Obelis European Regulations and compliance updates

An Expert's View about Trade Policy and Regulations in Belgium

Last updated: 24 Feb 2012
News and updates concerning European regulations and new approach directives

Latest news about Obelis European Regulations and compliance updates :
  • Should I work with my importer to register my cosmetic products?

    CE Marking Services and EU Regulatory Consultants - Obelis SA - Wed May 17 16:33:07 UTC 2017

    According to European Regulation EC 1223/2009 (Article 4.1), “Only cosmetic products for which a legal or natural person is designated within the community as ‘responsible […]

  • Cosmetics Notification in the EU: A How-To Guide

    CE Marking Services and EU Regulatory Consultants - Obelis SA - Tue May 16 08:09:38 UTC 2017

    Bringing a new cosmetic product to the European market can, in the minds of some, be a long and arduous process with many hurdles to […]

  • What is a Medical Device according to MDD 93/42/EEC?

    CE Marking Services and EU Regulatory Consultants - Obelis SA - Tue May 09 08:21:29 UTC 2017

    After having defined and explained the Medical Device Classification System in our last blog post, it’s possible that one unexpected question has arisen – what actually […]

  • Basics of the Medical Device Classification System

    CE Marking Services and EU Regulatory Consultants - Obelis SA - Tue May 02 16:44:31 UTC 2017

    For many manufacturers in the industry, medical device classification can be a daunting task to say the least. Determining what device falls into what class, […]

  • How to Obtain a CE Mark (for a Medical Device)

    CE Marking Services and EU Regulatory Consultants - Obelis SA - Wed Apr 26 08:16:33 UTC 2017

    There’s a common misconception among many medical device manufacturers that obtaining a CE mark is too hard, too costly, and too complicated. We’re glad to […]

  • EAR for MDD I (non-measuring, non-sterile) products

    CE Marking Services and EU Regulatory Consultants - Obelis SA - Wed Apr 19 13:04:49 UTC 2017

    An E.A.R. or European Authorized Representative (sometimes known as an EC Rep or EC/CE Representative) is any person naturally or legally established in the European Community who […]

  • What is the CPNP?

    CE Marking Services and EU Regulatory Consultants - Obelis SA - Wed Apr 12 10:10:46 UTC 2017

    The Cosmetics Products Notification Portal (CPNP) is an online notification system for submitting certain technical compliance related information about cosmetic products. It was created for […]

  • What is Eudamed?

    CE Marking Services and EU Regulatory Consultants - Obelis SA - Wed Apr 05 11:03:07 UTC 2017

    Eudamed is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between […]

  • Impact of the New Cosmetics Regulation

    CE Marking Services and EU Regulatory Consultants - Obelis SA - Thu Mar 30 08:33:00 UTC 2017

        The EU Cosmetics Regulation (Regulation (EC) No 1223/2009) has been in place for over three years since it replaced the old EU Cosmetics […]

  • How Much Does CE Marking and Certification Cost?

    CE Marking Services and EU Regulatory Consultants - Obelis SA - Wed Mar 22 10:19:37 UTC 2017

    When it comes to obtaining the CE marking, one of the primary concerns for manufacturers is the financial costs involved in the process. There are […]

Posted: 24 February 2012, last updated 24 February 2012

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