Role of the EU Authorized Representative (EC-REP)
Foreign manufacturers must appoint an EU Authorized Representative (AR) before they can sell their medical devices and IVDs in Europe.
The EU AR acts as the manufacturer’s regulatory representative in the European Single Market and is the point of contact between the manufacturer and the European national Competent Authorities.
The EU AR is also referred to as an EAR, EC Representative, EC Rep or Authorised Representative.
The MDR/IVDR increased the responsibilities of the EU AR. One significant change is that the AR now explicitly shares liability with the manufacturer for products on the market. Due to the significance of the AR role, it is important to choose a European Authorized Representative that is committed to acting as your partner in the market.
What are the responsibilities of the EU AR?
In addition to acting as a liaison with the European national Competent Authorities, the EU AR is responsible for the items below.
Verify that the manufacturer’s technical documentation is drawn up in accordance with the corresponding conformity procedure and maintain a copy of the technical file and CE certificate for each device it represents.
Verify that the manufacturer’s EU declaration of conformity aligns with the correct conformity assessment procedure.
Verify that the manufacturer complies with Unique Device Identifier (UDI) registration per Article 27 of the MDR, if applicable.
Provide authorization to include EU AR’s name and address on manufacturer’s labeling and any other relevant documentation.
Execute agreement (mandate) with the manufacturer to detail obligations of both manufacturer and AR throughout lifetime of the product in the EU market.
During Product Lifetime
Review and verify your EUDAMED Single Registration Number (SRN) application. The Competent Authority will perform the final review and issue the SRN.
Maintain a copy of the technical documentation and CE certificate. For non-implantable devices, the EU AR must maintain technical documentation for 10 years from the date the device is placed on the market. For implantable devices, the AR must maintain the documentation for 15 years.
Provide a current copy of your Technical File or EU Declaration of Conformity to Competent Authorities, upon request.
Inform manufacturer of any complaints from healthcare professionals, users and patients, and be available to support Incident and Field Safety Corrective Action (FSCA) reporting, in cooperation with you and your importers / distributors.
Casus Consulting can provide additional support for the following:
Provide general EU regulatory and medical device consulting, including support with registration in the European Database on Medical Devices (EUDAMED), confirmation of language/translation requirements and more.
Request Certificates of Free Sale (CFS) to facilitate registration and export in other global markets.
Assist with requisite medical device and IVD registration steps required by some EU member states.
Share updates regarding major regulatory changes which might impact a manufacturer’s devices and/or registrations.
What are the device labeling requirements?
Under the MDR and IVDR, the name and address of the Authorized Representative (AR) must appear on the device label. It is not required to place the AR information on the Instructions for Use (IFU), though we recommended to do so.
In order to minimize translations, the AR information should appear next to the EC REP symbol, as designated in EN ISO 15223-1:2016. If the device label is too small to include the EU AR information, it can instead appear on the packaging for each unit, and/or on the packaging of multiple devices.
For ‘legacy’ devices on the market under the old Directives (MDD, AIMDD, IVDD), the AR information can appear on either the product label, outer packaging or IFU.
Is it possible to transfer to a new Authorized Representative?
Yes, per Article 12 of the MDR and IVDR, it is possible to transfer your EU representative. However, there are several factors to consider when transferring this role:
Manufacturers will need to update their labeling to include the new AR information.
Manufacturers will need to confirm the end date of the relationship with their previous AR, and the start date for their new AR – their documentation should be updated to reflect the new AR in accordance with these dates.
Manufacturers must ensure their previous AR will send the manufacturer or new AR any complaints received from healthcare professionals, users or patients related to any devices placed on the market prior to the AR transfer date.
Where practical, the above should be defined in an Agreement signed by all three parties.
To avoid the additional costs and lost time associated with the transfer process, manufacturers should select an AR provider that will best partner with them throughout their commercialization journey in Europe.
Does my EC-REP also represent me in the United Kingdom and Switzerland?
The United Kingdom withdrew from the European Union. Therefore, manufacturers must now appoint a separate UK Responsible Person to market in the UK.
The Mutual Recognition Agreement between Switzerland and the European Union lapsed for medical devices and IVDs. Therefore, manufacturers must now appoint a Swiss Authorized Representative (CH-REP) to market in Switzerland.
While a single provider can act as your EU Authorized Representative, UK Responsible Person and Swiss Authorized Representative, that provider must have a physical location and registered business in each region. Casus can support our clients in all three markets, which helps streamline the process.