailored to the specific complexities of ATMP development. Read more
FINLAND
Fimea stresses compliance when handing over medical devices to patients
9 March 2026
Finnish Medicines Agency (Fimea) is urging professional users to pay closer attention to regulatory requirements when handing medical devices over to patients. The obligations, set out in Chapter 4 of Finland’s Medical Devices Act (719/2021), reinforce responsibilities for ensuring safe use and proper instruction outside healthcare settings. Read more
How do these changes affect you?
Our experienced specialists are ready to help you navigate the regulatory landscape!