As per EU MDR Articles 13 and 14, Medical Device Importers and Distributors operating in the Europe have newly defined roles. The European Medical Device Regulation (2017/745) was released in the year 2017, a small number of medical device distributors and importers are thoughtful of the new requirements that would be applied on them. Most of the compliance requirements under the old Medical Devices Directive (MDD 93/42/EEC) were only focused on manufacturers. In reality, the word “distributor” does not appear at all in the whole MDD while the “importer” only appears three times in the entire MDD. The new EU MDR, conversely, raises the status of all economic operators in the supply chain, and terms like “importer” and “distributor” is reflected many times throughout the regulation. So now the EU regulators view the significance of the supply chain through the complete life cycle of the medical device. Manufacturers and related economic operators now need to comprehend the new European MDR requirements that will in force in May 2020.
Discussion of Different MDR Requirements on Importers and Distributors
Specific EU MDR 2017/745 requirements for device importers and distributors
The initial import process: The biggest update is that the EU MDR necessitates the importer and distributor to confirm that the device manufacturer and the medical device meet the European MDR requirements earlier than the device is imported or traded into the European Union. Precisely, Articles 13 and 14 of the EU MDR strengthen (and add specificity to) the prerequisite for supply chain economic operators to do the following:
- Confirm that the medical device has CE Marking by obtaining a copy of the device’s CE certificate and/or the Declaration of Conformity. It applies to both importers and distributors.
- Confirm that the manufacturer of the device has selected an Authorized Representative (AR) compliant with MDR Article 11. Exclusively it applies to importers only.
- Ensure the device is labeled appropriately and has instructions for use (IFU) in suitable languages for the target markets in which it will be traded. It applies to both importers and distributors.
- Ensure the manufacturer managed a Unique Device Identifier (UDI) compliant with MDR Article 27 for medical device traceability requirements. It applies to both importers and distributors.
Just for clarification, if a device is produced in Germany and “imported” into Spain, this does not in principally institute an import in context of the MDR; because the manufacturing process takes place within the European Union. However it is not true for the UK after Brexit.
Additional Traceability Requirements for Medical Device Importers
Medical device manufacturers have always been obligated to incorporate the contact info and name for their Authorized Representative to their marking and labeling. But, in an endeavor to enhance traceability, Article 13.3 of the EU MDR now states 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”. Whereas marking the name of the importer straightaway on the device may not seem practicable now.
Importers and those distributors who are also acting as the importer will also be accountable for verifying that the manufacturer has incorporated the suitable information about the device into the new EUDAMED database, which is expected to be working in the year 2020. Importers will furthermore be obligated to add their own data to the database as prescribed in Article 31. Irrespective of whether one is an importer, distributor, Authorized Representative, or manufacturer, one should comprehend Article 31 because it explains the EUDAMED registration process. Article 25 also explains that “Distributors and importers shall co-operate with manufacturers or Authorized Representatives to achieve an appropriate level of traceability of devices.”
Lastly, it is the obligation of importers to keep a copy of the Declaration of Conformity and related CE Marking certificate on file for as a minimum of ten years after the specific device has been positioned on the EU market. This requirement does not relate to distributors.
Distributors and Importers Are Answerable For Tracking and Reporting Complaints
Article 13.6 of the EU MDR precisely explains 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.” While Article 13.6 was discussing the responsibility of importers; Article 14.5 has analogous text applicable to distributors. There are also responsibilities to report all complaints or reports to the manufacturer and their Authorized Representative. It may appear out of work to have the importer, distributor, and manufacturer tracking complaints, but Notified Bodies and Competent Authorities basically look forward to have more than one source of information as to what is going on with safety of medical device in the European market.
Implementation of a Quality Management System
On one hand there is no particular requirement for importers and distributors to apply a quality management system (QMS) as in MDR Article 10 that directs that manufacturers to implemented QMS, however it is expected there will be some parts of a QMS required for importers and distributors. In Articles 13 and 14 there is text that binds the importer and distributor to have such storage and transportation conditions so as to avoid the dangers to device safety and performance of a medical device. Similarly if we can recall complaints management, of if the importer or distributor changes anything in Instructions for use and other requirements related to packaging, there needs to be a documented process to control that. Hence all these activities will be part of the QMS. Therefore an importer or distributor needs to check what parts of QMS are applicable to them based on activities they are performing. Consequently, it is important that medical device manufacturers comprehend the complete life cycle of the product through its distribution network.
Agreements between Medical Device Manufacturers and EU-based Importers
In view of all the modifications going for the EU MDR compliance date in 2020, manufacturers need to review with a careful assessment of all their agreements and contracts with importers and distributors. If the agreements prolong after May 2020 (when the EU MDR is going to be in effect), the agreements are probably needed to be changed. If they terminate before the due date of EU MDR, one needs to consider how things will alter after the implementation date:
- One is needed to negotiate on new agreements if present contracts go beyond May 2020.
- Define how frequently monitoring of regulatory compliance all over the medical device’s life cycle must be done.
- Importers and distributors are required to implement appropriate parts of a QMS utilizing ISO 13485:2016 as a foundation or require certification.
- Related Authorities are probable to enforce penalties on nonconforming Economic Operators.
Importers should understand that they have a legal responsibility to comply with these requirements. Distributors also have roles and responsibilities under the new MDR, but importance is stressed on importers since at times the preliminary importer is also the distributor. Many importers as well as the distributors may not understand that they will be together and separately accountable for the device on the market together with the manufacturer and Authorized Representative (AR). One thing to remember, that if anything went wrong in the supply chain of the devices, someone is coming to investigate the issue with all economic operators including the AR.
Preparing for the EU MDR compliance
Whether one’s company is a distributor, manufacturer, importer, and even authorized representative; keep this in mind that one needs to do a lot between now and the year of enforcement. Also the companies cannot afford to navigate the extended text of regulations. TS Q & E can offer suitable training and consultancy on the changes in the EU Medical Device Regulation, and how it will affect your company, and how your company should prepare, along with consultation on ISO 13485, or any other particular EU MDR advisory support on compliance issues associated to your company and any of your supply chain partners.