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Medical devices and healthcare

Rapid Antigen Tests use across Europe: Council of the European Union’s Recommendation

Council of the European Union adopted on a Recommendation on a common framework for the use and validation of rapid antigen tests and the mutual recognition of COVID-19 test results in the EU

February 5, 2021
Marketing 2021-02-05T08:39:27+01:00
Natural cosmetic products photoshoot
Beauty and personal care

New marking specifications for single-use plastic products -impact on cosmetic industry-

The impact of The Single-Use Plastic Directive (EU) 2019/904 on the cosmetic industry. Learn more about it in this article.

February 1, 2021
Marketing 2021-02-01T14:14:00+01:00
A picture of lit candle
Beauty and personal care, Consumer goods, Medical devices and healthcare, Medical devices and healthcare auto

Regulating Toxic Chemicals: Safer Tattooing Inks and Permanent Makeup for a Safer EU Market

In order to protect the EU citizens’ health and to create a safer Internal Market, the Commission adopted new restrictions under the EU legislation governing chemicals.

January 25, 2021
Marketing 2021-01-25T12:23:16+01:00
Computer motherboard
Medical devices and healthcare, Medical devices and healthcare auto, Technology and innovation

How MDR regulates software?

Artificial Intelligence (AI) has been used more and more in healthcare. Read our article to learn more about the challenges that manufacturers have to deal

January 21, 2021
Marketing 2021-01-21T14:56:29+01:00
Natural cosmetic products photoshoot
Beauty and personal care

Leave-on hydroalcoholic hand gels: which claims are not authorized?

A guide for product claims for leave-on hydroalcoholic hand gels in the COVID-19 pandemic was published, find the specifications here!

January 19, 2021
Marketing 2021-01-19T11:32:18+01:00
Natural cosmetic products photoshoot
Beauty and personal care

EU Court rules on Cosmetics Labelling and importance of Product’s Function and Label Translation

The CJEU delivered a preliminary ruling on the interpretation of the requirements applicable to the labelling of cosmetic products. Find out all the details here!

January 7, 2021
Marketing 2021-01-07T11:48:00+01:00
Natural cosmetic products photoshoot
Beauty and personal care

Alternatives to animal testing: the ways forward

The EPPA’s projects aim to ease the dissemination of the information and scientific evidence about the alternatives to animal testing, and to enhance cooperation among the experts, decision-makers and business owners.

January 4, 2021
Marketing 2021-01-04T15:21:17+01:00
A picture of lit candle
Consumer goods, Medical devices and healthcare, Medical devices and healthcare auto

IVDR: MDCG Guidance on classification of in vitro diagnostic devices & proposed symbols for specific IVDs

Guidance on Classification Rule for in vitro Diagnostic Medical Devices aims to uniformly apply the classification rules stated in the new regulatory framework

January 4, 2021
Marketing 2021-01-04T12:41:03+01:00
A professional uses an ultrasound machine
Medical devices and healthcare, Medical devices and healthcare auto

Surgical masks: Belgium lifts exceptional measures

From February 1, 2021, it will be no longer possible to place surgical masks on the Belgian market demonstrating minimum quality following the ATP nor alternative

January 4, 2021
Marketing 2021-01-04T12:28:26+01:00
Consumer goods, Webinars and events

Sustainable products, environmental labels, ‘’right to repair’’?

European Commission’s European Green Deal aims at transforming production and consumption of products on the EU market, in order for them to become more durable, resilient and eco-friendly.

December 23, 2020
Marketing 2020-12-23T16:49:03+01:00
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Obelis Group
+32 (0) 2 732 59 54
hello@obelis.net 

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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
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      • GS Mark Certification
  • Locations
    • Switzerland
    • United Kingdom
    • United States
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  • Databases
    • Medical Devices – MDlaw.eu
    • Cosmetics – COSlaw.eu
    • Other Products – PRODlaw.eu
  • News
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