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The application of the EU's delayed medical device regulations will not be affected by qualified CE certification bodies in the short term

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Update time : 2020-07-21 20:57:00

We know that the original European Union’s rules governing medical devices are the "Medical Device Directive" (MDD). On May 25, 2017, after the EU issued the new MDR, it stipulated that the transition period between the old and the old MDD is three years. That is: on May 25, 2020, the MDD will expire soon and the MDR will be on May 26, 2020. Officially implemented on Japan.

Under the MDD and MDR regulations, the scope of qualified NB institutions engaged in CE certification of medical devices is different. The original MDD can do CE certification for 56 NB institutions, but under the new MDR There are roughly 12 NB organizations that do CE certification. It is conceivable that if the MDR is implemented immediately, the number of CE certification agencies will drop sharply, with the consequence that the waiting time for certification is longer and the cost is higher.

The relevant European Commission spokesperson said: "We cannot accept the shortage and delay of medical products that can be marketed and certified. Therefore, the European Commission has adopted a pragmatic strategy to delay the entry into force of the MDR, so as to enable the medical industry All it does is to do what it should do most now: fight the new crown epidemic..."

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