Compliance Blog

This page will be in English since compliance documentation and bureaucracy is usually in English. For Danish content, please fill in the contact form below.




Medical Device Regulation (EU) 2017/745, Official Journal of the European Union:

Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, Official Journal of the European Union:

MDCG guidance documentation overview, European Commission:

Ongoing Guidance development within MDCG Subgroups, European Commission:

Patient Data Del 1PNG
Patient Data Del 2PNG


General Data Protection Regulation (EU) 2016/679:

The Danish Health Data Authority (Sundhedsdatastyrelsen): ”Guidance on information security in the health sector” (“Vejledning om informationssikkerhed i sundhedsvæsenet”):

Europol: ”How criminals profit from the COVID-19 pandemic”:

Contact us