Foreign manufacturers must appoint a European Authorized Representative (EU 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 new EU medical device regulations (MDR/IVDR) have increased the responsibilities of the EU AR. One significant change is that the EU AR now explicitly shares liability with the manufacturer for products on the market. Due to the significance of the role, it is important to choose a reputable European Authorized Representative that is committed to acting as your partner in the market.
Note regarding the various terms
The MDR/IVDR uses the term “authorised representative”, the EU Harmonized Standard EN ISO 15223-1 uses the term “authorized representative in the European Community/European Union”, and an “EC REP” symbol is used to indicate the EU Authorized Representative. They all mean the same thing.
What does the EU Authorized Rep do?
In addition to acting as a liaison with the European national Competent Authorities, the European Authorised Representative is responsible for the items below.
Before Market
- Verify that the manufacturer’s technical documentation is drawn up in accordance with the corresponding conformity procedure, i.e., the manufacturer has appropriately CE marked the device.
- Maintain a copy of the technical file and CE marking certificate, for each device they represents.
- Provide authorization to include EC Representative’s name and address on manufacturer’s medical device labeling and any other relevant documentation.
- Execute agreement (mandate) with the manufacturer to detail obligations of both manufacturer and EU AR throughout lifetime of the product in the EU market.
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During Lifetime of Service
- Review and verify manufacturer’s EUDAMED Single Registration Number (SRN) application. The Competent Authority will perform the final review and issue the SRN.
- Ensure the manufacturer has met its registration obligations.
- Maintain a copy of the technical documentation and CE mark 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 EU 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.
Additional Support
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.
Does the EU AR need to be on the device label?
Under the MDR and IVDR, the name and address of the EU AR must appear on the device label. It is not required to place the EU AR’s information on the Instructions for Use (IFU), although it may be good practice for better traceability, e.g, if the product label/package is discarded by the user.
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 EC Representative’s 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.
The EU Authorized Representative is also listed in the Declaration of Conformity and the Notified Body CE Marking Certificate (if applicable).
Process to transfer Authorized Representatives
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 a service provider that will best partner with them throughout their commercialization journey in Europe.
What about the United Kingdom and Switzerland?
The United Kingdom withdrew from the European Union. Therefore, manufacturers must now appoint a separate UK Responsible Person (UKRP) 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 service 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.