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…
MHRA guidance on new UK PMS Regulations
The Medical Devices Post-market Surveillance Requirements Regulations 2024 amends the UK Medical Devices Regulations (MDR) 2002 and includes a new section on post-market surveillance (PMS)…
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…
European court case on medical devices classification
The classification of healthcare products in the European Union affects compliance, market access, and regulatory obligations. One of the common challenges involves distinguishing between the…