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…
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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…
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…
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…
MDCG update: classification revision of SARS-CoV-2 tests
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…
Team-NB statement on certificates with conditions
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)…
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.…
UK government response to consultation on medical devices regulations: key takeaways for manufacturers
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…
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