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BLOG, In-Vitro Diagnostics, Medical Devices, news

MHRA Updates UK Medical Device & IVD Registration Guidance

Discover key insights for placing medical devices on the UK market post-Brexit. Learn about UKCA and CE marking options, appointing a UK Responsible Person, MHRA registration, and regulatory compliance to access the Great Britain market.

March 17, 2025
Marina Suighi 2025-03-17T14:30:01+01:00
BLOG, In-Vitro Diagnostics, Medical Devices

Latest developments on the future of the UK Medical Devices Regulations

Discover key insights for placing medical devices on the UK market post-Brexit. Learn about UKCA and CE marking options, appointing a UK Responsible Person, MHRA registration, and regulatory compliance to access the Great Britain market.

December 24, 2024
Marketing Obelis SA 2024-12-24T12:56:10+01:00
BLOG, In-Vitro Diagnostics, Medical Devices

Key insights for placing your medical device on the UK market

Discover key insights for placing medical devices on the UK market post-Brexit. Learn about UKCA and CE marking options, appointing a UK Responsible Person, MHRA registration, and regulatory compliance to access the Great Britain market.

November 26, 2024
Maria Manzano 2024-11-26T13:34:35+01:00
BLOG, Cosmetics, In-Vitro Diagnostics

New restrictions for cosmetics in the UK

In April, the UK Government announced several changes to the UK Cosmetics Regulation – some…
April 29, 2024
Marketing Obelis SA 2024-04-29T14:05:26+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
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, In-Vitro Diagnostics, Medical Devices

A quick dive into GMDN and UDI codes

Global Medical Devices Nomenclature (GMDN) is an integral part of the MHRA MD and IVD…
October 11, 2022
Marketing Obelis SA 2022-10-11T16:17:27+02:00

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Obelis UK, Ltd.
Sandford Gate, East Point Business Park
OX4 6LB - Oxford
Company Registration Number: 11742692

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  • Industries
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      • Medical devices & In-vitro diagnostics
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      • Cosmetic products
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      • UK Responsible Person
      • Product Registration
      • Certificate of Free Sales
      • Technical Documentation
      • Approved Body Selection
    • Cosmetics
      • UK Responsible Person
      • Product Formulation
      • Product Labelling
      • Product Information File
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    • Consumer Goods
      • Authorised Representative for Toys
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      • Food supplements review
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