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IVDR

  • Eudamed
  • IVDR
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IVDR

What is a significant change? New MDCG Guidance for IVD legacy devices

The new Regulation on in vitro medical devices (IVDR) will start to apply on May 26, 2022. For manufacturers, we want to highlight two crucial…

May 5, 2022
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Simona Varrella 2022-05-05T14:50:21+02:00
IVDR

IVDR: 7th Notified Body on NANDO!

The NANDO database has a new Notified Body under the IVDR! 3EC International a.s. is the 7th EU Notified Body notified under the Regulation (EU) 2017/746…

May 5, 2022
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Simona Varrella 2022-05-05T10:42:32+02:00
IVDR, MDR

EUDAMED: NB, Certificates & UDI/Device registration – Useful documents

Notified Bodies and Certificates The European Commission has released updated documents on the technical documentation relevant for Notified Bodies and the related registration of certificates…

April 12, 2022
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Simona Varrella 2022-04-12T11:20:59+02:00
IVDR

IVDR: Verification of class D IVDs by notified bodies

The Medical Device Coordination Group (MDCG) has published a Guidance establishing the activities of notified bodies in the verification process of class D IVD devices.…

February 17, 2022
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Simona Varrella 2022-02-17T10:27:21+01:00
IVDR

IVDR progressive roll-out has been officially published!

The Official Journal of the European Union (OJEU) has officially listed the amendment of the In Vitro Devices Regulation 2017/746, extending the transitional period for…

January 28, 2022
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regulatory26@obelis.net 2022-01-28T12:20:53+01:00
IVDR

Class D IVDR: Clarification on “first certification for that type of device” by MDCG

The MDCG has endorsed a guidance (updated September 2022) providing clarification on the conditions and corresponding procedures notified bodies need to apply when determining if an expert panel consultation on…

August 18, 2021
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Giorgia de Stefano 2021-08-18T15:54:36+02:00

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