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BLOG, Medical Devices

UK to recognize medical devices compliant with EU, US, Australia, and Canada

In May 2024, the United Kingdom government announced the objective to accept medical devices compliant…
May 30, 2024
Marketing Obelis SA 2024-05-30T09:41:59+02:00
A person checking a digital label.
BLOG, In-Vitro Diagnostics, Medical Devices

Digital labels to become reality in the United Kingdom

In January 2024, the United Kingdom announced further measures to ease regulatory obligations for companies.…
March 21, 2024
Marketing Obelis SA 2024-03-21T09:32:47+01:00
BLOG, Brexit updates, Medical Devices, news

Status of CE and UKCA marking use in the United Kingdom

Since Brexit came into force in 2021, the legislation of the European Union does not…
February 26, 2024
Marketing Obelis SA 2024-02-26T14:39:28+01:00
BLOG, Medical Devices, news

Implementation status of the future regulatory framework for medical devices

The current regulatory framework for medical devices in Great Britain is the UK MDR. Since…
January 26, 2024
Marketing Obelis SA 2024-01-26T14:33:30+01:00
BLOG, Medical Devices, news

AI-Airlock regulatory sandbox to support AI medical devices industry

Artificial Intelligence in healthcare is revolutionising the way of diagnosing, treating, and monitoring patients. Its…
November 9, 2023
Marketing Obelis SA 2023-11-09T15:01:49+01:00
In-Vitro Diagnostics, Medical Devices

UK to align with the latest EU extended provisions: CE-marked devices on the market after 30 June 2023

The United Kingdom is expected to have a revised UK Medical Devices Regulation (MDR) applicable…
May 31, 2023
Marketing Obelis SA 2023-05-31T12:31:20+02:00
In-Vitro Diagnostics, Medical Devices

MHRA Policy Paper on Medical Technology strategy: a future MedTech landscape for the UK medical sector

Medical technology, also called “MedTech", is a vital part of the healthcare system. It includes…
April 7, 2023
Marketing Obelis SA 2023-04-07T11:30:31+02:00
In-Vitro Diagnostics, Medical Devices

Approved Bodies for medical devices: UK improving conformity assessment capacity in a post-Brexit landscape

Brexit and the separation of the United Kingdom from the EU have significantly affected a…
February 27, 2023
Marketing Obelis SA 2023-02-27T16:25:20+01:00
BLOG, Brexit updates, In-Vitro Diagnostics, Medical Devices, Others

Use of CE marking in the United Kingdom: new extensions for manufacturers

The CE marking proves that goods on the EU market meet the applicable regulatory requirements.…
November 28, 2022
Marketing Obelis SA 2022-11-28T18:26:23+01:00
BLOG, Brexit updates, Medical Devices

First UK Approved Body since Brexit to be designated by the MHRA

One more step towards a strong UKCA regulatory framework for Medical After the withdrawal of…
November 10, 2022
Marketing Obelis SA 2022-11-10T12:12:31+01:00

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  • Industries
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      • Medical devices & In-vitro diagnostics
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      • UK Responsible Person
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      • Approved Body Selection
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      • UK Responsible Person
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