Why do Manufacturers require a European Authorised Representative?
Legal background
Regulation 2019/1020 requires international manufacturers of medical devices (MDs) and in-vitro diagnostic devices (IVDs) who market their products in the EU to appoint a EU-based Authorised Representative. The purpose of this appointment is to ensure product compliance and to provide a point of contact for authorities.
The risks of non-compliance
What's at stake without an EU Authorised Representative
Market access blocked
Products may be barred from entering or remaining on the EU market.
Substantial fines
Regulatory authorities may impose significant financial penalties.
Confiscation and recalls
Non-compliant devices risk being confiscated or subject to product recalls.
Reputational damage
Public non-compliance notices may be issued, damaging brand reputation and eroding consumer trust.
Our services
The Solutions we offer as your EU Authorised Representative
Ensuring full regulatory compliance is not just a legal obligation, it’s essential to establishing your business and reputation in the European market. Partner with us to allocate an official point of contact for EU authorities who keeps all your technical documentation organised and inspection-ready. From guiding you through the CE marking process to verifying your device labels meet strict EU standards, we help streamline your path to market access. Our team also registers your products in the mandatory EUDAMED database, monitors post-market performance, and manages safety incident reporting and notifications, all so you can operate with confidence and peace of mind in the European market.
1
Step 1
Initial assessment
We review your products and documentation to determine exactly which EU requirements apply to you.
2
Step 2
Formal appointment
We are appointed as your Authorised Representative and take on the legal responsibilities on your behalf.
3
Step 3
Registration and labelling
We handle authority registrations and ensure your product labelling meets every EU requirement.
4
Step 4
Ongoing representation
We remain your point of contact for authorities, monitor regulatory changes, and keep you compliant year after year.
Frequently Asked Questions
A Responsible Person (RP) is a legal entity or individual established in the EU who ensures that cosmetic products comply with all EU Cosmetics Regulation requirements before being placed on the EU and EEA markets. The RP manages regulatory obligations such as product safety, labelling, notifications, and communication with authorities.
If you are based outside of the European Union, without an appointed Responsible Person based in the EU, your cosmetic products cannot be legally sold in the EU or EEA. This may result in import bans, product recalls, regulatory fines, and damage to your brand reputation, as well as limited market access and distribution challenges.
Appointing Obelis provides expert regulatory support, including formula reviews, compiling the Product Information File (PIF) assessment, safety test coordination, label compliance checks, and mandatory CPNP notification. We manage regulatory communications and keep you updated on evolving EU cosmetic regulations, ensuring smooth market access and ongoing compliance.
Getting started is easy: contact Obelis to discuss your products and regulatory needs. We will guide you through appointing us as your Responsible Person, review your documentation, and set up all necessary compliance measures to ensure your cosmetic products meet EU legal requirements.