Steps to sell in the EU
EU market access guidance
AF Pharma Service helps manufacturers, brands, distributors and online sellers understand what is required before placing their products on the EU market. Our team supports companies with EU Authorized Representative services for medical devices and IVDs, EU Responsible Person services for cosmetics, GPSR support for general consumer products, Amazon Responsible Person requirements, and EU compliance review for food supplements and nutraceuticals. We review product documentation, labels, claims, technical files, safety evidence and registration or notification requirements, helping companies prepare the correct compliance file and reduce delays before market launch.
Identify the EU Regulatory Pathway
Before selling in the EU, your product must be correctly classified.
AF Pharma Service reviews medical devices, IVDs, cosmetics, Amazon products, food supplements and general consumer products to confirm the applicable EU requirements.
Depending on the product, this may include CE marking, EU Authorized Representative, EU Responsible Person, CPNP notification, GPSR compliance, Amazon Responsible Person documentation, or label and claims review.
For Medical Devices: Check here the information needed in the Technical File
Prepare the EU Compliance Documentation
Once the correct regulatory pathway is confirmed, the next step is to prepare the documentation required to place the product on the EU market.
AF Pharma Service helps review and prepare compliance files for medical devices, IVDs, cosmetics, Amazon products, food supplements and general consumer products. Depending on the product, this may include technical documentation, Declaration of Conformity, risk assessment, label and IFU review, Product Information File, CPSR, CPNP notification, GPSR documentation, test reports, supplier evidence, or Amazon compliance files.
A complete and well-structured compliance file helps reduce regulatory delays, authority questions and rejected online listings.
Appoint the EU Representative or Responsible Person
AF Pharma Service can act as EU Authorized Representative / EC Rep for medical devices and IVDs, and provide EU Responsible Person, GPSR Responsible Person and Amazon Responsible Person support for other product categories.
We support medical devices, cosmetics, Amazon products, food supplements and general consumer products, helping companies meet EU representation, documentation and contact requirements before market launch.
Having the correct EU representative in place is essential for regulatory communication, market access and ongoing compliance.
Register, Notify and Place the Product on the EU Market
The final step is to complete the applicable EU registration, notification or compliance process before selling the product.
AF Pharma Service supports companies with medical device and IVD registration, EUDAMED and national registration support where applicable, CPNP notification for cosmetics, Amazon compliance submissions, GPSR documentation, and food supplement notification support where required.
We also review labels, claims, warnings, instructions for use and product documentation to help ensure the product is ready for the EU market.
Once the required documentation, representative appointment and registration or notification steps are completed, your product can be placed on the EU market with greater confidence.
We
understand you
When it comes to successfully entering the European Union (EU) market with your medical device, AF Pharma stands out as the best partner to rely on. With our unparalleled expertise in Technical Documents, Quality Management Systems (QMS), and Registrations, AF Pharma offers comprehensive solutions tailored to meet the stringent EU medical device regulations. Our team of knowledgeable professionals possesses a deep understanding of the intricacies involved in preparing the necessary Technical Documents, ensuring compliance with EU requirements. Additionally, AF Pharma's proficiency in developing robust QMS enables manufacturers to establish a solid foundation for maintaining medical device regulatory compliance throughout the product lifecycle. With their extensive experience in EU Registrations, AF Pharma guides you seamlessly through the complex regulatory landscape, ensuring a smooth and successful market entry for your medical device.
Trust AF Pharma to be your trusted partner in achieving medical device regulatory success and unlocking the vast potential of the EU market.