EU Authorized Representation (EU AR)

EU Authorized Representative (EU AR) is a European established person or a company, legally required by non-European manufacturers to get access to the European market, as per MDR Act. This representative is authorized by manufacturers to not only act on their behalf, but to handle and verify their legal and technical documentation, connect them to National Competent Authorities, and ensure that the product's design and packaging comply with all required EU standards.

According to Article 11 of the EU MDR, no product can enter the boundaries of 27 members of European Union, if the manufacturer is located outside of EU and does not have a legal EU Authorized Representative. EU AR is considered as legal anchor by European authorities; it acts as official contact body between authorities and manufacturers and eliminates the need of direct factory visits by authorities. EU AR helps the customer to get CE mark, as customs do not validate product's entry without this mark on packaging. EU AR not just provides contact info for label, but also carries the legal obligation to meeting compliance standards, and acts as 24/7 open bridge of communication with European regulatory bodies.

Our company acts as EU AR for Class 1 medical devices. The medical devices of Class 1, such as surgical scissors, stethoscopes, bandages and needle holders, are considered as low risk, pose minimum risk by design, are non-invasive in nature (do not enter the body or have brief contact of less than 60 minutes with it), and are intended for use on patients. These devices do not demand third party audit due to the status of self-certified but need surety of 100% perfect technical files. To ensure smooth, safe, and quick business, without heavy fines and market bans, we will make sure your technical files are audit ready round the clock.

Article 11, MDR, clearly mentions the mandatory responsibilities of EU AR and must be added in official mandate:

Compliance Check: First and foremost, duty is to check and ensure that all technical documents are correct in terms of formatting and meet the checklist provided by EU authorities.

Records Management: Make sure immediate documents availability on authority call 24/7. For this reason, securely keep a hard and soft copy of all required technical files for 10 to 15 years.

Official Gateway: To ensure smooth business, provides a single official and legal window to entertain queries from concerned bodies in official languages and keeps client's interest as first priority during inspections.

Support Registration Process: Provide help in registration process and maintaining Single Registration Number (SRN) and your presence in European database (EUDAMED).

Incident and Surveillance: Instantly communicate and keep updated regarding any customer complaints. Also helps to coordinate product recall from market to ensure patient safety and to keep up brand's reputation, if needed.

Label Requirements: Ensure that label displays correct details of EU AR contact information, instructions for right way to use products and legal CE marking to prevent custom blockage.

Contract Management: Provide legal and formal mandate to prove legal rights for product selling in European market. Continuously monitor compliance requirements to make sure that market access is smooth and risk free.

1. Mandatory business details and a clear product catalogue (device type, model, classifications, and list of countries to import product).
2. Hard and soft copy of technical and safety documentation to perform initial compliance check.
3. Details of staff members included in designated team for handling official notices and to provide technical responses to queries from our office.
4. Required information for securing Single Registration Number and official registration in European database (EUDAMED).
5. Current label samples and instructions, to verify our details as Authorized Representative are presented correctly.

Swift Action: Always at front-line, act efficiently and promptly while addressing queries from authorities and customers. Our technical experts resolve regulatory requests in local languages and respective time zones, allowing smooth momentum.

Seamless Coordination: Through direct and clear communication questions are precisely answered, removing confusions, and saving time, keeping the approval process on track.

Quick Support: Our team handles requests not only with technical accuracy but also with high speed, ensuring no gap left in communication.

Q: What should the product label look like?
A: The label should have these three mandatory items: official company and product name, EU AR contact info (name and address), and CE mark. This helps the EU authorities and customers to identify product and your legal spokesperson easily and swiftly.

Q: What are the consequences of not having an EU AR?
A: Manufacturer can't apply for CE mark, mandatory mark for product's entry in European borders, without an EU AR. Products without CE mark might face permanent block or heavy custom fines.

Q: Do EU authorities conduct inspection on EU AR?
A: Yes, authorities can inspect the EU AR office and manufacturers' legal and technical files. Representatives have to make sure that products meet all compliance standards.

Q: Do multiple EU ARs are needed for different countries?
A: No, according to European union law, a manufacturer only requires one authorized representative regardless of number of devices and targeted countries of European union.

Q: Is my EU AR jointly and severally liable for my product?
A: Yes, under MDR, EU AR and manufacturer are legally responsible for defective devices. This shared responsibility ensures patient safety.

Q: Is it possible to change my EU AR after appointing one?
A: Yes, EU AR can be switched at any time by signing a tripartite agreement among manufacturer, existing EU AR, and new EU AR. By using this agreement, the responsibilities and documents shift efficiently and effectively between representatives.