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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
BLOG, Medical Devices

New MHRA guidance on software and AI as a medical device change programme

Software, Artificial Intelligence (AI) included, plays an increasingly important and crucial role in the health…
October 28, 2022
Marketing Obelis SA 2022-10-28T16:29:54+02:00
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
BLOG, Brexit updates, In-Vitro Diagnostics, Medical Devices, Others

The future regulations of medical devices in the United Kingdom

Following Brexit, many changes have been introduced to how medical and in vitro diagnostic devices…
August 23, 2022
Marketing Obelis SA 2022-08-23T16:45:28+02:00
BLOG, news, Others

New UK Plastic Packaging Tax effective from April 2022: what manufacturers and importers need to know

Millions of tonnes of plastic waste is produced and imported into the UK every year…

June 30, 2022
Marketing Obelis SA 2022-06-30T11:15:11+02:00
BLOG, news, Others

New standards protect UK consumers: what businesses and regulators need to know

A standard can be understood as a harmonised way of doing something. It usually contains…

June 9, 2022
Marketing Obelis SA 2022-06-09T15:41:11+02:00
BLOG, Cosmetics, In-Vitro Diagnostics, news

Updates to the UK Toys & Cosmetics Regulations notified to WTO

On April 13, 2022, the United Kingdom notified the draft β€œThe Toys and Cosmetic Products…

May 24, 2022
Marketing Obelis SA 2022-05-24T15:57:26+02:00
BLOG, In-Vitro Diagnostics, Medical Devices

UK and Brexit: towards new Regulations for IVD medical devices

In May 2017, the European Union introduced two new Regulations for medical devices, the Medical…

April 22, 2022
Marketing Obelis SA 2022-04-22T13:12:20+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
    • Medical devices
      • Medical devices & In-vitro diagnostics
    • Cosmetics
      • Cosmetic products
    • Consumer Goods
      • Toys
  • Services
    • Healthcare
      • UK Responsible Person
      • Product Registration
      • Certificate of Free Sales
      • Technical Documentation
      • Approved Body Selection
    • Cosmetics
      • UK Responsible Person
      • Product Formulation
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      • Product Information File
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