The European Commission has released updated data from the survey conducted among Notified Bodies on certifications and applications under the Medical Devices Regulation (MDR) and…
MDR: 40th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi is the 40th EU Notified Body…
Legacy device manufacturers: Important deadlines & steps
Legacy devices are devices that are typically covered by a valid CE Certificate or are being up-classified by the Regulations and benefit from a special…
MDR: 39th Notified Body on NANDO!
The NANDO database lists a new Notified Body under the MDR! HTCert (Health Technology Certification Ltd) from Cyprus is the 39th Notified Body under the…
MDR: 38th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! SZUTEST Konformitätsbewertungsstelle GmbH is the 38th EU Notified Body under the Regulation (EU) 2017/745…
Team-NB guidance on submission of technical documentation under IVDR
Team-NB has released a new position paper on the best practice guidance for submitting technical documentation under Annexes II and III of the IVDR. To develop…
MDR: 37th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! SLG PRÜF UND ZERTIFIZIERUNGS GMBH is the 37th EU Notified Body under the Regulation…
MDR: 36 Notified Bodies on NANDO
The NANDO database newly listed 36 Notified Bodies under the MDR! ICIM S.P.A. has been the latest NB notified under the Regulation (EU) 2017/745 on…
MDR: 35 Notified Bodies on NANDO
The NANDO database newly listed 35 Notified Bodies under the MDR! INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. has been the latest NB notified under…