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IVDR

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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

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!

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…

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
IVDR, MDR

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…

April 10, 2025
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Simona Varrella 2025-04-10T15:58:13+02:00
IVDR, MDR, UDI

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…

March 25, 2025
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Simona Varrella 2025-03-25T18:23:52+01:00

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