The intricacies of the EU Medical Device Regulation (EU MDR) may still be unclear for many medical device manufacturers, notably the new requirements and implications related to Economic Operators (EO). The recent delay of the EU MDR deadline to May 26, 2021 is therefore a welcome development for the industry as it will allow businesses more time to prepare. In fact, a number of manufacturers are still in the process of confirming who qualifies as an EO and what their new obligations are under the regulation. Given the significant changes some of the new requirements represent, some EO entities may need to fundamentally alter their usual operations. This article highlights key aspects of these new responsibilities with the aim of helping businesses take advantage of the additional time.
Becoming Jointly and Severally Liable
While compliance to medical devices requirements was previously primarily the responsibility of the device manufacturers alone, the EU MDR now extends the responsibility to other industry stakeholders. In particular, the concept of Economic Operators introduces new requirements for Importers, Distributors, and Authorized Representatives (ARs) as well as Manufacturers. Under the new regulation, EOs share the duty of ensuring compliance. The requirements are intended to ensure that multiple checks are performed throughout the process of placing a device on the market, with each entity serving as a control on the others. This also means that compliance issues from any one of the EO entities can have direct legal implications on the other EOs in the supply chain.
The stakes are high and the impact of any of the EOs not complying with the EU MDR could have serious ramifications on the others. After the date of application, all EO entities (with the exception of distributors who are not listed as liable) will therefore need to make sure they have financial coverage as they will be made jointly and severally liable for devices.
Mapping out the Supply Chain
While compliance may increasingly be a shared enterprise under the EU MDR, manufacturers will continue to play an instrumental role in understanding and controlling their supply chain. They will use their supplier control processes to ensure that all EOs across the supply chain have met their requirements. Without this level of oversight, they could be risking their access to the European market. It is therefore in the legal manufacturer’s best interests to identify and actively help their EOs to achieve compliance, particularly because the level of verification responsibility required is new for many ARs, importers, and distributors.
If they wish to continue placing their devices on the EU market, manufacturers should therefore take the first critical step of mapping out their supply chain and identifying each EO entity as defined in Article 2 of the EU MDR. This foundational task will serve to later assess and confirm their EOs’ abilities to meet their obligations. Manufacturers should also keep in mind that the new requirements on importers, distributors, and ARs may mean that some players choose to withdraw from offering services to the medical device and diagnostic industries, rather than go through the effort and expense to become compliant and maintain that compliance. Once all EOs have been identified, manufacturers should also confirm that the right personnel are available to manage EOs through supplier quality and audit teams, and in legal for contract management.
Manufacturers must also confirm compliance to a significant number of new requirements, including proactive post-market surveillance, utilizing unique device identification (UDI), and addressing the use of materials of concern, just to name a few. Manufacturers must maintain documentation for 10-15 years after the last device has been placed on the market, as stipulated in Article 10 of the EU MDR, making it permanently available to the AR.1 Although many other national regulations already prescribed that manufacturers keep documentation for a set amount of time, the EU MDR specifically stipulates a time frame for the whole of the EU.
Identifying the Importers
Importers are the entities responsible for placing devices from a third country on the EU market, as stipulated in Article 2 of the EU MDR. This group has an entirely new role in confirming the compliance of the device and must now meet specific regulatory requirements and verify information from the manufacturer. These responsibilities include monitoring product recalls, vigilance incidents, and nonconforming products. Importers must have a system in place to notify the manufacturer, the AR and the competent authority upon finding a nonconforming product. Among other responsibilities, Importers must keep a copy of the declaration of conformity of the product they are importing, as well as any copies of certificates, supplements, and amendments. They must also be able to provide samples of the device.
Importers are now required to ensure adherence to storage and maintenance conditions specified by the manufacture. They must also check that devices are labeled as per regulations and match to their instructions for use (IFUs). Once the UDI requirements for products are implemented, starting in May 2025 for certain devices, importers will also be required to confirm that the UDI information is present on the labels where applicable. Devices must also be labeled with information allowing for importer identification, namely the Importer’s name, their registered trade name or trademark, their registered place of business, and address for contact. They must also ensure that their label does not obscure the manufacturer’s label. Given that some of these elements are entirely new to most importers, they may be required to invest in additional resources and expertise to ensure effective implementation.
Finding the Distributors
Although sometimes distributors are also importers, this is not always the case. Prior to the EU MDR, distributors had no responsibilities relating to the compliance of the medical devices they distributed. Once the new regulation comes into force in May 2021, distributors will assume a more active role. While they may not be jointly and severally liable in case of nonconformity in the way that the other EO entities are, they will still play an important role.
More concretely, distributors will need to act with due care and ensure that the transport and storage conditions of the distributed products comply with the rules laid out by the Manufacturer. They must also report any incidents back to the relevant manufacturer within their distributor agreements. Each device must include IFUs. Similarly, they must ensure that all devices have a CE mark, a Declaration of Conformity, and, once implemented and if applicable, the UDI information.
Placing Products Outside Established Member States
When manufacturers from outside the European Union wish to place their product on the market within the EU, they must designate an AR in order to do so. Under the EU MDR, ARs qualify as EOs and through this, will take on specific liability. For instance, ARs must verify that the manufacturer has complied with registration obligations and establish a condition of termination of mandate if the manufacturer acts contrary to obligations.
The AR’s mandate by the manufacturer must be in writing and be provided to the competent authority upon request. ARs must also have access to a person responsible for regulatory compliance (PRRC). These new requirements and increased legal liability present new challenges for ARs and may require organizational changes for certain businesses.
Finally, the manufacturer, ARs, and importers must all prepare to be registered in EUDAMED (European database on medical devices), or whichever alternative EO registration system is adopted until its full implementation. EUDAMED implementation is not expected to begin until 2022, so it will be important to stay up to date as new guidance is provided.
Adopting a Strategic Approach to EO Compliance
Given the number of new responsibilities that the EU MDR represents for all four economic operator entities, manufacturing businesses would do well to get their regulatory teams involved to educate the executive management about the impact of these changes. Bringing the executives into this conversation is critical to building the culture of compliance and quality that is required to ensure patient safety and proper business planning. Their involvement will also be beneficial during assessments of legal impact, product portfolio decisions, and resource evaluation, including staffing needs.
Furthermore, the executive management should stay informed about the implications of noncompliance, namely the potential risk of losing market access and facing legal liability. With only one year left to meet their new obligations, all EO entities should start working on these requirements now if they wish to have all their systems in place before the deadline in May 2021. Given the unprecedented change that these requirements represent, businesses may consider this to be an ideal time to reach out to external experts for support and guidance on achieving a fully compliant EO network.
- Medical Device Regulation, Article 10, General obligations of manufacturers, EU MDR, Article 10 (8).
This article was written by Beth Crandall, Managing Director, Global Solutions Delivery Leader at Maetrics, Indianapolis, IN. A new white paper provides greater detail on the new responsibilities for Economic Operators required by the EU MDR. Download a free copy of the paper at http://bit.ly/2SU1nlx. For more information, visit here .