How can GDPR impact Medical Devices with Erik Vollebregt

Medical Device made Easy Podcast · Sep 14, 2020

There were a lot of discussions about GDPR since its implementation in early 2018. But after a few years, some issues are happening and this may impact the Medical Device Industry.

The EU MDR 2017/745 articles 109 and 110 + EU IVDR 2017/746 articles 102 and 103 are talking about confidentiality and data protection. This means that medical device manufacturers should also follow GDPR.

Recently there was a judgment (SHREMS II) about data protection with Facebook. And even if Facebook’s act is not specifically related to Medical Devices, this judgment is impacting Medical Device companies…