Showcase

Updates at the MDR

The new EU Medical Devices Directive (MDR) affects everyone and there are only a few months left before important transition periods for the certification of medical devices expire for manufacturers. This showcase shows you how to successfully implement MDR in simple steps.

Updates at the MDR

The new EU Medical Device Directive MDR affects all: manufacturers, doctors, and dentists, dental technicians, clinics, universities and patients. The MDR has been in force since mid-2017 and has immediate effect. Important transition periods for the certification of medical devices for manufacturers will expire in May 2020, but so far there are only two MDR-approved testing laboratories in Europe, where as one of it is affected by the Brexit.

 

Important innovations come into force

The points include the introduction of the consultation procedure in connection with the clinical evaluation for active Class IIb products that supply or drain medicinal products to the body and Class III implants (Art. 55 MDR), the upgrading of, e.g software, material medical devices, and reusable surgically invasive instruments. Higher requirements are also placed on the QMS and the technical product documentation. Furthermore, post-market data from the improved post-market surveillance process must be included to update the clinical evaluation. New requirements are being placed on the labeling of medical devices, for example with the introduction of a unique product identification number (UDI). In addition, the demands placed on the reprocessing of disposable products have increased.

 

Successful implementation

epmodex GmbH is specialized in supporting its customers in the implementation of the new Medical Devices Regulation. Learn from Martin Epper, Managing Director of epmodex, how epmodex successfully supports its customers in the implementation of the new medical device regulation. He shares his experience from selected projects and shows you in this showcase how to successfully implement MDR in simple steps while avoiding stumbling blocks.

 

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