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…
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…
Future UK recognition of devices from EU, US, Canada, and Australia
The Medicines and Health Regulatory Authority (MHRA) has announced on May 21, 2024, the intention to accept medical devices that already conform to regulations in…
Challenges for combined studies of medicines, IVDs, and devices
In the European Union, there are different regulatory requirements for clinical trials of medicinal products, clinical investigations of medical devices, and performance studies of IVDs.…
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: 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…
New MDCG Guidance on content of the Investigator’s Brochure for clinical investigations under MDR
Recently the MDCG (Medical Device Coordination Group) published a guidance on the content of the Investigator’s Brochure for clinical investigations of medical devices (MDCG 2024-5).…
MDR: 45th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! TÜV SÜD Danmark is the 45th EU Notified Body notified under Regulation (EU) 2017/745…
2024: Which MDCG guidance can we expect?
The European Commission has released the updated document on the ongoing work of the MDCG and its subgroups. We present you below some of the…
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…