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BLOG, Brexit updates, Medical Devices

The future of the UK Medical Devices regulatory regime

An insight on the Medicines and Healthcare products Regulatory Agency Delivery Plan 2021-2023 and the…

August 30, 2021
Marketing Obelis SA 2021-08-30T15:38:01+02:00
BLOG, Brexit updates, Medical Devices

Update on technical specification for transparent face masks

Since the beginning of the pandemic of Covid-19, the usage of face mask has increased,…

August 30, 2021
Marketing Obelis SA 2021-08-30T15:36:40+02:00
BLOG, Medical Devices, Others

COVID-19 medical devices exceptionally authorised on the UK market: updated list

Due to the COVID-19 outbreak, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has…

July 14, 2021
Marketing Obelis SA 2021-07-14T14:17:01+02:00
Medical Devices, Others

COVID-19: specifications for rapid breath tests for detection of SARS-CoV-2 in the UK

Following the Covid-19 crisis and the consequent surge in the demand of Covid test kits,…

June 17, 2021
Marketing Obelis SA 2021-06-17T09:44:53+02:00
Medical Devices, Others

MHRA allows DEHP phthalates in medical devices

Changes are changes, are they not? Brexit being a reality, it can now be presumed…

June 16, 2021
Marketing Obelis SA 2021-06-16T15:03:41+02:00
Medical Devices, Others

Free standard & public consultation on community face coverings standard

COVID-19, COVID-19… Needless to say, it is everyone’s duty to tackle and eliminate the virus…

June 16, 2021
Marketing Obelis SA 2021-06-16T14:41:27+02:00
Medical Devices, Others

MHRA update to the guidance on the regulatory status of software (including apps) used in the diagnosis, treatment and management of patients with COVID-19

The Medicines and Healthcare products Regulatory Agency (MHRA) is the standalone regulator for medicines and…

May 27, 2021
Marketing Obelis SA 2021-05-27T14:39:11+02:00
Medical Devices, Others

What to know about the UKCA marking

On 1 January, 2021, the United Kingdom left the EU Single Market, meaning that goods…

May 7, 2021
Marketing Obelis SA 2021-05-07T16:00:32+02:00
Medical Devices

Prosthetic/Orthotic Devices and Ophthalmic products: requirements from the UK MDR

Are you thinking about placing external prostheses and orthoses devices, or even ophthalmic products on…

May 4, 2021
Marketing Obelis SA 2021-05-04T16:18:45+02:00
Brexit updates, Cosmetics, In-Vitro Diagnostics, Medical Devices

The UK market after Brexit – The end of grace periods for registering your MDD&IVDs and Cosmetics is approaching quickly

Manufacturers of medical devices, IVDS, and cosmetics, are you aware of the new UK requirements…

March 4, 2021
Marketing Obelis SA 2021-03-04T16:04:59+01:00

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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
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      • UK Responsible Person
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