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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