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  • NEWS
  • 2020.07.20

Samsung Medison obtains the intensified CE MDR 10 Months prior to its effective date

 

Samsung Medison has currently obtained the so called MDR (Medical Devices Regulation), which is a new strict regulation for medical devices in Europe in regards to their qualities and safeties. The European CE (Conformite Europeenne) is an international certification that is given to products related to consumers’ safety, health, hygiene, environment and etc. by the European Union Certificate Authority, and that needs to be obtained mandatorily for exporting products to Europe.

In regards to the MDD (93/42/EEC Medical Devices Directive), which is a European medical device regulation that is currently being applied these days after the enactment back in 1993, there were many requests for reinforcement and segmentations to this regulation due to many changes taking place nowadays. To meet these needs and for intensified health protections, the European medical associations have enacted the new medical device regulation “MDR (Medical Devices Regulation) in 2017 with higher and tighter standards of qualities and safeties in medical devices, and is planned to come to effect starting in May 2021. 

Requirements that need to be met by manufacturers with MDR are now to be more concrete and strict by expanding the scope of medical devices, intensifying traceability using UDI(Unique Device Identification), post market monitoring by the Notified Body to reduce the hazards that may occur from unsafe devices, the Notified Body thoroughly investigating manufacturers, setting up systematic clinical evaluations for strict verification of equivalency of medical devices and by enhancing the responsibility of the PRRC(Person Responsible for Regulatory Compliance).

Now that Samsung Medison has obtained this CE MDR which is defined to be a certification that is very strict and difficult to obtain, this means we provide system that complies with and that meets all the requirements of this strict European medical device regulation, providing products to customers with the assurance of their health and safety.

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