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Connected medical devices: what are the regulations?

Publié le 12/04/2019

Connected medical devices: what are the regulations?


Regulatory authorities promote Medicine 2.0 through the development of wireless devices. In October 2010, the US Federal Communications Commission and the US Food and Drug Administration (FDA) partnered to encourage investment in wireless healthcare devices, and the European authorities have become increasingly willing to give such solutions the CE marking required on drug products to be sold in Europe.

Despite regulators’ moves to encourage digital innovation, the complex nature of the new types of devices, added to their speed of development, the ways data is used, and who by, means both the life sciences industry and the authorities will have to prepare for change. Policymakers and regulators must keep pace with the innovations emerging across the industry.

medical device regulation

Data collection & medical devices: regulation, labeling and certification

E-health workers all agree that interoperability is paramount. In Europe, like in the United States, a series of regulatory provisions are already used to oversee collecting healthcare data: regulation, labeling, and certification* depending on the respective devices. Benefiting from a validated and functional interoperable system enables healthcare organisations to gain easier access to existing certification defined by the National Authority for Health (HAS) in France.

Their main purpose is:

  • To manage the quality and risks in healthcare teams’ real life daily situations
  • A truly quality ongoing approach thanks to defining priorities of real issues in healthcare providers
  • To respect rules about identity vigilance

*CERTIFICATION is an external evaluation procedure done independently from the healthcare organisation and its governing body. Healthcare professionals appointed by the HAS carry out certification visits using a manual. This repository enables the healthcare organisation’s overall state of operations to be assessed. Implemented by the HAS, the certification procedure takes place every 4 years. Its aim is to give an independent assessment of the quality of the organisation’s services

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