Certification Company – Your reliable EU Authorised Representative
An EU Authorised Representative (or EU Responsible Person) is a natural or legal person who acts on behalf of the manufacturer in relation to the CE legislation:
- keeps all technical documentation available for inspection,
- takes care of any incident reporting,
- ensures compliance with constant regulatory updates and so on.
On the 16th of July 2021 a new Regulation 2019/1020 came into force that made mandatory for non-EU manufacturers to appoint an EU Authorised Representative (or EU Responsible Person) to be able to sell CE-marked products in the European Union. Please be aware that this Regulation is not only related to offline sales, but also to online. Certification Company have assisted many manufacturers in fulfilling their EU Authorised Representative needs and to have collaborations with well-known e-commerce platforms like Amazon SPN, ebay and bol.com.
Do you buy products outside the EU to resell it afterwards in the EU? Then you will be seen as an importer with all the related obligations. So, an appointing of the EU Authorised Representative may be beneficial to the importer as well (eventhough he is located in the EU) to have less liabilities to the European Commission, Authorities and Notified Bodies.
Product groups for EU Authorised Representative services
The product range for EU Authorised Representative services is huge from toys to complex machinery and installations and is related to the existing Directives and Regulations (Art. 4, section 5 Regulation 2019/1020). The simpliest way to check your product is to find whether the product bares CE-marking. If the CE-marking is affixed, send us the Declaration of Conformity and we will assist you in the further steps. Are you an importer? Did you find the CE-marking affixed, but you do not have the Declaration of Conformity? Contact us to get more information, where and how to request it.
PRRC for Medical Devices
Based on Article 15 of the MDR 2017/745 every medical devices manufacturer have to employ its own PRRC (Person Responsible for Regulatory Compliance). The exception is micro and small enterprises (with a turnover of less than 10 million or fewer than 50 employees) who may hire an external PRRC. This PRRC must be permanently and continiously available to the manufacturer.
The PRRC monitors compliance with the MDR 2017/745 within the organisation. A PRRC must therefore have knowledge of and experience with the regulations in the context of medical devices and the implementation and management of QMS (Quality Management System).
The duties of a PRRC include:
- to check the conformity of the devices, in accordance with the QMS
- to supervise the preparation and periodic checking of the Technical Documentation
- to ensure compliance with post-market surveillance obligations
- to supervise the obligations related to reporting incidents
Certification Company obtained the PRRC certification in 2021. This allows manufacturers to designate Certification Company as PRRC. Contact us directly to enquire further about PRRC services.
EU Authorised Representative services
Certification Company can be formally designated as the European Authorised Representative, responsible for your product(s) on your behalf. With a great deal of skills and expertise regarding European (CE) legislation at their disposal, our regulatory compliance experts are capable to take on part of your responsibilities, allowing you to focus more on the core tasks.
With Certification Company as your EU Authorised Representative, you will be offered the following services:
- Verification of the EU Declaration of Conformity and Techical Files;
- Keeping your compliance documents for 10 years;
- Providing the legal use of an EU-based address;
- Communicate with the EU authorities on behalf of your company;
- Performing an annual compliance review on the used harmonisation legislation and standards mentioned on the EU Declaration of Conformity;
- Handle the product recall process if needed.
Within 5 working days we become your Authorised Representative in EU. Contact us directly to discuss your project.
The process of getting EU Authorised Representative
In order to become designated as your Authorised Representative, we are required to verify that your EU declaration of conformity and Technical Documentation (also known as a Technical File) have been drawn up (phase 1). Once compliance with phase 1 has been established, the designation will be confirmed by a written mandate (EAR contract) and you will obtain a license (right) to use our logo and contact details (phase 2).