Product Registration
What is Product Registration?
Regulatory compliance refers to the process by which a business or individual meets the legal requirements set out in applicable legislation, regulations, and standards governing their products, operations, or data practices. In the context of EU and UK product regulation, regulatory compliance encompasses all the obligations a manufacturer, importer, distributor, or other economic operator must fulfil to lawfully place products on the market and keep them there.
Why It Matters
Product registration ensures that regulatory authorities have accurate and accessible information about the products available on the market, the economic operators responsible for them, and the compliance evidence supporting their safety and conformity. For many regulated product categories, registration is not simply a formality — it is a legal prerequisite for market access.
Placing a product on the market without completing required registration can result in the product being considered non-compliant, removed from sale, or subject to enforcement action. For online marketplace sellers, unregistered products may also be removed from platform listings where marketplaces are required to verify compliance under applicable legislation.
For manufacturers, importers, and ecommerce sellers across regulated product categories, completing product registration accurately and on time is a fundamental step in achieving and maintaining lawful market access.
Key Requirements
When Is Product Registration Required?
Product registration requirements vary by product category and applicable legislation. Registration is required under several EU and UK regulatory frameworks, including:
- EUDAMED — for medical devices and IVDs placed on the EU market under the EU MDR and IVDR
- Cosmetic Products Notification Portal (CPNP) — for cosmetic products placed on the EU market under the EU Cosmetics Regulation
- MHRA registration — for medical devices placed on the Great Britain market
- Other sector-specific registration systems under applicable EU and UK legislation
In each case, registration must be completed before the product is placed on the market, and registered information must be kept accurate and up to date throughout the product’s lifecycle.
Responsibilities Relating to Product Registration
While specific obligations depend on the product category and applicable legislation, responsibilities commonly include:
- Identifying all applicable registration requirements for the product and target market before placing it on the market
- Completing registration through the correct portal or with the correct authority prior to market access
- Ensuring the economic operator responsible for registration — such as the Responsible Person or EU Authorised Representative — is correctly identified in the registration
- Keeping registered information accurate and up to date, and notifying the relevant authority of any changes without undue delay
- Retaining evidence of registration as part of the product’s compliance documentation
- Repeating or updating registration where the product is significantly modified or where registration expires
Product Registration and the Authorised Representative
For non-EU manufacturers, product registration obligations are closely linked to the appointment of an EU Authorised Representative or Responsible Person. In many cases, the Authorised Representative or Responsible Person is required to be registered alongside the product, and their details must be linked to the product registration in the relevant system. For non-EU manufacturers, the Authorised Representative or Responsible Person often manages the registration process on their behalf.
Need compliance support for the EU and UK?
Euverify provides EU Authorised Representative, Responsible Person, and GDPR Article 27 Representative services for businesses placing products on the EU and UK markets. Our team supports regulatory communication, documentation, and ongoing compliance management across multiple frameworks.
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