Beth Crandall, managing director, global solutions delivery leader at Maetrics, outlines the specific changes, how they will affect each entity, and their role in this new regulatory framework. Crandall also warns against the potential outcomes of non-compliance.
Since the EU Medical Device Regulation (EU MDR) introduced the concept of “Economic Operators” (EOs), companies have had to work to understand and implement the requirements for these entities. However, according to a 2019 study, over a quarter (28%) of medical device manufacturers surveyed had not yet started to address these requirements for EOs, or to identify the specific entities within their supply chains.1 In fact, some businesses may need greater clarification on the definition and responsibilities of EOs within this new regulatory framework in order to effectively implement these changes.
Beth Crandall
Companies must be aware of their regulatory responsibilities when placing products on the EU market. 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. There are now requirements for importers, distributors and authorised representatives as well as manufacturers. 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. The recent delay of the EU MDR deadline to 26th May 2021 is therefore a welcome development for the industry as it will allow businesses more time to prepare.
Shared compliance
The EU MDR considers manufacturers, authorised representatives, importers and distributors as EOs because they all have an economic interest in the medical device. The most significant change in terms of responsibilities is the sharing of compliance and legal liability, and it impacts the entire supply chain. With the exception of distributors, the EOs are jointly liable for devices. This means that one non-compliant entity can have direct legal implications on the rest. Therefore, each EO should have a clear overview of their own and shared responsibilities, in order to monitor the processes accordingly.
Changes in regulatory requirements for EOs
Compared to the previous medical device directives, there are many new responsibilities for manufacturers. Some of the most significant responsibilities include new requirements related to clinical investigation and evaluation, proactive post-market surveillance, Unique Device Identification (UDI), and addressing the use of materials of concern. As it pertains to EOs, manufacturers will need to use their supplier control processes to ensure all EOs across the supply chain have met their requirements. The first step in that process is to map out the supply chain and identify each EO according to Article 2 of the EU MDR. In this way, they will be able to verify the responsibilities of each EO and ensure their capacity to fulfil these obligations. In addition to this, manufacturers will have to be registered and will have to register the other entities in Eudamed - the European database on medical devices created in the context of the EU MDR. This registration process represents another challenge; due to the postponement of Eudamed’s implementation to 2022, entities will have to make sure they are gathering the necessary data in the meantime and may potentially have to use an alternative registration method until Eudamed is fully available. Certain modules may be released in advance of the application date to facilitate the transition process.
Authorised representatives, namely entities within the European Union that have been designated by manufacturers outside the Union to act on their behalf, must also be registered in Eudamed or the alternative registration method and must have access to a Person Responsible for Regulatory Compliance (PRRC). As stipulated in the EU MDR, authorised representatives will share liability for defective devices with manufacturers and are now assigned a more active role in verifying compliance.
Importers will see a significant change to their expectations and requirements. 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. Each entity wanting to introduce new medical products onto the European market now has obligations in terms of non-compliant products, product recalls and vigilance incidents. These responsibilities include monitoring product recalls, vigilance incidents and non-conforming products. Importers must have a system in place to notify the manufacturer, the authorised representative and the competent authority upon finding a non-conforming 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. There may need to be a radical shift in thinking and specific expertise in order for many importers to implement compliant processes effectively.
In the cases where a distributor is not also the importer, there are new requirements for these entities that take the products the rest of the way in the journey of placing a device on the market. An entity that is only a distributor is not explicitly listed as being jointly and severally liable in case of non-conformity. Distributors are also not required to be registered in Eudamed. However, they do have to verify the CE mark, the EU Declaration of Conformity and the UDIs (once the UDI requirements implemented and where applicable) of medical devices. Another important requirement for distributors pertains to their contractual agreements, as they will have a limited time frame to notify the manufacturers of specific device-related incidents, for which they will need to evaluate existing systems to make sure they can meet these deadlines. The EU MDR therefore significantly increases distributors’ responsibilities, especially considering that they had no regulatory obligations under the previous directives.
Practical solutions for the new EU MDR
There are two important factors for achieving successful EO compliance: Resources and communication. Having the right personnel with an understanding of and experience in these requirements will play a key role in successful implementation within all EO entities, including for the manufacturer’s supplier controls and audits. This includes legal teams and management, who must be kept informed of new regulatory requirements and any changes that may need to be made. As mentioned above, manufacturers need to focus on understanding and mapping out the different entities that are part of the supply chain. They must then verify that all entities are willing and able to adapt to the EU MDR and committed to working together. This includes ensuring that authorised representatives and the PRRC have the right mechanisms in place to prevent non-compliant products from entering the market and to stop distribution if needed.
These tasks are likely to put additional pressure on smaller companies. Larger companies will also face new challenges, especially as their supply chains are more complex and may span multiple countries. This can also be an opportunity for some entities, especially importers and distributors, to adapt quickly and be a market leader in implementing these requirements in a practical, fast and effective way. Conversely, if EO entities fail to adapt promptly, they may lose market access and also risk legal ramifications. The support of external experts may be of great help in taking the pressure off manufacturers and other EOs with the transition to EU MDR compliance. Although there is now more time to prepare, the learning curve can be reduced, and more efficient processes can be designed by utilising resources with proven experience.
Reference
1. The Race to EU MDR Compliance Continues, KMPG, 2019