EU Medical Device In Vitro Diagnostic Medical Device Regulations November 2017

The EU’s Regulation (EU) 2017/745 (Medical Device Regulation (MDR)) came into force on 25 May 2017 and will replace the EU’s current Medical Device Directive (93/42/EEC) and the Directive on active implantable medical devices (90/385/EEC).

Manufacturers of currently-approved medical devices will have a transition time of three years until May 26th 2020 to meet the requirements of the MDR. For some manufacturers the MDR provides an additional time after the date of application allowing them to place new products for a maximum 4 more years on the market. Additional requirements will apply for this extended transition period.

The MDR differs in several important ways from the EU’s current directives for medical devices and active implantable medical devices. Changes in the Regulation include expansion of the scope of products covered, more rigorous requirements for clinical evaluation including changes to clinical investigations, mandatory unique device identification (UDI) mechanisms, and increased post-market oversight by EU Notified Bodies.

In addition, the EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) entered into force on 26 May 2017 and will replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC). The Regulation has a transition period of 5 years with full application of the Regulation in 2022.

The IVDR differs in several important ways from the EU’s current directive for in vitro diagnostic medical devices as follows: product scope expansion; reclassification of devices according to risk; more rigorous clinical evidence requirements; more stringent documentation; identification of “person responsible for regulatory compliance”; implementation of unique device identification; more rigorous surveillance by Notified Bodies; greater scrutiny of Notified Bodies; no “grandfathering” provisions.

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