The MDR has a new Notified Body – Na Zdrowie!


Although all eyes are on the In Vitro Diagnostic Medical Device Regulation’s (IVDR) Date of Application next week,[1] the Medical Device Regulation (MDR)[2] has been suffering from a shortage of Notified Bodies for almost a year now.

Fortunately, we have some good news to report. Less than two weeks on from the last addition, the 29th Notified Body has been designated under the MDR.[3]

Located in Katowice, TÜV NORD Polska is the first MDR Notified Body in Poland, and will be able to conduct conformity assessments and certification. Hopefully, it will be able to help ease the enormous burden that the existing 28 Notified Bodies have been contending with. We have discussed this workload at length, both in the context of the MDR and in our ‘Spotlight on IVDR’ series.

[1] Regulation (EU) 2017/746
[2] Regulation (EU) 2017/745
[3] Notified Bodies Nando database for the MDR