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!
Since the 1st of May 2025, the NANDO database has a new Notified Body under the IVDR! DNV Product Assurance from Norway is the 17th EU…
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…
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…
Use of EC REP symbol: ISO standard updated
In March 2025, the International Organization for Standardization (ISO) updated ISO 15223-1:2021 (Amd. 1:2025). This standard describes the the use of symbols for medical devices.…
Have your say on electronic IFUs for medical devices
On 21 February 2025, the European Commission published a public consultation on electronic instructions for use (eIFUs) for medical devices. The consultation is open from…
National analysis of MDR & IVDR: Romania
The Romanian implementation laws of the MDR (Emergency Ordinance no. 46 of 9 June 2021) and of IVDR (Emergency Ordinance no 137 of 12 October…
EMA advice on high-risk medical device clinical development
The European Medicines Agency (EMA), in collaboration with the European Commission, has established a standard procedure for manufacturers of certain high-risk medical devices to request…