According to Article 77 of the Medical Devices Regulation (MDR), the sponsor of a clinical…
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…
UK: Extension of CE recognition & Registration of extended Certificates
The UK government announced that it intends to prolong the acceptance of CE marked medical…
MDR & IVDR national implementation: Malta
The Medicines Act 2020 “Medical Devices and In-Vitro diagnostic Medical Devices Provision on the Maltese…
IMDRF latest developments: towards global regulatory harmonisation
International Medical Device Regulators Forum (IMDRF) is a group of regulators specialising in the field…
UK recognises extended CE Certificates
The UK is taking new steps to recognise the extended CE Certificates in light of…
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),…
MDR: 38th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! SZUTEST Konformitätsbewertungsstelle GmbH is…
Amendment to the MDR and IVDR transitional period is official!
Today, 20 March 2023, the Official Journal of the European Union published the latest amendment…
MDR & IVDR national implementation: Croatia
Croatian national laws implementing the Medical Devices Regulation (MDR) 2017/745 and the In Vitro Diagnostics…