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
The EU requirements concerning the marketing of products — from toys to construction products and electrical equipment — aim to ensure users’ safety. Ensuring compliance is an ongoing process, which includes post-market surveillance activities. Thus, the manufacturer shall continue collecting information related to the use of its products after they have been marketed.
Regarding Post-Market Surveillance, the manufacturer shall:
- Keep the technical documentation, declaration of conformity and where relevant notified body certificate for 10 years after it has placed the product on the market;
- Maintain the technical documentation up to date to reflect the modifications to the product;
- Ensure traceability of products placed on the market;
- Implement procedures for series production to remain in conformity that take into account the changes in the product’s design or characteristics, and updates to harmonised standards and technical specifications;
- Stay updated on new requirements and legislative changes;
- Cooperate with competent national authorities (CA) in case dangerous or non-compliant products are placed on the market;
- Provide on request CA with all information necessary to demonstrate the conformity of a product;
- Bring non-compliant products into conformity;
- Take corrective measures if non-conformities arise — such as the recall of irregular batches;
- Report promptly to the CA of Member States in which products are made available in situations of risk to health, safety, the environment or any other public interest protected by the applicable legislation. For GPSD products via the European Commission Product Safety Business Alert Gateway;
- Record complaints, non-conformities and recalls;
- Carry out sample testing of marketed products, when necessary;
- Inform distributors, importers and the Authorised Representative about monitoring activities.
If you appoint Obelis as your Authorised Representative (AR) in the European Union, our experts will help you to ensure that you take the necessary Post-Market Surveillance activities.
Contact us for the details of Post-Market Surveillance activities related to your products.
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.
