Frequently asked questions about the European Authorized Representative (AR) under the Medical Device Regulations
To place a medical product on the European Market, all non-EU manufacturers must appoint an Authorized Representative (AR or EC Rep) within the Union. conforming to the new medical device regulations, the AR plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person within the Union.
Given its pivotal role, an AR is jointly and severally liable with the manufacturer for defective devices if the manufacturer has not complied with its general obligations.
The tasks and duties of an AR are defined in a written mandate by the manufacturer, including the legal requirement of having available a person who fulfills the minimum conditions of qualification similar to those for a manufacturer’s responsible person for regulatory compliance.
The manufacturer also has to ensure that the AR has the design documentation of the medical device permanently available.
The manufacturer and/or the AR may have to consult the expert panel or the competent authority while deciding whether the AR may be appointed for the products (expert panels consist of advisors appointed by the European Commission).
Why choose an independent AR?
- An AR is jointly and severely liable for defective devices. CEpartner4U is prepared to take on this responsibility;
- An AR permanently holds the design documentation. This documentation must be kept even in case the manufacturer ceases its business activity in the Union. CEpartner4U has a secured data server, compliant with ISO27001, and located in the Netherlands. Distributors should not be in the possession of such proprietary information;
- An AR must have a qualified person available to verify manufacturer’s regulatory compliance. CEpartner4U has over 20 years of experience in the regulatory field;
- An AR is obliged to inform the authorities about the economic operators in the field;
- An independent AR deals with regulatory affairs only and does not distribute or sell devices. If a (master) distributor fulfills the position of AR, commercial interests may interfere with device safety (e.g. warehouse conditions, information supply to customers, incident handling etc.). Furthermore, other distributors may be reluctant to deal devices with the name of that master distributor printed on the label (as AR).
How to select an AR?
Choose an independent, experienced AR who is well versed in both the medical device industry and regulatory compliance. CEpartner4U has sample agreements clearly outlining the essential duties of an AR.
CEpartner4U has been in business for over 20 years and is a member of the European Association of Authorized Representatives.
What are the manufacturer’s main duties?
- Guarantee device safety and performance;
- Provide the technical documentation to the AR;
- Print the AR’s name and address on the product label;
- Notify the AR of any incidents with the devices;
- Cooperate with the requests of Competent Authorities;
- Indemnify the AR from product liability;
- Provide periodic summary reports on the safety of the device;
- Comply with the requirements of a Unique Device Identifier (UDI) and the registration of devices;
- Appoint a person responsible for Regulatory Compliance.
What are the essential duties of the AR?
- Act on the manufacturer’s behalf in relation to specified obligations under the regulations;
- Cooperate with the requests of Competent Authorities;
- Verify if the manufacturer has drawn up the technical documentation and DoC;
- Verify if the appropriate conformity assessment procedure is followed by the manufacturer;
- Register the economic operators and verify if the manufacturer has complied with his UDI and registration obligations;
- Keep the technical documentation available to the Competent Authorities;
- Reporting vigilance cases;
- Have a qualified person available to verify manufacturer’s regulatory compliance;
- Ensure the confidentiality obligations.
What is the reason for placing part of the technical documents on file in the EU?
An AR must be able to provide all documentation and information that an authority may require.
Is the technical information confidential?
Confidentiality is secured through the AR-Agreement. The regulations require that all parties, Competent Authorities included, are bound to observe confidentiality regarding all documents and information.
- Over 20 years of experience in the medical industry, EU regulatory affairs, and quality management. Onboard qualified personnel;
- Independent but solid relationships with the EU Authorities and Notified Bodies;
- The manufacturer’s first line of defense in all EU regulatory affairs;
- Member of the European Association of Authorized Representatives, meaning ahead of developments and first-hand information from the commission;
- Ongoing monitoring of your compliance and assistance with eventual restrictions of selling on the European Market;
- Hundreds of satisfied customers from all over the world;
- Arrangement for Free Sales Certificates;
- The manufacturer’s documents, certificates and project related files are stored on a secure, ISO27001 certified data center located in the Netherlands, accessible only to personnel working on its project. The data is never stored on laptops, desktop computers or portable media;
- CEpartner4U provides for remote access and up- and download of large amounts of data;
- CEpartner4U holds in strict confidence and never discloses, furnishes, communicates or makes accessible to any person or use in any way for CEpartner4U’s own or another’s benefit any confidential information;
- Your authorized representative under the MDD/ IVDD/MDR/IVDR, for clinical trials, under the General Data Protection Regulation, and for the LVD, EMC and RoHS directives.