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Close-up of a medical device
Medical devices and healthcare, Webinars and events

Webinar: (New)MDR Legacy extension: EU, UK and CH

Register to our new webinar to learn about the MDR Legacy extension in EU, UK and CH. Register now!

July 7, 2023
Dimitra Kagioglou 2023-07-07T09:49:00+02:00
Shelf in a cosmetics store
Beauty and personal care, News

New restrictions for Butylated Hydroxytoluene (BHT) and Acid Yellow 3 apply as of July 2023

Introducing new restrictions for Butylated Hydroxytoluene (BHT) and Acid Yellow 3 in cosmetic products, the Commission Regulation (EU) 2022/2195 brings changes to the industry

June 23, 2023
Dimitra Kagioglou 2023-06-23T12:43:35+02:00
An extensive array of servers
Medical devices and healthcare

EU to have the world’s first comprehensive law on Artificial Intelligence by end of 2023

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

June 21, 2023
Dimitra Kagioglou 2023-06-21T16:31:23+02:00
A hospital bed equipped with a monitor
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
Dimitra Kagioglou 2023-06-06T14:23:04+02:00
Employee in a reflective vest reading a tablet
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
Dimitra Kagioglou 2023-05-26T11:22:30+02:00
USA flag
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
Dimitra Kagioglou 2023-05-11T16:26:01+02:00
Attendees in a conference room
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
Dimitra Kagioglou 2023-05-05T12:07:43+02:00
The Sydney Opera House and Sydney Harbour Bridge
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
Dimitra Kagioglou 2023-05-03T15:37:33+02:00
Black CE mark on paper
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
Selling medical devices online in the EU .The image display an example of medical device.
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
Dimitra Kagioglou 2023-04-13T17:27:12+02:00
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Obelis Group
+32 (0) 2 732 59 54
hello@obelis.net 

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Bd Général Wahis 53
B-1030 Brussels, Belgium
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Boulevard Brand Whitlock 30
B-1200 Brussels, Belgium

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.

© obelis.net | lennarthorst.com
  • 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
      • Construction Products
      • Machinery
      • Motor Vehicles
      • Equipment for Explosive Atmospheres (ATEX)
      • Pressure Equipment
      • Personal Protective Equipment (PPE)
    • Technology & Innovation
      • Horizon 2020
      • Horizon Europe Compliance Support
  • Services
    • Medical
      • European Authorised Representative (EAR)
      • EU Product Registration
      • Legal Representation for Clinical Investigation
      • National Registration
      • EUDAMED Registration
      • Free Sales Certificate (FSC)
      • Technical File Review
      • Interruption of Supply Notification
      • Derogation for expired CE Certificates
      • GMDN and EMDN codes research
      • Registration of COVID tests
      • Notified Body Selection and Application
      • Quality Management System Support
      • Testing for Medical Devices
      • Consultancy
      • Trainings
    • Cosmetics
      • EU Responsible Person
      • Formulation Review
      • Labelling Review
      • Product Information File
      • Safety Assessment
      • Lab Testing
      • CPNP Notification
      • Post-Market Surveillance
      • Packaging Recycling Symbols
      • Canadian Safety Evidence Compilation
      • Canadian Formula and Label Review
      • Canadian Responsible Person
      • Canadian Digital Contact Point
      • Canadian Incident Reporting
      • Trainings
    • Food Supplements
      • Food supplements review
    • Other Products
      • Electronics
      • General Products
      • Toys
      • Market Surveillance & Compliance of Products
      • Construction Products
      • Equipment for Explosive Atmospheres (ATEX)
      • Machinery
      • Personal Protective Equipment (PPE)
      • Pressure Equipment
      • Motor Vehicles
    • More Services
      • General Data Protection (GDPR)
      • Legal services
      • Trademark registration
      • Creation of Regulatory Content
      • GS Mark Certification
  • Locations
    • Switzerland
    • United Kingdom
    • United States
    • European Union
  • Databases
    • Medical Devices – MDlaw.eu
    • Cosmetics – COSlaw.eu
    • Other Products – PRODlaw.eu
  • News
  • Careers
Schedule a call
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© obelis.net | lennarthorst.com