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IVDR

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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
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
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
IVDR, MDR

MedTech Europe calls for aligned implementation of AI Act with MDR & IVDR

In its press release,  published on 1 August 2025, marking one year since the entry into force of the Artificial Intelligence (AI) Act, MedTech Europe…

August 7, 2025
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Georgios 2025-08-07T11:32:54+02:00
IVDR, MDR, UK MDR

UK Proposal to improve medical devices access in Great Britain

On 22 July 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced a proposal to improve access to medical devices for patients in…

July 23, 2025
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Simona Varrella 2025-07-23T17:15:53+02:00
IVDR, Notified body

IVDR: 18th Notified Body on NANDO!

On 17 July 2025, the NANDO database listed a new Notified Body under the IVDR. POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. from Poland is the…

July 18, 2025
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Georgios 2025-07-18T11:51:33+02:00
IVDR, MDR

Updated EU Regulation on electronic IFUs of medical devices

On 26 June 2025, the Official Journal of the EU published Commission Implementing Regulation (EU) 2025/1234. The Regulation amends Commission Implementing Regulation (EU) 2021/2226 published…

June 26, 2025
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Simona Varrella 2025-06-26T16:02:52+02:00
IVDR, MDR

AI medical devices: how the AI Act impacts the MDR and IVDR

In June 2025, the MDCG published its sixth new guidance of the year: MDCG 2025-26. This document provides answers on certain aspects of the interplay…

June 24, 2025
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Simona Varrella 2025-06-24T17:47:42+02:00

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