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May Updates

  • It is official: New EU MDR & IVDR enter into force
  • Basics of the Medical Device Classification System
  • New Regulation (EU) 2017/745 on Medical Devices
  • New Regulation (EU) 2017/746 on In-Vitro Diagnostics Devices

  • Two new Regulations on medical devices have been adopted on the 5th April 2017. 
    These 2 regulations replace the existing Directives on medical devices :
    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
    Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
    The new legal framework will fully apply after a transitional period of 3 years after entry into force for the Regulation on medical devices (May 2020) and 5 years after entry into force (May 2022) for the Regulation on in vitro diagnostic medical devices.
    What is new in MDR  and IVDR ?  
    • stricter requirements for manufacturers - person responsible for regulatory compliance

    • stricter role and requirements for authorised representatives - person responsible for regulatory compliance

    • stricter control for high-risk devices - pre-market approval by experts group at EU level (scrutiny mechanism)

    • stricter designation criteria and monitoring by authorities over Notified Bodies

    • Wider definition of medical devices including some aesthetic devices with no medical purpose

    • new risk classification system for in vitro diagnostic medical devices

    • EU wide registration database on medical devices and device Unique Device Identification (UDI) traceability system 

    • Stricter rules on clinical evidence and EU-wide notification for clinical investigations authorizations

    • Stricter post-market surveillance requirements for manufacturers;

    • Better vigilance and market surveillance coordination between member-states