A blog about what a European Authorized Representative is and how you can choose one.
In this blog we will look at the representation system in the European Union and explain how it works. We'll explain what a European Authorized Representative is, tell you how its role is defined, and what you can expect from them.
A European Authorized Representative is a legal requirement for non-EU medical device manufacturers.
A European Authorized Representative (EAR) is a legal requirement for non-EU medical device manufacturers. This role has to be filled by a person, called the responsible representative, who will act on behalf of the manufacturer and with their power.
The EAR is responsible for ensuring that all documentation submitted to the competent authority satisfies all regulatory requirements, including technical documentation and registration forms. The EAR also has to ensure that any changes made to products are reported to the competent authority as soon as possible.
As an EAR, you must be able to demonstrate that you have sufficient knowledge of the European legislation that applies to your products. You will also need to know how these regulations apply in practice, so it is important to have a good understanding of how they work in practice too.
The European Authorized representative must be established in the EU.
The European Authorized representative is a person or a company that is established in the EU and has the legal authority to represent a foreign company.
The European representative must be established in the EU. In other words, they cannot be located in another country outside of Europe.
In addition to being established in the EU, the representative must be subject to the laws of that country as well as those of their own country.
The most common types of European authorized representatives include:
- An individual who acts as an authorized representative on behalf of a foreign company (an individual). This includes employees of foreign companies who are appointed as European Representatives.
- An agency established by law or by government regulation which represents multiple foreign companies (an agency).
The European Authorized Representative must be accessible to regulatory authorities at all times and act on the manufacturer’s behalf.
The European Authorized Representative must be accessible to regulatory authorities at all times and act on the manufacturer’s behalf.
The European Authorized Representative is a legal entity that has been recognized by a Member State to represent a company in relation to EU-wide approval procedures. The European Authorized Representative must be accessible to regulatory authorities at all times and act on the manufacturer’s behalf. The European Authorized Representative can be any type of entity: an individual, a company or an association. It is important to check if there are any restrictions on who can become a European Authorized Representative for your product.
The European Authorized Representative will receive requests from the CE marking authorities for information about your product and will respond accordingly. This means that you should provide them with all relevant information about your product, including copies of certificates and documents related to it. You should also inform them about any changes in this information so that they can update their records accordingly.
The European Authorized Representative is required to forward product recalls and vigilance reports to the manufacturer and supervise the implementation of corrective actions.
The European Authorized Representative (EAR) is the representative of a foreign manufacturer or importer in the EU, who is required to forward product recalls and vigilance reports to the manufacturer and supervise the implementation of corrective actions.
The EAR is also responsible for ensuring that all necessary information about a product or batch is forwarded to relevant authorities e.g. in case of a suspected or detected safety risk or quality issue. US FDA Certificate The EAR is also responsible for providing documentation on the use and maintenance of the product e.g. manuals, instructions for use, technical documentation etc., as well as any other documentation related to safety, health and environmental protection aspects of the product at hand.
A key function of an EAR is therefore to provide technical assistance during market surveillance activities by competent authorities.
The requirement to appoint an EAR was introduced through Regulation 1025/2009 (recast), which entered into force on 1 July 2011 and extended the scope of application of European legislation on consumer protection applicable within the EU market from consumer products only to all products placed on the market irrespective of whether they were produced in the EU or imported from outside Europe.
Nowadays it seems that regulatory burden is increasing, and as a result it is becoming increasingly important to register your manufacturing facilities and appoint an Authorized Representative in the European Union. Doing this correctly can help you avoid being subject to penalties due to non-compliance
