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Restricted Substances EU MDR

Medical Devices placed on the EU market must comply with both the Medical Devices Regulation (MDR) 2017/745/EU and the Restriction of the use of certain Hazardous Substances (RoHS) Directive 2011/65/EU and its amendments. Both include substance restrictions but the approaches used are very different.

Use of Retrospective RWD for MDR Compliance

As EU MDR has already entered into force and will be applicable in May 2020,the device companies are getting geared up to be MDR compliant. EU MDR enforces stringent requirements related to clinical evidence.

UDI in new EU MDR

Unique Device Identification (UDI) is intended to assign a unique identifier to medical devices within the United States it marks and identifies individual medical devices throughout their distribution and product life.

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