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Video: MDR Regulation Postponed Due To Corona
2023 Author: Hannah Pearcy | [email protected]. Last modified: 2023-05-24 11:12
Actually, the new Medical Devices Regulation (MDR) should have come into force on May 26 this year - but the EU Commission has announced that it will postpone the MDR regulation by one year. The background is the COVID-19 crisis, in which delivery bottlenecks and any interruptions in the supply of medical devices are to be avoided.
What the new MDR regulation means
The MDR regulation specifies, among other things, uniform and tightened criteria for the certification of medical devices and regulates the procedure for the approval of clinical trials of medical devices.
The regulation has fundamentally revised the requirements for the CE marking of medical devices. New medical devices of all classes must be assessed according to MDR in order to be placed on the market. Products whose certificates are no longer valid according to the current directive (MDD) also require a new conformity assessment according to MDR.
Christian Erbe, Chairman of the ZVEI Association for Electromedical Technology
ZVEI sees a positive shift
The ZVEI welcomes the declaration of intent by the EU Commission - the current situation already presents the medical technology industry in Germany and Europe with almost insoluble challenges.
"The coronavirus pandemic hits the medical technology industry in a particularly critical phase during the implementation of the MDR," says Christian Erbe, chairman of the ZVEI electrical engineering association. "Under these circumstances, many manufacturers of medical devices, particularly small and medium-sized companies, would not be able to meet their documentation requirements by May 26, 2020," concludes Erbe.
Do not exacerbate bottlenecks
The spread of the corona virus leads to restrictions in the mobility and availability of employees. Failures in supply chains and effects on production can be expected. In addition, the already small number of notified bodies according to MDR can no longer exercise their control function comprehensively and cannot carry out certifications.
"In view of the current situation, it is our task to ensure the availability of the required devices for Covid 19 patients and not to further aggravate existing bottlenecks," said Erbe. Postponing the start of validity is a pragmatic and forward-looking step.