Regulatory Services
Comprehensive Support for Market Access and Compliance
Navigating the complex regulatory landscape of the European Union and the United Kingdom requires expert guidance and trusted representation.
At EUCEREP, we provide a full suite of regulatory services designed to ensure your medical products and devices meet all legal requirements, enabling smooth and compliant market entry.
Medical Device / In Vitro Diagnostic Devices
EU Authorized Representative
Manufacturers outside the EU must appoint a European Authorized Representative (EAR) to legally market their products within the EU. EUCEREP acts as your EAR, ensuring compliance with regulations such as the Market Surveillance Regulation (EU) 2019/1020 and the Medical Device Regulation (MDR). We handle product registration, technical documentation oversight, and act as the official liaison with EU authorities.
UK Responsible
Person
To sell medical devices and in vitro diagnostics (IVDs) in Great Britain, foreign manufacturers must appoint a UK Responsible Person (UKRP). EUCEREP serves as your UKRP, managing product registration with the MHRA, maintaining compliance with UK regulations, and facilitating post-market surveillance and reporting.
Free Sale Certificate / Export Declaration
When exporting regulated products outside the EU/EEA, an official Free Sale Certificate (FSC) or Export Declaration is often required. EUCEREP can obtain FSCs from both EU and UK authorities, certifying that your products are legally sold and approved in their country of origin, supporting your international market access.
EUDAMED
Registration
EUDAMED is the European Commission’s central database for medical devices, enhancing transparency and regulatory coordination. EUCEREP validates and manages your manufacturer information and device registrations in EUDAMED, ensuring compliance with EU Medical Device Regulations.
MHRA UK
Registration
EUCEREP registers all your medical devices and IVDs in the MHRA’s Device Online Registration System (DORS), fulfilling UK regulatory obligations and maintaining up-to-date product information for ongoing market authorization.
EPREL - European Product Registry for Energy Labelling
Register energy-labelled products
Create and manage the EPREL product entries on behalf of the manufacturer. This includes uploading the product information sheet, label files, and technical data, and managing versions.
Open and administer the supplier account in EPREL
Make sure the energy label and product information sheet match the data declared in EPREL and are provided to dealers (retailers).
What You Must Have in Place
We must have a written agreement from the non-EU manufacturer designating you as their authorized representative and supplier for EPREL.
Compliance with data obligations
Data in EPREL must be truthful, complete, and up-to-date.
We are responsible for ensuring label versions and technical files are correctly stored and accessible.
