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UK MDR

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,…

July 4, 2025
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Simona Varrella 2025-07-04T14:28:45+02:00
UK MDR

New MHRA guidance on classification of DMHTs as software medical devices

On 3 February 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) released a new guidance document to help manufacturers navigate the regulatory landscape…

February 4, 2025
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Georgios 2025-02-04T16:37:50+01:00
IVDR, MDR, Switzerland, UK MDR

2025 deadlines for medtech in the EU, UK, and Switzerland

2025 brings crucial regulatory deadlines for the medtech sector across the EU, UK, and Switzerland. Some of the key dates and requirements that a manufacturer…

January 30, 2025
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Georgios 2025-01-30T17:34:08+01:00
UK MDR

Future UK medical devices regulation: Roadmap

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released Version 2.0 of its Medical Devices Regulatory Reform Roadmap, providing a detailed timeline for…

December 13, 2024
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Georgios 2024-12-13T12:56:29+01:00
IVDR, MDR

Future UK recognition of devices from EU, US, Canada, and Australia

The Medicines and Health Regulatory Authority (MHRA) has announced on May 21, 2024, the intention to accept medical devices that already conform to regulations in…

May 27, 2024
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Simona Varrella 2024-05-27T11:30:10+02:00
IVDR, MDR

Regulatory updates: January 2024

With the start of 2024, the EU, UK, and Swiss competent authorities provided new regulatory documents. In this post, we will provide an overview of…

January 12, 2024
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Pablo De Mingo Monge 2024-01-12T14:25:44+01:00
IVDR, MDR

CE recognition period extended: UK law officially published

On 14 June 2023, the UK Government published The Medical Devices (Amendment) (Great Britain) Regulations 2023. As mentioned in our previous post, Statutory Instrument 2023…

June 19, 2023
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Pablo De Mingo Monge 2023-06-19T16:20:42+02:00

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