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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, Medical Devices

Proposed UK regulations on Post Market Surveillance requirements

On 21 October 2024, the UK government  laid the Post-market Surveillance (PMS) Statutory Instrument in…
October 28, 2024
Marketing Obelis SA 2024-10-28T16:56:29+01:00
BLOG, Medical Devices

Scotland to ban wet wipes containing plastic

In July 2024, the Scottish Government notified the World Trade Organization (WTO) of a draft…
September 24, 2024
Marketing Obelis SA 2024-09-24T15:24:21+02:00
BLOG, Medical Devices

MHRA Regulatory Strategy on Artificial Intelligence as a medical device

In Spring 2024, the Medicines and Healthcare Products Regulatory Agency (MHRA) unveiled its strategic approach…
June 27, 2024
Marketing Obelis SA 2024-06-27T12:04:26+02:00
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
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
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

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

The content on this website does not provide legal advice and is for information purpose only. Obelis accepts no liability for any inaccuracies or omissions in the information in its website and any decisions based on such are under the sole responsibility of the reader.

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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
      • Product Labelling
      • Product Information File
      • Product Notification
    • Consumer Goods
      • Authorised Representative for Toys
    • Food supplements
      • Food supplements review
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