Spain Authorized Representative

A manufacturer without a registered office in a Member State must designate a sole authorized representative in the European Union for their product. This representative must keep the declaration of conformity, documentation, decisions, reports, and certificates of notified bodies for control purposes.

The manufacturer or their representative must keep these documents for five years from the date of manufacture, or 15 years for implantable products. This is in place for all products.

Manufacturers and their Authorized Representatives must

1. Ensure compliance with health authorities’ requirements by providing necessary product information in Spanish. However, supporting documentation in other easily understandable languages may be accepted. Failure to provide this documentation may be deemed non-compliance. If the importer or distributor lacks the required documentation, they must obtain it from the manufacturer or authorized representative.
2. Immediately rectify any infringements outlined by health authorities, such as absence of the CE marking or improper placement, in accordance with this royal decree. This includes addressing cases of non-compliance.
3. Cover expenses related to verifying product non-compliance, including evaluations or tests on the product or its technical documentation. Provide necessary samples for verification purposes.
4. Take necessary actions to restrict market placement, distribution, or service provision of products, including recalls, user recoveries, or other measures determined by health authorities in cases of suspected or proven health risks. Cooperate with authorities in implementing these measures.
5. Provide information, upon request, to health authorities regarding product suppliers, recipients, and relevant health centers. Maintain this information for a period of five years from the date of manufacture or supply, extending to fifteen years for implantable products.