Regulatory Affairs

EU Medical Devices Regulation 2017/745 (MDR) preparation support and resources

 

In May 2020, the European Medical Devices Regulation 2017/745 (MDR) will apply in the world’s second-largest medical device market. The new Regulation will introduce major changes to how medical device manufacturers obtain CE Marking and maintain access to the European market, and yet a majority of companies may have yet to prepare for compliance to these new requirements or organize their regulatory transition strategies.

Even though time is limited, Emergo by UL consultants are ready to fully support your CE Marking transition from the Medical Devices Directive (MDD) to the MDR, and can develop your strategy based on your medical device product range, CE Marking certification cycles, Notified Body partnerships, and Supply Chain structure.

 

Key MDR compliance requirements and challenges

 

An effective roadmap to MDR compliance involves multiple components. MDR requirements, such as conformity assessments and sufficient clinical evidence, are more expansive and complex than those of the MDD, which means manufacturers must now address issues including:

Source: Emerge by UL

MDR-Classification-route_Class I - III
MDR-Classification-route_Class I - III

Links:

International Medical Device Regulators Forum

imdrf.org

 


Medical Device Regulatory Consulting Access

 

Link Emergo-Group