Article 13 of the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) includes a new requirement to appoint an importer if your company has no legal entity in Europe. Your importer is responsible for verifying your compliance with the MDR and IVDR. This may be a little confusing because you may already have an EU Authorized Representative (EC REP) and you may be wondering what distinguishes the role of each party. That’s an excellent question. Let’s take a quick look at the responsibilities of your Authorized Representative and compare to those of your importer.
NOTE: We make reference to Chapter 2, Articles 11 and 13 of the MDR below. You can refer to the exact language specified in those articles here.
Your EU Authorized Representative (EC REP) and EU Importer both must do the following:
* This table shows common areas of responsibility between the EU Importer or EU Authorized Representative and is not intended to be comprehensive. Read MDR Articles 11 and 13 carefully.
MedEnvoy can act as your independent EU importer and EC REP. Request a proposal.
Additional responsibilities your EU Importer has that your Authorized Representative does not:
Your Authorized Representative (EC REP) reviews and confirms that the device is CE Marked, has appropriate documentation supporting CE Marking, confirms all information is complete and maintains access to client technical documentation. After this is done, the EC REP remains available to support the client in vigilance related matters. In addition to the shared responsibilities noted in the table above, your EU importer is also responsible for:
1. Verifying that labeling and accompanying Instructions for Use are correct/present. See MDR Article 13(2c)
2. Verifying that the manufacturer, EU Importer and EU Authorized Representative have been identified. See MDR Article 13(2b)
3. Verifying that the device storage and transportation conditions don’t jeopardize compliance with General Safety and Performance Requirements (GSPR). See MDR Article 13(5)
4. Maintaining a register of complaints, non-conforming devices, recalls and withdrawals – See MDR Article 13(6)
5. Ensuring that the manufacturer has assigned UDI to devices - See MDR Article 13(2d)
Differences in liability exposure
One of key differences between the Authorized Representative and the importer has to do with exposure. Your contract with your authorized representative (and the amount they charge) takes into account the fact that they can be held legally liable for your defective devices sold in Europe per MDR Article 11(5). Similarly, your Importer has significant exposure in that they can be held financially liable for your non-compliance with the MDR. The difference here is that the importer is responsible for “placing the device on the market” – something your Authorized Representative does not do.
Furthermore, EU Regulation 2019/1020 takes effect in 2021 and supplements the MDR and IVDR. Article 15 states the following:
Recovery of costs by market surveillance authorities
1.Member States may authorise their market surveillance authorities to reclaim from the relevant economic operator the totality of the costs of their activities with respect to instances of non-compliance. 2.The costs referred to in paragraph 1 of this Article may include the costs of carrying out testing, the costs of taking measures in accordance with Article 28(1) and (2), the costs of storage and the costs of activities relating to products that are found to be non-compliant and are subject to corrective action prior to their release for free circulation or their placing on the market.
As an example, the Dutch Competent Authority (IGJ - Inspectie Gezondheidszorg en Jeugd), can summon the Importer to stop its activities and impose penalties for as long as the undesired situation remains unchanged. Based on this, you can see that your EU importer is much more involved in the making sure your devices are compliant with the regulations than your EU Authorized Representative. That's why most authorized representatives, distributors and third-party logistics providers are reluctant to take on the role of importer.