European Medical Device Importers and Distributors Have New Regulatory Responsibilities Under EU MDR Articles 13 and 14
When the European Medical Device Regulation (2017/745) was published in 2017, few medical device importers and distributors were aware of the new requirements that would be placed on them. Most of the compliance focus under the Medical Devices Directive (MDD 93/42/EEC) was squarely centered on manufacturers. In fact, the word “importer” only appears three times in the entire MDD and the word “distributor” does not appear at all! The EU MDR, however, elevates the importance of all economic operators, and “importer” and “distributor” appear dozens of times throughout the regulation. That should tell you something about how EU regulators now view the importance of the supply chain through the entire life cycle of the device.
Manufacturers and their associated economic operators need to understand the new European MDR requirements that take effect in May 2021. We will talk about these changes and make reference to several Articles within the EU MDR, so we recommend downloading this PDF copy of the EU MDR that includes a super-convenient linkable Table of Contents.
Specific EU MDR 2017/745 requirements for device importers and distributors
Let’s start with the initial importation process. Perhaps the biggest change is that the EU MDR requires the importer and distributor to verify that the manufacturer and device meet the European MDR requirements before the device is imported or sold into the European Union. Specifically, Articles 13 and 14 of the EU MDR reinforce (and add specificity to) the need for supply chain economic operators to do the following:
- Verify that the medical device has CE Marking by getting a copy of the device’s CE certificate and/or the Declaration of Conformity. (This applies to importers and distributors.)
- Ensure that the manufacturer has appointed an Authorized Representative (AR) in accordance with MDR Article 11. (This applies to importers.)
- Make sure the device is labeled properly and has instructions for use (IFU) in appropriate languages for the market(s) in which it will be sold. (This applies to importers and distributors.)
- Make sure the manufacturer has applied a Unique Device Identifier (UDI) in accordance with MDR Article 27. (This applies to importers and distributors.)
Technically, these requirements are already mandated in Section 3.3 of the Blue Guide on CE Marking published in 2016. Also, this 29-page guidance document published in February 2018 by the Irish HPRA has extracted Articles of the EU MDR and IVDR that affect distributors and makes other suggestions for distributors. It’s a very useful reference.
As an aside, if a device is made in Germany and “imported” into Spain, this does not technically constitute an import because the operation takes place within the European Union. That may not be true for devices entering the UK from the EU after Brexit.
Additional traceability requirements for medical device importers
Medical device manufacturers have always been required to add the name and contact information for their Authorized Representative to their labeling. However, in an effort to improve traceability, Article 13.3 of the EU MDR now dictates that “Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted, so that their location can be established. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer” (emphasis added). While placing the name of the importer directly on the device may not seem feasible, including this information in the packaging documents seems more likely.
Importers (and distributors also acting as the importer) will also be responsible for checking that the manufacturer has added the appropriate information about the device into the new EUDAMED database, which is anticipated to be operational in 2022. Importers will additionally be required to add their own information to the database as outlined in Article 31. Regardless of whether you are an importer, distributor, Authorized Representative, or manufacturer, read Article 31 because it outlines the EUDAMED registration process. Article 25 also states that “Distributors and importers shall co-operate with manufacturers or Authorized Representatives to achieve an appropriate level of traceability of devices.”
Finally, it is the responsibility of importers to maintain a copy of the Declaration of Conformity and associated CE Marking certificate on file for at least 10 years after the last device has been placed on the EU market. This requirement does not apply to distributors.
Are we having fun yet? Wait, there’s more!
Importers and distributors are responsible for tracking and reporting complaints
Article 13.6 of the EU MDR specifically states that “Importers shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and provide the manufacturer, Authorized Representative and distributors with any information requested by them, in order to allow them to investigate complaints.” (Article 14.5 has similar language applicable to distributors.) There are also obligations to report all complaints or reports to the manufacturer and their Authorized Representative. It may seem redundant to have the importer, distributor, and manufacturer tracking complaints, but Notified Bodies and Competent Authorities essentially want to have more than “one source of truth” as to what is happening with product safety in the marketplace.
Implementation of a quality management system
While there is no specific requirement for importers and distributors to implement a quality management system (QMS) as Article 10 stipulates that manufacturers must do, we expect there will be components of a QMS required. In Articles 13 and 14 there is wording to the effect of “… shall ensure that…storage and transport conditions do not jeopardise its compliance with general safety and performance requirements.” Also, you will recall that we earlier mentioned the requirement to keep a registry of complaints, recall management, and potentially other postmarket information. Finally, if a distributor changes anything about a device – such as adding translated IFUs or repackaging its case packs into smaller quantities – this requires documented processes. All of these activities would presume that applicable parts of a QMS are implemented by an importer or distributor based on activities they are doing. Therefore, it is essential that medical device manufacturers understand the entire life cycle of the product through the distribution network.
Is your fulfillment partner considered an EU distributor?
As we mentioned earlier, you really should examine the 2016 version of the Blue Guide. It’s not specific to medical devices, but section 3.4 talks about distributors and does recognize that if the services provided by a fulfillment company sometimes go beyond simple package “clearance, sorting, transport and delivery” they should be considered distributors and regulated as such. Thus, if you are using the services of a fulfillment provider and they are doing things such as storing products, packaging/relabeling, handling customer returns, etc., they might be considered a distributor by EU regulators. These partners would also need applicable parts of a quality management system to ensure there is no jeopardy to the general safety or performance of the product.
Contracts between medical device manufacturers and EU-based importers
In light of all the changes leading up to the EU MDR compliance date in 2021, manufacturers need to take a careful look at their contracts with importers and distributors. If the contracts extend beyond May 2021 (when the EU MDR takes effect) they likely will need to be modified. If they expire before then, consider how things will change after the May 2021 implementation date:
- You may need to negotiate new contracts if current contracts extend beyond May 2021.
- Describe how often monitoring of regulatory compliance throughout the device’s life cycle must be conducted.
- Importers and distributors may need to implement applicable parts of a QMS using ISO 13485:2016 as a base or require certification.
- Competent Authorities are likely to impose penalties on nonconforming Economic Operators.
This does not mean the importer now plays the role of EU overlord, but importers should realize that they have a legal obligation to do these things. Distributors also have roles and responsibilities, but emphasis is placed on importers because most often the initial importer is also the distributor. Many importers and/or distributors may not realize that they will be “jointly and severally liable” for the device on the market along with the Authorized Representative and manufacturer. Keep this in mind if your AR is a local EU-based subsidiary because if trouble happens in the distribution chain, someone is coming after all economic operators in the supply chain, including the AR.
Taking the next step toward EU MDR compliance
Whether you are a manufacturer, distributor, or importer, there’s a lot to do between now and 2021. You don’t have to navigate the morass of regulations. Oriel STAT A MATRIX can provide training on the changes in the EU Medical Device Regulation, consulting on ISO 13485, or specific EU MDR advisory support on compliance issues related to supply chain partners.