An Importer is generally an EU-based entity that places medical devices or IVD products from outside the European Union onto the EU market under the applicable European regulatory framework.

Depending on the applicable regulations, importers may have responsibilities relating to compliance verification, documentation, traceability, and post-market activities.

Depending on the applicable supply chain structure and regulatory framework, products manufactured outside the European Union may require an EU-based Importer or other applicable economic operator arrangement before being placed on the EU market.

Importers may have responsibilities relating to compliance verification, traceability, documentation, and post-market activities under the applicable European regulatory framework.

The EU Authorized Representative and the Importer serve different functions under applicable European medical device and IVD regulations.

The EU Authorized Representative generally supports regulatory representation and communication activities on behalf of a non-EU manufacturer, while the Importer generally acts as the EU-based economic operator responsible for placing products from outside the EU onto the European market.

Depending on the applicable regulatory and supply chain arrangement, the two roles may be handled separately or coordinated through the same organization where appropriate.

Depending on the applicable regulatory and supply chain arrangement, a distributor may also act as the Importer where they are responsible for placing products from outside the EU onto the European market.

Manufacturers may wish to assess the commercial and operational considerations of combining these functions within the same entity.

Depending on the applicable European medical device or IVD regulatory framework, Importers may have responsibilities relating to compliance verification, labeling and traceability checks, documentation coordination, complaint handling, and cooperation with competent authorities.

Importers may also support applicable vigilance and post-market communication activities where relevant.

Importers are required to complete applicable EUDAMED-related registration activities before products are placed on the European market.

Applicable registration requirements may vary depending on the relevant regulatory framework and implementation status.

Applicable European medical device and IVD regulations may require Importers to maintain certain regulatory, traceability, complaint-handling, and post-market records for specified retention periods up to 15 years after products are placed on the market.

The applicable retention requirements may vary depending on the product category and regulatory framework involved.

Elpisia Europe may support multiple regulatory and economic operator functions relating to products entering the European market.

Appropriate operational processes are generally maintained to support applicable compliance and regulatory coordination activities.

Applicable European IVD regulations may include importer-related responsibilities for IVD products placed on the European market from outside the EU.

These responsibilities may include activities relating to compliance verification, documentation coordination, traceability, and applicable post-market processes.