General Products

Among the new requirements, non-EU manufacturers will have the obligation to have an economic operator based in the European Union, such as the authorised representative. The GPSR aims at increasing the safeguard of consumers’ safety and improve market surveillance activities. To reach this aim having a contact point in the EU is crucial. This applies to both offline and online sellers.

Non-EU manufacturers can appoint an authorised representative under the current Directive and future Regulation. Among the main tasks under the GPSD, the authorised representative keeps the manufacturer’s documentation available to national surveillance authorities and cooperates with competent authorities to eliminate any risks the products might represent.

The key requirement to place GPSD products on the EU market is having a technical documentation compliant with all applicable regulatory requirements. The main elements of the technical documentation are technical file, quality manual, compliant labels and IFUs, tests, Declaration of Conformity, and other declarations. Based on the characteristics of the products, other documents might be mandatory.

The manufacturer is responsible to continue to collect information related to use of their products after they have been made available to consumers. Moreover, GPSD manufacturers must ensure that their products continue to be compliant as the legislation applicable to their products evolves. Post-Marketing surveillance activities include, but are not limited to:

• Staying up to date on new requirements or legislative changes
• Continual updating of the technical file as modifications are made to the product
• Reporting of any incidents related to the product use
• Removal of non-compliant batches from EU economics operators and end-user
• Keeping technical file available for 10 years after the last batch entered the EU market

Working with a professional authorised representative will help to ensure that the necessary actions are taken to ensure continued compliance and proper post-market surveillance.

In the case that a product is found to be non-complaint, the main consequences include, among others:

• Being publicly reported to Safety Gate
• Warehousing Fees
• Requested Withdrawal
• Mandated Withdrawal
• Product Recall (from end-users and/or the market)
• Complete ban on marketing of the product
• Destruction of the product
• Fines
• Revocation of the CE Marking

The professionalism and expertise of the appointed authorised representative in dealing with various competent authorities and handling post-market surveillance cases play a vital role in the successful recovery of your brand in the EU Market.