The postponement of the European Union Medical Device Regulation (EU MDR) deadline to May 26, 2021, will give economic operators (EOs) – businesses and other organizations that supply goods and/or services to the medical manufacturing industry – additional time to map out their supply chain and implement their compliance strategy. However, to ensure full compliance with EU MDR, some businesses may require greater clarification on EO responsibilities. According to a 2019 survey among 200 industry leaders, 28% of medical device companies have yet to start working on EO requirements, while 40% are still in the process of identifying what the requirements are.
EOs encompass entities with an economic interest in medical devices – manufacturers, authorized representatives (ARs), importers, and distributors. Compliance requirements that once fell primarily to legal manufacturers are now extended to other stakeholders responsible for making medical devices available, meaning all EO entities now play a more active role in ensuring that non-compliant devices don’t reach the market. The new obligations require medical devices to undergo multiple checks across the supply chain before being placed on the EU market, with each entity serving as a control on others. Manufacturers, ARs, and importers will share in legal responsibility and liability, meaning one non-compliant EO can lead to significant repercussions for the whole supply chain.
Manufacturers must now ensure that ARs, importers, and distributors are also in compliance. The regulation also introduces entirely new requirements for two of the four EO entities – importers and distributors.
Extended compliance responsibilities
Before the EU MDR goes into effect, manufacturers must introduce proactive post-market surveillance, implement and maintain a risk management system, and apply unique device identifiers (UDIs) for enhanced identification and traceability of medical devices. In accordance with Article 10, manufacturers must also meet new requirements for maintenance of technical documentation and ensure that their declarations of conformity (DoCs) and relevant certificates are kept for 10 years to 15 years after a device’s placement on the market, while guaranteeing ARs permanent access to this documentation.
Additionally, manufacturers will need to register themselves and their devices in the European database of medical devices (EUDAMED) or whichever alternative EO registration system is adopted until full implementation of EUDAMED. Implementation of the database, which aims to improve transparency and coordination between EOs, is not expected to begin until 2022, but preparation for future EUDAMED reporting should remain a priority. With all EOs except distributors required to register in EUDAMED, it’s critical for manufacturers to start mapping out their supply chains and identifying each EO entity covered by Article 2 of the EU MDR. Otherwise, businesses risk being caught unaware in the future if any of their EOs fail compliance checks, which could impact their access to Europe.
For a non-EU based manufacturer, a device can only be made available on the European market through an AR’s designation. With the new regulation, the AR’s mandate by the manufacturer must include verification of the device’s DoC and confirmation that the manufacturer has complied with registration obligations. ARs must also be registered under EUDAMED and have access to a person responsible for regulatory compliance (PRRC). ARs will therefore take on increased legal responsibility as, according to Article 11 of the EU MDR, it’s their duty to terminate the mandate with the manufacturers if they fail to comply with their obligations.
ARs will now be held severally and jointly liable alongside the manufacturer for placing a defective device on the market, and they must ensure sufficient financial coverage in respect to potential liability as set out in Article 10. In previous directives, importers had no regulatory obligations. Now, they play a crucial role in ensuring only compliant medical devices are placed on the market. This requires having a system in place for immediate notification to the manufacturer, AR, and competent authority should they identify a non-conforming device. Moreover, with shared liability, it’s now the importer’s responsibility to verify whether the legal manufacturer located outside the EU has the technical, scientific, and financial capacity to continue manufacturing an EU MDR compliant device. They will also be required to keep a copy of the DoC and copies of certificates, amendments, and supplements, as well as ensuring devices are labelled with information for importer identification.
Despite not being listed as jointly and severally liable under the new MDR (if they don’t also act as importers) and being exempt from registration in EUDAMED, distributors must ensure requirements concerning CE Marking, the EU DoC, and the allocation of a UDI have been met by manufacturers. They’re also required to act with due care in relation to EU MDR requirements and ensure corrective action is taken if a non-compliant device is made available on the market. They must then ensure timely notification to the manufacturer, AR, importer, and competent authority so appropriate remedial action can be taken.
With greater responsibilities on the shoulders of EOs, a strategic approach is crucial to ensuring compliance. It’s in the legal manufacturer’s best interests to identify EOs across the supply chain to guarantee compliance and ensure continued market access, especially given the new responsibilities that the EU MDR places on importers, ARs, and distributors. This also implies making sure that ARs and the PRRC have the right mechanisms in place to stop a non-compliant product from reaching the market.
Education at the senior level, internal training, and resource evaluation will be key to navigating the process. Bringing the executive level into the conversation is critical to building compliance culture, as well as extending EU MDR training to the whole organization, not just regulatory and management teams. Manufacturers will likely face a growing need for resources as part of long-term EU MDR compliance. Therefore, they must ensure that they have the right personnel in place to manage EOs through supplier quality and audit teams.
Small businesses in particular may struggle with verifying their supply chain compliance in addition to other regulatory pressures, but the same could apply to larger companies when dealing with EO entities spread across a multinational supply chain. However, the implementation of EU MDR could also offer EO entities, especially importers and distributors, an opportunity to be at the forefront of their competitors. Considering these unprecedented changes, reaching out to external experts for further guidance will prove highly beneficial to businesses that seek to stay ahead of the curve, helping them secure access to the European market.