Full adherence to all compliance-related matters is a hugely important part of introducing a product to the European Market – or indeed maintaining its position there. Each category of CE Marking certifiable product has its own set of regulations or directives, from medical devices to personal protective equipment to toys, and electromagnetic devices to construction products and motor vehicles.
The onus is entirely on the manufacturer to demonstrate that their product is in full compliance with the relevant essential EU directives and regulations – all of which must be adhered to in advance of a CE marking being initially affixed. Some directives also call for the appointment of a Notified Body to assess compliance or product-specific issues, though this is generally only the case with high risk or safety critical products.
For products found not to be in full compliance with applicable directives and regulations, there can be a range of consequences. Consequences can involve, but are not limited to:
- Removal of the product from the EU market temporarily
- Removal of the product from the EU market permanently
- Refusal of free movement of the product within the EU zone
- Cause for restarting the compliance process
- Loss of the product’s CE marking
- Recall of the product from end users
- Ban on the marketing of the product
- Destruction of the product
The severity of the consequences can vary according to the scale of the compliance infringement and the category of the product in question. In cases where a manufacturer/distributor is located outside of Europe, all compliance information for each product must be held by an Authorized Representative with a registered address inside the European Union. As the main point-of-contact for the manufacturer/distributor, the Authorized Representative is responsible for the notification process, incident reporting, safeguarding of compliance, and representation towards European commissions, authorities, and notified bodies, as well as consulting on European regulations.
To find out more about the compliance process for a wide range of product categories, receive a free quote on Obelis’ Authorized Representative services, or for advice on CE marking in general, contact our team of regulatory experts today!