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Medical devices and healthcare

Classification of medical device software in the European Union

Discover the new GDPR obligations for businesses and organizations within the EU and UK!

June 6, 2023
Siana Slavova 2023-06-06T14:23:04+02:00
Medical devices and healthcare

Products falling under the General Product Safety Directive (GPSD): compliance process with the new Regulation from 2024

On 23 May 2023 the Official Journal of the EU published a new law, the General Product Safety Regulation (GPSR). From 13 December 2024, manufacturers will have to comply with the new GPSR.

May 26, 2023
Siana Slavova 2023-05-26T11:22:30+02:00
News

MoCRA deadlines you need to keep in mind when selling cosmetic products in the U.S.

MoCRA deadlines you need to keep in mind when selling cosmetic products in the U.S

May 11, 2023
Siana Slavova 2023-05-11T16:26:01+02:00
News

Obelis Wins a Second Trends Gazelle Award: Growing from Medium-Sized to Big Enterprises Category

Obelis Wins a Second Trends Gazelle Award.Growing from Medium-Sized to Big Enterprises CategoryWant to know more? Visit our page!

May 5, 2023
Siana Slavova 2023-05-05T12:07:43+02:00
Medical devices and healthcare, Webinars and events

Webinar: Steps to enter the Australian market for Medical Devices

Manufacturers! Interested in the European Commission proposal for legacy devices? Our consultant will be offering an interpretation of the European Commission proposal for legacy devices regarding the following date: March 20, 2023

May 3, 2023
Siana Slavova 2023-05-03T15:37:33+02:00
IVD's, Medical devices and healthcare

Selling medical devices online in the EU

Complying with the rules on distance selling of medical devices and in vitro diagnostics device is a fundamental step when a manufacturer chooses to sell the devices online.

April 13, 2023
Siana Slavova 2023-04-13T17:27:12+02:00
News, Webinars and events

Obelis Group to support small medical device companies in Luxemburg’s Fit 4 Innovation Programme as Regulatory Consultant

We are thrilled to announce that Obelis Group has been chosen as one of the regulatory consultants for the Luxemburgish Ministry of Economy’s Fit 4 Innovation

April 11, 2023
Siana Slavova 2023-04-11T10:49:17+02:00
Beauty and personal care

The biggest amendment of the U.S. Cosmetics Law since 1938

The US government issued the Modernisation of Cosmetics Regulation Act (MoCRA) of 2022, which will apply as of December 29, 2023.

April 5, 2023
Siana Slavova 2023-04-05T13:35:25+02:00
Medical devices and healthcare, Webinars and events

Seminar: Placing Medical Devices and In-Vitro Diagnostic Devices on the Union Market (EU) – News and Challenges

Medical Device and In-vitro Diagnostic Industry Discussion: Key Takeaways on IVDR and MDR Implementation Challenges

March 27, 2023
Siana Slavova 2023-03-27T09:45:08+02:00
Consumer goods, Medical devices and healthcare, Medical devices and healthcare auto

Covid tests under IVDR – How to sell them on the EU market?

The new EU Regulation on in vitro diagnostic devices (IVDR), applicable since May 26, 2022, affected the classification and compliance process of COVID-19 tests.

February 24, 2023
Siana Slavova 2023-02-24T12:30:23+01:00

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Obelis Group
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  • Industries
    • Medical
      • Medical Devices
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    • Food Supplements
      • Food Supplements Products
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