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Why the GDPR legislation matters for medical devices

Unitron Regulatory

Why the GDPR legislation matters for medical devices

The General Data Protection Regulation (GDPR, or AVG in Dutch), which came into force in May 2018, is crucial legislation for the protection of personal data within the European Union. While the GDPR applies to a wide range of sectors, its impact on the medical device industry is particularly significant. Here are some reasons why the GDPR legislation is essential for this sector.

1. Protection of sensitive data:

Medical devices often collect and process highly sensitive health data. This includes information about patients’ health status, medical history and treatments. The GDPR ensures that this data is handled in a secure and confidential manner, which is essential to ensure patient privacy.

2. Transparency and consent:

The GDPR requires companies to explain clearly and understandably how they collect, use and store personal data. For the medical device industry, this means that patients are better informed about how their data is processed. Moreover, patients must give explicit consent for the use of their data, which gives them more control over their personal information.

3. Increased accountability and security:

The GDPR forces companies to implement strict security measures to prevent data leaks and unauthorised access. For medical device manufacturers, this means taking robust technical and organisational measures to ensure the security of collected data. This not only helps protect patients’ data but also strengthens trust in the medical technologies used.

4. Consequences for non-compliance:

Fines for non-compliance with the GDPR are significant and can reach up to €20 million or 4% of a company’s annual global turnover, whichever is higher. These severe penalties ensure that companies in the medical device industry take data protection seriously and take the necessary steps to comply with the legislation.


The GDPR legislation plays a crucial role in ensuring the privacy and security of patient data within the medical device industry. By requiring transparency, accountability and stringent security measures, the GDPR helps strengthen patient confidence in medical technologies and protect the integrity of sensitive health data.

Download the General Data Protection Regulation down here

Similar to our version of the Medical Device Regulation, we’ve prepared a better readable version of the GDPR as well. You can download it for free here and use it to your advantage. We’d love to hear how it has helped you!