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…
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…
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…
On 14 April 2025, Team-NB – the European Association of Medical Devices Notified Bodies – published three position papers addressing different crucial aspects of medical…
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…
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…
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…
Today, 18 March 2025, MDCG just released a new version of MDCG 2020-16. This guidance addresses the classification of in vitro diagnostic medical devices under…
On 12 March 2025, Team-NB released a statement on certificates with conditions. The EU Medical Device Regulation (MDR) 2017/745 and the In-Vitro Diagnostic Regulation (IVDR)…
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.…
On 26/02/2025, the UK government published its response to the public consultation on proposed amendments to the Medical Devices Regulations 2002 concerning four specific pieces…
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…
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…
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