EU Authorized Representative (EC Rep / EAR) - EUDAMED Registered
EC Rep | EU AR | European Authorized Representative
What an Authorized Representative is?
A medical device European Authorized Representative (EAR) serves as a legal European Company to work on behalf of a foreign manufacturer. This EAR is designated by non European Union (EU) medical device manufacturers, to represent them in the EU and ensure their compliance with the European Regulations.
The Authorized Representative is the entity to which the authorities and institutions of the EU Member States may address the obligations set out in the legal requirements for medical devices. A medical device authorized representative may also carry out a conformity assessment of a medical device on behalf of the manufacturer.
Which the responsibilities are?
An medical device Authorized Representative holds the responsibility to act as a neutral party between the competent authorities and the non EU medical device manufacturers. They must ensure the medical device manufacturer is in compliance with the conformity assessment procedure set out in the European regulations which apply to the manufacture's product.
Who should report any vigilance problem?
The medical device Representative or EC Rep must uphold dual accountability with the medical device manufactures if problems or questions arise regarding the medical device. It also must provide their contact information for the medical device manufacturer to place on the products, allowing the EC Rep to be the primary contact for EU authorities.
What the Declaration of Conformity is?
In the same way, the CE certificate and the declaration of conformity of the medical devices can only be issued by a company located in the European Union, in this case the Authorized Rep.
What is a European Authorized Representative (EC Rep) for?
According to the MDR 2017/745, the medical device EU Authorized Representative (EC Rep) is any natural or legally established person in the European Community, who is explicitly designated by the medical device manufacturer to act on its behalf. This person/company may be consulted by Authorities and Bodies regarding the requirements of Directives / Regulations. The EUAR is responsible for the medical devices and foreign manufacturer in the EU.
What are the functions of an Authorized Representative?
The role of an Authorized Representative is varied and challenging. The main functions include, but are not limited to, the following:
Make the manufacturer and medical devices registrations
Provide a registered address within the European Union for the medical devices
Keep all technical documentation of the medical devices manufacturers available for inspection by the Authorities
Complete notifications to the Authorities regarding the medical devices
Complete any registration of medical devices in the national databases
Handle any incident reports from medical devices
Represent the medical device manufacturer before the European Commission, Authorities and Notified bodies
Safeguard and ensure compliance with constant regulatory updates for the medical devices
Consultancy in Medical Device European Regulations
AF Pharma Service is registered in the EUDAMED database as medical device EU Authorized Representative (EC Rep). We help our medical devices manufacturers to be part of EUDAMED making the medical device manufacturer and medical device registration in the European EUDAMED database.
We offer medical device EU authorized representative services, Regulatory and Quality consulting services and import solutions, along with regulatory consulting with our partners located around the world. Also, we are certified for Medical Devices under MDR 2017/745, for Invitro Diagnostics under IVDR 2017/746, as long as the old MDD, AIMD and IVDD certifications.
Do not miss our UKRP (UK-MHRA) services for medical devices too. We can provide you a better quote, choosing both services.
AF Pharma your Authorized Representative
AF Pharma Service, as an EU Authorized Representative, offers essential services, while concurrently assisting clients in formulating effective medical device regulatory strategies. Our expertise spans across various sectors including medical devices, in vitro diagnostics, cosmetics, nutraceuticals, machinery, and other health products. With our comprehensive medical device EAR services, we ensure that clients comprehend and fulfill the medical device regulatory obligations, facilitating their access to the EU market.
MACHINERY AUTHORIZED REPRESENTATIVE
The EU Authorized Representatives (also referred to as an EU Auth. Rep., EC Rep or AR) is a mandatory economic operator for every Non-EU medical device, machinery, cosmetics and other manufacturer. With the new MDR implemented, choosing the correct Medical Device Representative is the main task for any manufacturer.
We are register in the EU Health Authority from Spain and in EUDAMED database to act as Authorized Representatives for:
- medical devices
You can benefit of our full services in:
MDR (Medical Device Regulation EU 2017/745)
IVDR (InVitro Diagnostic Regulation EU 2017/746)
Authorized Representative services
EUDAMED database company and device registration
We can act as your UK Responsible Person (UKRP) for the MHRA , as well as EU Authorized Representative (EC Rep) for the European Union. Contact us for the best quote!
Quality & Regulatory
QUALITY AND REGULATORY CONSULTING
We develop a specific plan for each manufacturer of medical device, machinery, cosmetic and nutraceutical, in order to provide the most efficient Authorized Representative and Import services. By positioning ourselves in the market, we make our clients stand out and be competitive in a world of dynamic regulations. We design regulatory and fundraising strategies, in conjunction with representation and importation. However, we also adapt to customers and provide non-comprehensive services, such as the Authorized Representative service without importation, or only regulatory consulting.
We have the knowledge, smart tools, and global resources to understand the implications of the decisions our clients make. Contact us to find out how this service can benefit you.
We advise on ISO 13485, 14971 and EU MDR QMS (MDR Quality System Management)