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BLOG, In-Vitro Diagnostics, industry, Medical Devices, news

UK PMS Regulations applicable from June 2025

From 16 June 2025, the Medical Devices Post-market Surveillance (PMS) Regulations apply to medical devices and IVDs placed on the market in Great Britain. Published in 2024, the new UK PMS Regulations amends the UK Medical Devices Regulations (MDR) 2002.

June 24, 2025
Marina Suighi 2025-06-24T16:51:12+02:00
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, 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, 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
BLOG, news

UK Recognises extended CE Certificates

The UK Government has taken steps towards recognizing extended CE Certificates in light of the…
April 5, 2023
Marketing Obelis SA 2023-04-05T17:11:11+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
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      • Cosmetic products
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  • Services
    • Healthcare
      • UK Responsible Person
      • Product Registration
      • Certificate of Free Sales
      • Technical Documentation
      • Approved Body Selection
    • Cosmetics
      • UK Responsible Person
      • Product Formulation
      • Product Labelling
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