The European Medical Device Management System has been upgraded from Directive MDD(Directive 93/42/EEC for Medical device) to Regulation MDR(Medical Device Regulation (EU) 2017/745).
With the introduction of higher regulation MDR, Companies that have undertaken the work of certification bodies with existing MDD NBs should be re-evaluated by enhanced European authorities on NBs' designation criteria and supervisory procedures. After being evaluated by the European authorities, it must be designated as an MDR NB institution.
Currently (2023.11.09), the list of local Notified Bodies (NB) qualified for MDR assessment and certification is as follows.
Please refer to the list of Notified Body when conducting MDR certification for European medical devices.
EUROPA – European Commission – Growth – Regulatory policy - SMCS
webgate.ec.europa.eu
If you have any questions about medical device in EU,
Please contact us with the below.
info@jnmglobal.net
ra@jnmglobal.net
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