EU Product Compliance Services

Manufacturers, importers, distributors, and other businesses entering or operating in the European Union must meet regulatory requirements that vary by product type, applicable EU legislation, destination member state, and the business’s role in the supply chain. Medical devices, food supplements, and cosmetics each have different requirements for documentation, labeling, registration, notification, and ongoing compliance.

Before beginning a registration or notification, businesses should establish the applicable regulatory pathway, identify the responsible parties, and determine any ongoing maintenance requirements. This helps distinguish EU-wide requirements from member-state requirements and determine whether an EU-based authorized representative, Responsible Person, importer, or other local party is required.

EU Medical Device Registration & UDI

Manufacturers placing medical devices on the EU market must comply with the applicable requirements under the Medical Device Regulation (MDR) or In Vitro Diagnostic Medical Device Regulation (IVDR). Depending on the device and manufacturer, requirements may include device identification, UDI, labeling, technical documentation, conformity assessment, and registration in the European Database on Medical Devices (EUDAMED).

A manufacturer established outside the EU must appoint an EU-based authorized representative. The manufacturer remains responsible for its devices and the information it submits, while the authorized representative has separate responsibilities under EU law. EUDAMED registration does not replace conformity assessment or provide CE marking.

EUDAMED Registration Requirements & Process

The process begins by confirming the manufacturer’s and authorized representative’s applicable EUDAMED actor information and access. The manufacturer then prepares the required device and Unique Device Identification (UDI) information, including Basic UDI-DI and applicable device identifiers.

EUDAMED support may involve reviewing source records, checking consistency between device, certificate, label, and UDI information, preparing required registration data, entering information into the applicable EUDAMED modules, and addressing registration issues. The EUDAMED Actor Registration and UDI/Device Registration modules became mandatory to use on May 28, 2026, subject to applicable transition provisions.

EUDAMED Updates & Fees

Manufacturers must maintain accurate actor and device information and update applicable records when relevant details change. Costs associated with EU medical device compliance can include UDI assignment, conformity assessment, authorized representative services, and other regulatory activities. No single EU application or annual fee covers every medical device registration or compliance activity.

FDA Listing Inc. can review actor and device information, prepare UDI data, identify labeling and documentation gaps, and support EUDAMED data entry through appropriately authorized portal access, where permitted. We do not act as the EU authorized representative or provide CE certification. Contact us to discuss the device, its existing EU representative, and the registration or data-management work required.

EU Food Supplement Compliance

Food supplements placed on the EU market must meet applicable requirements for ingredients, labeling, and nutrition or health claims. Individual EU member states may also apply national requirements, including restrictions on certain ingredients or notification requirements before placing a product on the market. A notification in one member state does not constitute a single EU-wide supplement registration.

The food business operator responsible for placing the product on the market must determine the requirements applicable in each destination country. Products containing certain ingredients, making medicinal claims, or raising novel-food or other classification issues may require additional assessment before they can be marketed as food supplements.

Supplement Requirements & Notification Process

The process begins with identifying the destination country and reviewing the product formula, ingredients, intended use, claims, and proposed label. Where notification is required, the responsible business prepares the applicable product information and label, submits the notification to the relevant national authority, and addresses any follow-up questions.

Requirements can differ between member states, so additional countries may require separate assessments or notifications. We define the specific country and product scope before beginning the project rather than treating EU supplement compliance as a single filing.

National Fees & Ongoing Requirements

Notification procedures and fees vary by member state. Some countries may not require notification for a particular product, while others may require a notification, charge a fee, or require updates when product information changes. Applicable costs and ongoing obligations must therefore be confirmed for the specific destination country.

FDA Listing Inc. can review supplement ingredients, claims, and labels, identify documentation gaps, and prepare or support a notification for an agreed member state. We assess products involving novel-food, medicinal-classification, or other complex regulatory questions individually. Contact us with the proposed formula, label, and destination country.

EU Cosmetic Product Notification (CPNP)

A cosmetic product placed on the EU market must have an EU-established Responsible Person. The Responsible Person must ensure the product meets applicable EU cosmetic requirements, including maintaining the required safety assessment, Product Information File (PIF), labeling, and Cosmetic Products Notification Portal (CPNP) notification.

CPNP notification is not an EU product approval. The Responsible Person must have the required product information and supporting documentation in place and complete the notification before placing the cosmetic product on the EU market.

CPNP Notification Requirements & Process

The process begins with a review of the product details and supporting documentation, including the cosmetic safety assessment and PIF. The team then prepares and checks required product, formulation, contact, and label information for consistency before submitting it through CPNP using appropriately authorized portal access.

Certain products, including some products containing nanomaterials, may have additional notification requirements. The Responsible Person remains responsible for maintaining the product information and CPNP record and ensuring that applicable regulatory requirements continue to be met.

CPNP Updates & Fees

The Responsible Person must keep product information current and update the CPNP notification when relevant details change. The CPNP notification itself generally does not carry an EU filing fee, but businesses may incur separate costs for cosmetic safety assessments, PIF preparation, testing, and Responsible Person services.

FDA Listing Inc. can review cosmetic ingredient and label information, assess PIF completeness, prepare CPNP notification data, and support CPNP entries or updates through appropriately authorized portal access, where permitted. We do not act as the Responsible Person or sign the cosmetic safety assessment. Contact us to discuss the product, available documentation, and proposed notification scope.

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Frequently Asked Questions (FAQ)

Does EUDAMED registration mean a medical device is approved for sale in the EU?

No. EUDAMED registration does not replace the applicable conformity assessment or grant CE marking. Manufacturers must meet the applicable medical device requirements before placing a device on the EU market.

Does a manufacturer outside the EU need an authorized representative for a medical device?

Yes. A manufacturer established outside the EU must appoint an EU-based authorized representative for devices placed on the EU market. The manufacturer and authorized representative have distinct responsibilities, and appointing an authorized representative does not transfer the manufacturer’s obligations.

Do all EU countries use the same food supplement notification process?

No. EU Member States may have their own notification procedures and additional national requirements. A notification submitted in one country does not automatically cover other Member States. Requirements should be reviewed for each country where the supplement will be marketed.

Does a cosmetic product need an EU Responsible Person?

Yes. A cosmetic product must have a Responsible Person established in the EU before it is placed on the EU market. The Responsible Person ensures compliance, including required safety and product documentation, labeling, and CPNP notification.

Is a CPNP notification an approval of a cosmetic product?

No. CPNP is a notification system, not a product approval process. The Responsible Person must ensure the cosmetic meets applicable requirements and complete the notification before placing the product on the EU market.

Can FDA Listing Inc. assist if we already have an EU authorized representative or Responsible Person?

Yes. We can review product information, labels, and supporting documents; identify compliance gaps; prepare registration or notification data; and support portal entries or updates through appropriately authorized access, where permitted. We do not act as the EU authorized representative or cosmetic Responsible Person.