Spanish Notified Body 0318 Applies for EU MDR Redesignation

notified body

Spanish Notified Body 0318 Applies for EU MDR Redesignation

Last week, the Spanish Agency of Medicines and Medical Products (AEMPS) announced it’s notified body (NB) 0318 has begun the process to become designated as NB under the European Union’s medical device regulation (MDR).

AEMPs expects to complete the MDR evaluation and designation process during the second half of 2020.

The assessment process will be lead by the Spain’s Ministry of Health, Consumer Affairs and Social Welfare with a team of competent authorities representing the European Commission (EC) and other member states in verifying the NB’s capacity to conduct conformity assessment activities under MDR.

https://www.aemps.gob.es/informa/notasInformativas/laAEMPS/2019/docs/NI-AEMPS_10-2019-organismo-notificado.pdf

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