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NEWSLETTER

enpl

Created: 04/04/2019

On 2nd and 3rd of April, in Brussels took place the 60th meeting of the NB-MED working group bringing together notified bodies certifying medical devices and in vitro diagnostic medical devices. The meeting was attended by two representatives of the Polish Centre for Testing and Certification S.A.

The meeting raised important issues regarding Brexit, the current status of the process of designating notified bodies in accordance with the new European Commission regulations regarding medical devices and IVD medical devices. The subject of access to the still created European electronic database collecting information on medical devices (EUDAMED) and the topic concerning drafts of future guidelines of the European Commission regarding, inter alia, the interpretation of classification rules of IVD medical devices were discussed in detail.

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