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Beauty and personal care, Consumer goods, Industrial and mechanical, Medical devices and healthcare, Medical devices and healthcare auto, Technology and innovation

What is CE Marking?

A definitive guide to CE marking in Europe. Discover what a CE marking is, what products require a CE mark, and why a CE mark is required on the EU market.

April 26, 2023
Marketing 2023-04-26T14:40:53+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
Beauty and personal care, Medical devices and healthcare, Medical devices and healthcare auto, Webinars and events

Obelis partner regulatory training: takeaways from Chemron FDA Korea

An interview with Sarah You about her experience in following one of our expert’s professional trainings on EU Regulations and the insights she gained from it.

January 24, 2023
Siana Slavova 2023-01-24T12:45:38+01:00
Consumer goods, Industrial and mechanical, Medical devices and healthcare auto

Upcoming restrictions for single-use plastic packaging (PFAS) in Belgium

In November 2022, the Belgian government notified the EU of a draft Royal Decree to limit the placing on the market of single-use plastic products. Read all the details in our article!

January 23, 2023
Siana Slavova 2023-01-23T16:47:11+01:00
Consumer goods, Medical devices and healthcare, Medical devices and healthcare auto, News

What manufacturers need to know about the new extensions for legacy devices

There was a general agreement between the Council of the EU representing the EU Member States and the European Commission to extend the transitional period (legacy period) to the Medical Devices Regulation (MDR). Read all the details in our article!

January 23, 2023
Siana Slavova 2023-01-23T13:21:35+01:00
Medical devices and healthcare auto, Webinars and events

Webinar: EUDAMED Actor & Device registration

Register and learn all the details about EUDAMED, the European database for medical devices and In-vitro diagnostics!!

January 9, 2023
Siana Slavova 2023-01-09T15:15:32+01:00
Medical devices and healthcare, Medical devices and healthcare auto

What is new in the European Standardisation system?

To modernise the European Standardisation System, the European Commission proposed to amend the Standardisation Regulation as part of its European Standardisation Strategy of February 2, 2022. Read all the details in our article!

December 20, 2022
Siana Slavova 2022-12-20T14:27:41+01:00
Medical devices and healthcare auto, Webinars and events

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

Register for our new live webinar about MDR and IVDR! On December 19, at 3:00 pm (Beijing Time), in collaboration with TÜV SÜD and AKRA TEAM GmbH!

December 7, 2022
Siana Slavova 2022-12-07T16:20:48+01:00
Medical devices and healthcare, Medical devices and healthcare auto

European Authorised Representative (EAR) for manufacturers based in Turkey

There are few direct implications to the Customes Agreements for manufacturer of medical devices from Turkey. Read all the details in our article!

November 17, 2022
Siana Slavova 2022-11-17T17:16:30+01:00
Medical devices and healthcare auto, Technology and innovation

New Proposal from the EU Commission for a Cyber Resilience Act

European Commission presented a proposal for a Regulation on cybersecurity requirements for products. Read more!

November 16, 2022
Siana Slavova 2022-11-16T15:57:16+01:00

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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
      • Medical Devices
      • In-Vitro Diagnostics
      • Aesthetic Devices
    • Cosmetics
      • Cosmetic Products
    • Food Supplements
      • Food Supplements Products
    • Other Products
      • Electronics
        • Electromagnetic Compatibility
        • Low-Voltage Products
        • Radio Equipment
      • General Products
      • Toys and children’s products
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      • Machinery
      • Motor Vehicles
      • Equipment for Explosive Atmospheres (ATEX)
      • Pressure Equipment
      • Personal Protective Equipment (PPE)
    • Technology & Innovation
      • Horizon 2020
      • Horizon Europe
  • Services
    • Medical
      • EU Authorised Representative
      • EU Product Registration
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      • Technical File Review
      • Derogation for expired CE Certificates
      • GMDN and EMDN codes research
      • HSC IVD List– Registration of COVID tests
      • Notified Body Selection and Negotiation
      • Testing for Medical Devices
      • Consultancy
      • Trainings
    • Cosmetics
      • EU Responsible Person
      • Formulation Review
      • Labelling Review
      • Product Information File
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