The NANDO database now includes the NEOEMKI LLC, which brings the total number of notified bodies under Regulation (EU) 2017/745 on medical devices (MDR) to…
IVDR: 13th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! Istituto Superiore di Sanità is the 13th EU Notified Body notified under the Regulation…
MDR: 49th Notified Body on NANDO!
The NANDO database now includes the first Austrian MDR Notified Body, which brings the total number of notified bodies under Regulation (EU) 2017/745 on medical…
MDR: 47th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! MTIC InterCert S.r.l. is the 47th EU Notified Body notified under Regulation (EU) 2017/745…
MDR: 46th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! AFNOR Certification is the 46th EU Notified Body notified under Regulation (EU) 2017/745 on…
MDCG Guidances on vigilance system for CE-marked devices
The Medical Devices Coordination Group (MDCG) has released a new set of guidances on the vigilance systems for CE-marked devices. As such, a template is…
Notified Bodies survey on MDR/IVDR certifications and applications
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…
United Kingdom: CE marking recognition for medical devices and IVDs
Following the government’s decision to extend the CE mark recognition for a wide range of products, the UK announced that for medical devices, the deadlines…
Regulatory lookout: Which other new regulations may be applicable to medtech manufacturers?
The EU is preparing and implementing several new legislations that may impact medical device manufacturers in the upcoming years. We will briefly assess some of…
UK recognises extended CE Certificates
The UK is taking new steps to recognise the extended CE Certificates in light of the recent amendment of the MDR and IVDR transitional periods.…