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MDR

  • Eudamed
  • IVDR
  • MDR
  • UDI
  • UK MDR
IVDR, Notified body

IVDR: 19 Notified Bodies on NANDO

On 21 October 2025, SGS FIMKO OY was added to the NANDO database as a notified body for the In Vitro Diagnostic Medical Devices Regulation…

October 22, 2025
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Simona Varrella 2025-10-22T16:21:23+02:00
MDR

Harmonised standards for surgical clothing and drapes, medical face masks and sterilizers

Today, 20 October 2025, the Official Journal of the EU released Commission Implementing Decision (EU) 2025/2078. This Decision amends Implementing Decision (EU) 2021/1182 to include…

October 20, 2025
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Simona Varrella 2025-10-20T17:32:22+02:00
Eudamed, MDR

Updated EUDAMED features: EAR to be notified of new Basic UDI

EUDAMED has recently introduced new features to their system. The database is regularly subject to improvements and updates. In the latest release, EUDAMED has several…

October 17, 2025
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Simona Varrella 2025-10-17T10:50:23+02:00
IVDR, MDR

MedTech industry asks for empowerment of Europe’s innovation ecosystem

The European Commission opened recently a public consultation on the European Innovation Act. This imitative aims at addressing certain issues faced by companies in the…

October 13, 2025
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Simona Varrella 2025-10-13T15:43:48+02:00
MDR, Notified body

MDR: 51 Notified Bodies on NANDO!

As of 7 October 2025, the NANDO database includes NOTICE as a notified body, which brings the total number of notified bodies under Regulation (EU)…

October 7, 2025
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Georgios 2025-10-07T16:45:24+02:00
MDR, UDI

Master UDI-DI for spectacle frames and lenses

On 23 September 2025, the Official Journal of the EU published Commission Delegated Regulation (EU) 2025/1920. This Regulation amends Part C of Annex VI of…

September 24, 2025
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Georgios 2025-09-24T09:42:51+02:00
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

MedTech Europe on simplification of EU digital legislation and State of the Union Address

MedTech Europe recently published two position papers on the latest development on strength, resilience, and competitiveness policies in the medical technology sector. With the first…

September 11, 2025
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Georgios 2025-09-11T17:39:36+02:00
IVDR, MDR

Call for evidence on the targeted revision of EU MDR & IVDR

On 8 September 2025, the European Commission launched a Call for Evidence on the targeted revision of the EU rules for medical devices (MDR) and…

September 9, 2025
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Georgios 2025-09-09T14:50:32+02:00
Eudamed, MDR

EUDAMED: timeline as of August 2025

This summer, the European Commission was expected to announce the functionality of five EUDAMED modules. With this announcement, Actor, UDI/Devices, notified body/certificates as well as…

August 27, 2025
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Simona Varrella 2025-08-27T12:21:11+02:00

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