The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a call for evidence to collect feedback from stakeholders on the use of designated standards…
MDR: 50 Notified Bodies on NANDO!
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 and IVDR changes officially published
Today, 9 July 2024, Regulation (EU) 2024/1860 was listed in the Official Journal of the EU. After the Council approval on 30 May, the latest…
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: 48th Notified Body on NANDO!
The NANDO database lists a new Notified Body under the MDR, which is the second NB in 2 days! Kiwa Belgelendirme Hizmetleri A.Ş. is overall…
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…
Notified Bodies survey on MDR/IVDR certifications and applications – March update
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 National implementation: Latvia
Latvia has implemented the Medical Devices Regulation 2017/745 (MDR) through its Medical Device Rule No 461 and the Procedures for conducting clinical investigations on medical devices for human…
CE recognition period extended: UK law officially published
On 14 June 2023, the UK Government published The Medical Devices (Amendment) (Great Britain) Regulations 2023. As mentioned in our previous post, Statutory Instrument 2023…