When the European Union passed the Medical Device Regulation (MDR) back in April 2017, economic operators involved in the importation and distribution of medical devices became subject to new regulatory changes that would affect their ability to conduct business within the European Economic Area.
According to Article 2 of the MDR, economic operators are defined as either “a manufacturer, an authorized representative, an importer, or a distributor” of medical devices. A medical device is defined as “any instrument, apparatus, appliance, software, implant, reagent, material or other article” intended to be used for the diagnosis, prevention, or treatment of diseases and injuries. Medical devices include products such as thermometers, wheelchairs, x-ray machines, syringes, and pacemakers.
One of the most important changes stemming from the 2017 MDR update is that although each economic operator is responsible for compliance with the new MDR requirements individually, operators must also confirm that all previous operators in the distribution chain have adhered to regulations, too.
This “checks and balances” system expands the role of accountability from manufacturers alone to also include importers and distributors. Here’s an overview of how the new MDR affects each economic operator within the supply chain as a medical device goes to market.
What are the new requirements for manufacturers?
Article 10 of the MDR outlines the requirements that medical device manufacturers must follow. These regulations broadly include establishing a risk management system and a quality management system, as well as appointing a European Authorized Representative to ensure that an EU Declaration of Conformity and the proper technical documentation have been created for each device.
Manufacturers must also ensure the competent authorities in the Member State have easy access to technical documentation for medical devices, and that this documentation is translated into the appropriate language. In the event that non-conforming devices are currently on the market, the manufacturer must take “necessary corrective action,” such as withdrawing or recalling the device.
What are the new requirements for importers?
Article 13 delineates the general obligations for importers. In order for a medical device to go to market, importers must ensure that the device has been CE marked; includes an EU declaration of conformity, the required labels, and instructions for use; and as needed, includes a unique device identifier (UDI) assigned by the manufacturer.
Importers must also include an additional label indicating the importer’s name and/or registered trademark, their registered place of business, and contact information. Importers bear a greater burden than manufacturers in regard to recording complaints of non-conforming devices and providing this information to the manufacturers, distributors, and competent authorities for investigation and corrective action. Importers must also register an imported device in an electronic system which will reside in the Eudamed database.
What are the new requirements for distributors?
Article 14 offers a series of new obligations for distributors. Similar to importers, distributors must ensure that the device has been CE marked and includes an EU declaration of conformity and UDI. If a distributor believes that a device is not in conformity with MDR requirements, it will not bring the device to market and will instead inform the manufacturer and importer that the device must be brought into conformity.
Distributors must also record complaints from users or healthcare professionals and send this information to the manufacturer and importer, while also working together with the competent authorities to reduce the risks associated with devices available on the market.
Questions on compliance?
Under the new MDR requirements, medical devices are double- and triple-checked for compliance with the goal of improving quality and safety. If you need assistance bringing your quality control, risk management system, or device labeling into compliance, contact a ULG specialist today.