Market Surveillance & Compliance of Products

Non-European manufacturers are strongly encouraged to appoint a professional European Authorised Representative. This allows to stay informed about necessary documentation, applicable standards, or ongoing changes in the applicable requirements relating to the product.

Obelis, located within walking distance of the European Commission, acts as your Authorised Representative in Europe and Switzerland and as Responsible Person in the United Kingdom.

Ensuring Compliance in the EU

Aside from all the obligations that the AR has, in respect to the Union harmonisation legislation applicable to a certain type of products, this Regulation lays out additional tasks for the AR:

  • To verify that the EU declaration of conformity or declaration of performance and technical documentation have been drawn up
  • To keep the declaration of conformity or declaration of performance at the disposal of market surveillance authorities for the period required by that legislation and ensure that the technical documentation can be made available to those authorities upon request;
  • Upon a reasoned request from a market surveillance authority, to provide them with all information and documentation necessary to demonstrate the conformity of the product, in a language that can be easily understood by that authority
  • To inform the market surveillance authorities if there is a reason to believe that a product in question presents a risk
  • To cooperate with the market surveillance authorities
  • To make sure that the immediate, necessary, corrective action is taken to remedy any case of non-compliance, or to mitigate the risks presented by that product

The Regulation strictly lays out that the AR must have the appropriate means to be able to fulfill their tasks; therefore, it is important to have a professional AR, such as Obelis, with over 30 years of experience. Contact us today and make sure your products are in compliance with EU laws.

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Our team of lawyers, chemists, pharmacists, and other experts represents the largest centre in Europe for CE Marking and EC REP services.
Founded in 1988, Obelis is certified by ISO 9001:2015 and ISO 13485:2016, and partakes in various EU associations and EU commission working groups.
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