Since the 14th April 2016, the European Parliment has adopted the (EU) n°2016/679 Regulation

The Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data was adopted by The European Parliament on 14 April 2016. The Regulation entered into force on 25 May 2016 for EU Member States, and repeals Directive 95/46/CE on data protection.
Manufactures of medical devices that integrate and process personal data must comply with the requirements of this new regulation.
The key measures of the regulation concern:

  • The clear and explicit consent of data subjects regarding the use of their personal data;
  • The right to be informed in case of data hacking;
  • The right to erase data;
  • Data protection by design;

Companies have until 25 May 2018 to come into compliance with these new requirements.
We will soon be sending out an analysis of theses texts to our nex’inform clients.
Please, do not hesitate to contact us for more information.

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