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MDR

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MDR, Switzerland

Switzerland aligns with the EU on new eIFUs regulation

In August 2025, Swissmedic announced to adopt the new EU requirements on eIFUs with immediate effect. With this alignment, it is possible to use electronic…

August 25, 2025
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Simona Varrella 2025-08-25T14:14:58+02:00
MDR, Switzerland

Swissdamed device registration module is now available

In August 2025, Swissmedic announced the new UDI Devices module in Swissdamed is live. The registration is voluntary and will become mandatory only in July…

August 19, 2025
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Simona Varrella 2025-08-19T15:30:29+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
MDR

MDCG on timelines to implement Master UDI-DI

On 10 July 2025, the Medical Device Coordination Group (MDCG) released a position paper to clarify the timelines of the implementation of the Master UDI-DI…

July 14, 2025
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Simona Varrella 2025-07-14T11:32:32+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
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

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