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…
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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…
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…
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…
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…
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…
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…
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…
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…
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…
MHRA publishes new PSUR format
The MHRA, the UK Medicines and Healthcare products Regulatory Agency, released a new standardised format for the periodic safety update report (PSUR). Dated June 2025,…
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…
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