In June 2025, the Medical Device Coordination Group (MDCG) published a new guidance document on performance studies of in vitro diagnostic medical devices under Regulation…
New guidance on MDSW apps on online platforms
The Medical Device Coordination Group (MDCG) just published a new guidance on medical device software (MDSW) available on app platforms. Overall, more than one legislative…
Call for participation: joint clinical assessments of medical devices and EURLs
Today, 28 May, the European Commission published two important calls for stakeholders of the medical devices’ sector. The first published initiative is a call for…
New Manufacturer Incident Report (MIR) form in EU
On 5 May 2025, the European Commission released an updated version of the Manufacturer Incident Report (MIR) form (version 7.3.1). This version will become mandatory…
IVDR: 17th Notified Body on NANDO!
On 1 May 2025, the NANDO database listed a new Notified Body under the IVDR. DNV Product Assurance from Norway is the 17th EU Notified…
IVDR: 16th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! SGS Belgium is the 16th EU Notified Body notified under the Regulation (EU) 2017/746…
IVDR: 15th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. is the 15th EU Notified Body…
Team-NB on IVDR certification process, MDR technical documentation, and AI
On 14 April 2025, Team-NB – the European Association of Medical Devices Notified Bodies – published three position papers addressing different crucial aspects of medical…
New harmonised standards for medical devices and IVDs
On 9 and 10 April 2025, the Official Journal of the EU published references to standards for medical devices. The standards address conformity of medical…
26 May 2025: UDI labelling deadline for medical devices and IVDs in the EU
To comply with the EU Medical Devices Regulations (MDR and IVDR), an important deadline is approaching for labels of medical devices and IVDs. From 26…