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IVD

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  • IVDR
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IVDR, MDR, UK MDR

MHRA call for evidence on designated standards for medical devices and IVDs

The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a call for evidence to collect feedback from stakeholders on the use of designated standards…

September 15, 2025
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Georgios 2025-09-15T11:58:49+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
IVDR

IVDR: 13th Notified Body on NANDO!

The NANDO database has a new Notified Body under the IVDR! Istituto Superiore di Sanità is the 13th EU Notified Body notified under the Regulation…

September 11, 2024
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Webmasters 2024-09-11T15:07:02+02:00
IVDR, MDR

MDR and IVDR changes officially published

Today, 9 July 2024, Regulation (EU) 2024/1860 was listed in the Official Journal of the EU. After the Council approval on 30 May, the latest…

July 9, 2024
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Simona Varrella 2024-07-09T10:10:06+02:00
IVDR

Team-NB issues recommendations on the classification of SARS-CoV-2 IVDs

Team-NB, the European Association of Medical Devices Notified Bodies, has released a position paper providing recommendations for manufacturers of IVDs intended to detect the presence or the…

February 27, 2024
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Pablo De Mingo Monge 2024-02-27T15:32:03+01:00
IVDR

IVDR: 12th Notified Body on NANDO!

  The NANDO database has a new Notified Body under the IVDR! Sertio Oyis the 12th EU Notified Body notified under the Regulation (EU) 2017/746…

October 31, 2023
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Webmasters 2023-10-31T10:39:08+01:00
IVDR

IVDR: 11th Notified Body on NANDO!

The NANDO database has a new Notified Body under the IVDR! Eurofins Electric & Electronics Finland Oy is the 11th EU Notified Body notified under…

September 18, 2023
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Pablo De Mingo Monge 2023-09-18T11:56:45+02:00
IVDR

Team-NB guidance on submission of technical documentation under IVDR

Team-NB has released a new position paper on the best practice guidance for submitting technical documentation under Annexes II and III of the IVDR. To develop…

March 1, 2023
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Pablo De Mingo Monge 2023-03-01T14:48:16+01:00
IVDR

IVDR: 10th Notified Body on NANDO!

The NANDO database has a new Notified Body under the IVDR! National Standards Authority of Ireland (NSAI) is the 10th EU Notified Body notified under…

February 20, 2023
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Pablo De Mingo Monge 2023-02-20T10:58:52+01:00
IVDR

IVDR: 9th Notified Body on NANDO!

The NANDO database has a new Notified Body under the IVDR! MDC MEDICAL DEVICE CERTIFICATION GMBH is the 9th EU Notified Body notified under the…

February 16, 2023
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Pablo De Mingo Monge 2023-02-16T12:13:12+01:00

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