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…
Team-NB: Notified Body Confirmation Letter to prove application and signed agreement
The latest developments in the implementation of the medical devices and IVD medical devices Regulations (MDR & IVDR) brought significant changes in the transitional phase…
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.…
Q&A on extension of the MDR transitional period and removal of the “sell off” period
Following the publication of the latest amendment to the Medical Devices Regulations (MDR and IVDR), the European Commission published a Q&A document to facilitate 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…
The Council accepts Proposal for extension of legacy period
On March 7, 2023, the Council of the European Union voted in favour of the new transitional provisions for certain medical devices and in vitro diagnostic…
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…
IVDR: 10th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! National Standards Authority of Ireland (NSAI) is the 10th EU Notified Body notified under…
European Parliament accepts Proposal for extension of legacy period
On February 16, 2023, the European Parliament voted in favour of the Proposal to prolong the transitional provisions for certain medical devices and in vitro…
IVDR: 9th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! MDC MEDICAL DEVICE CERTIFICATION GMBH is the 9th EU Notified Body notified under the…