In General

The European Commission has adopted new regulations on the manufacturing of medical devices and in-vitro diagnostic devices across the EU

What will change?

The new regulations aim to modernise the current system by introducing:

  • stricter ex-ante control for high-risk devices
  • a new risk classification system
  • improved transparency through a device traceability system
  • an “implant card” containing information about a patient’s implanted medical devices
  • reinforced rules on clinical evidence
  • strengthened post-market surveillance requirements for manufacturers
  • improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance

When will it happen?

The regulations will enter into force following a transitional period of three years for medical devices and five years for in-vitro diagnostic devices.

Learn more

The new regulations in a nutshell.

Take a look at the new factsheet available

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