Compliance Blog

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References

Medical Device Regulation (EU) 2017/745, Official Journal of the European Union: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745

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: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2020.130.01.0018.01.ENG&toc=OJ:L:2020:130:TOC

MDCG guidance documentation overview, European Commission: https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en

Ongoing Guidance development within MDCG Subgroups, European Commission: https://ec.europa.eu/docsroom/documents/38862



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References

General Data Protection Regulation (EU) 2016/679: https://eur-lex.europa.eu/eli/reg/2016/679/oj

The Danish Health Data Authority (Sundhedsdatastyrelsen): ”Guidance on information security in the health sector” (“Vejledning om informationssikkerhed i sundhedsvæsenet”): https://sundhedsdatastyrelsen.dk/da/rammer-og-retningslinjer/om-informationssikkerhed

Europol: ”How criminals profit from the COVID-19 pandemic”: https://www.europol.europa.eu/newsroom/news/how-criminals-profit-covid-19-pandemic



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