# On Medical Device Cybersecurity Compliance in EU

**Authors:** Tuomas Granlund, Juha Vedenpää, Vlad Stirbu, Tommi Mikkonen  
**arXiv:** [2103.06809](https://arxiv.org/abs/2103.06809)  
**Date:** 2021-03-11  
**Summary page:** https://www.summarizepaper.com/en/paper/2103.06809v1/

## Key points

- The European Union has implemented new regulatory requirements for medical device manufacturers
- The Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) have increased regulatory oversight, particularly for medical software, and explicitly address cybersecurity requirements
- These changes present unique challenges for manufacturers to comply with the regulatory framework
- A paper reviews the new cybersecurity requirements in light of available guidance documents and identifies four core concepts for building cybersecurity compliance
- The authors argue that these concepts form a foundation for complying with EU regulations on medical device cybersecurity
- This paper provides valuable insights into navigating the complex landscape of medical device regulation in the EU
- Highlighting the importance of prioritizing cybersecurity in product development.

## Summary

The European Union has implemented new regulatory requirements for medical device manufacturers to ensure the safety and effectiveness of their products. The Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) have increased regulatory oversight, particularly for medical software, and explicitly address cybersecurity requirements. These changes present unique challenges for manufacturers to comply with the regulatory framework. In response, this paper reviews the new cybersecurity requirements in light of available guidance documents and identifies four core concepts for building cybersecurity compliance. The authors argue that these concepts form a foundation for complying with EU regulations on medical device cybersecurity. This paper provides valuable insights into navigating the complex landscape of medical device regulation in the EU and highlights the importance of prioritizing cybersecurity in product development.