Steps to sell in the EU
An Authorized Representative guidance
AF Pharma are the best partner for medical device manufacturers seeking comprehensive regulatory solutions. Our team of regulatory professionals offers services such as Technical File compilation, Clinical Evaluation Report (CER) generation, and Quality Management System (QMS) development. With expertise in international medical device regulations and standards, including ISO 13485 and EU MDR, AF Pharma, as Authorized Representative provide guidance to manufacturers through the regulatory landscape. We also provide meticulous support in compiling medical device Technical Files, producing comprehensive CERs based on thorough evaluations of clinical data, and developing customized QMS solutions, to follow the best steps to sell in the EU market.
Obtain the CE mark
Manufacturers need to obtain CE marking for all medical devices and IVDs before the products can be sold in the EU. This process includes generating a technical documentation file (TDF) and quality management system (QMS) based on the requirements of the MDR/IVDR. Once the evaluation has been carried out, the result will be a Declaration of Conformity. Your Authorized Representative shall help you.
Check here the information needed in the Technical File
Appoint EU Authorized Representative (EC-REP)
Non EU-Manufacturers must appoint an EU Authorised Representative (AR). Under the MDR and IVDR, the EU AR shares liability with the manufacturer for the product on the market and therefore plays a critical role.
The EU Authorized Representative information must be part of the device label and Declaration of Conformity.
Register Company and Devices
Your company and medical devices must be registered in the EUDAMED database and in the local Health Authority. The registration must be done by the EU Authorized Representative.
Appoint an Importer
For selling your devices in the EU, it is mandatory to have an importer when you are not a EU-manufacturer.
Importers shall be identified in the medical devices documentation and in the Device Registration.
Your EU Authorized Representative must guide you on how to obtain the correct importer.
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.