The European Commission announced the designation of the first Notified Body under the new Regulation on Medical Devices in the NANDO database!
The first NB that successfully passed all the stages of the designation process is the British BSI (NB 0086). You can consult the scope of the BSI designation here.
This represents good news for the medical device community as it was expected that first NB designations under the MDR will occur only later in 2019. However, it needs to be underlined that first designated NB is based in the UK and in case of a ”no-deal” Brexit scenario – as previously indicated on our blog – UK Notified Bodies will no longer be recognized by the EU as the UK will become a third country.
We will keep you informed on all future developments.
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