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IVDR

New MDCG Guidance on performance studies of IVDs

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…

June 19, 2025
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Simona Varrella 2025-06-19T09:41:06+02:00
IVDR, MDR

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…

June 17, 2025
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Simona Varrella 2025-06-17T15:01:23+02:00
IVDR, MDR, UDI

Guidance on UDI carrier obligation: requirements, implementation, exceptions

The Unique Device Identification (UDI) system under the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) provides for enhanced traceability,…

June 17, 2025
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Georgios 2025-06-17T11:13:28+02:00
UK

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)…

June 11, 2025
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Simona Varrella 2025-06-11T16:51:11+02:00
IVDR, MDR

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…

May 28, 2025
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Simona Varrella 2025-05-28T15:43:39+02:00
IVDR, MDR

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…

May 6, 2025
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Georgios 2025-05-06T15:31:33+02:00
IVDR

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…

May 2, 2025
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Georgios 2025-05-02T12:58:17+02:00
IVDR

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…

April 24, 2025
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Webmasters 2025-04-24T11:55:14+02:00
IVDR

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…

April 22, 2025
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Webmasters 2025-04-22T16:17:38+02:00
IVDR, MDR

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…

April 17, 2025
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Simona Varrella 2025-04-17T11:33:29+02:00
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