By Chad Reynolds, Maetrics
Although the new requirements relating to economic operators (EOs) under the EU Medical Device Regulation (EU MDR) may still raise questions for manufacturers, the recent delay of the date of application by one year will give the industry additional time to get their regulatory matters in order. Considering that many manufacturers are still going through the steps to confirm which entities qualify as EOs within their supply chain, the postponement of the EU MDR deadline until May 26, 2021 is a welcome development for all involved. With such significant changes being implemented, it is instructive to outline the key aspects of these new EO responsibilities to help businesses use the time they have left as efficiently as possible.
New Requirements For Industry Stakeholders
Under the previous directive, medical device compliance requirements resided primarily with their legal manufacturers. The EU MDR has changed this for good, with additional industry stakeholders taking on new responsibilities and roles to guarantee that all medical devices reaching the market are fully compliant with the new regulation. Namely, the EU MDR introduces new requirements for importers, distributors, and authorised representatives, which are collectively referred to as “economic operators” along with manufacturers. This new policy of sharing compliance across the supply chain is an important component of the EU MDR. The idea is that each EO entity serves as a control on the others, with each device receiving a number of checks throughout the process of it being brought to market. The other implication of this arrangement is that any compliance issues emerging from any one of the EO entities can have direct legal implications on the other EOs in the supply chain. Once the EU MDR goes into effect less than one year from now, all EO entities — with the exception of distributors, who are not listed as liable — will be made jointly and severally liable for device compliance. These EO entities will need to make arrangements to ensure they have financial coverage in case any issues arise.
Identifying All EOs Within The Supply Chain
Manufacturers will play a key role in supervising and controlling their supply chain. Ensuring that all EOs across their network are in compliance will be critical to ensuring uninterrupted distribution of their devices. It will therefore serve the best interests of the manufacturer to identify and actively help their EOs reach conformity, especially given that a number of EOs are likely to be unaccustomed to this level of verification responsibility.
Manufacturers hoping to continue placing devices on the market following the date of application should therefore take the necessary steps to map out their supply chain and identify all EOs as specified in Article 2 of the EU MDR. This formative step will act as a foundation to the next: assessing and confirming the ability of their EOs to meet all obligations. Some players may even decide to withdraw from offering services to the medical device and diagnostic industries once the new regulation goes into effect, so it is critical that manufacturers stay informed of their EOs’ EU MDR readiness. On their side, manufacturers need to ensure that they are themselves equipped with the right personnel to manage EOs within supplier quality and audit teams, as well as legal support for contract management.
Importers, Distributors Will Play Key Roles
Article 2 of the EU MDR defines importers as the entities responsible for placing devices from a third country on the EU market. Article 13 stipulates that this EO entity must now comply with specific regulatory requirements while also verifying incoming information from the manufacturer. New responsibilities include monitoring product recalls, vigilance incidents, and non-conforming products. Upon finding a non-conformity, importers must have a system in place to notify the manufacturer, the authorised representative, and the competent authority. Importers must also be able to provide samples of the device and keep a copy of the declaration of conformity of the product they are importing, as well as any copies of certificates, supplements, and amendments. To ensure effective implementation across all these unfamiliar areas, some importers may have to invest in additional resources and expertise.
Some EOs may function as both importers and distributors. Companies falling under both EO categories will therefore need to take on the responsibilities ascribed to both entities. On the other hand, for those businesses operating solely as distributors, this will be their first time taking on responsibilities relating to the compliance of the medical devices they distribute. While they are not considered jointly and severally liable in case of non-conformity as the other three EO entities are, they will nonetheless assume an active role under the EU MDR.
More specifically, distributors will play an important part in ensuring that the transport and storage conditions of the distributed products comply with the rules established by the manufacturer. They will also need to report incidents back to the manufacturer, as stipulated in their distributor agreements. Among other responsibilities, distributors must ensure that each device includes instructions for use (IFUs), a CE mark, a declaration of conformity and, once implemented and if applicable, information relating to the unique device identifier (UDI).
Bridging The Gap Between Non-EU Manufacturers And The EU Market
Authorised representatives (ARs) act as intermediaries between manufacturers from outside the EU and EU authorities. Given their position in the supply chain, ARs will also undertake new tasks relating to compliance under the EU MDR. For instance, ARs must have access to a person responsible for regulatory compliance (PRRC) within the manufacturer. Furthermore, ARs must continuously monitor the manufacturer’s compliance with its registration obligations and, depending on the condition of termination established in the mandate, end their mandate if the manufacturer acts contrary to these obligations. For this reason, the mandate between the AR and manufacturer must be in writing and available to the competent authority upon request.
All economic operators, except for distributors, must prepare to be registered in EUDAMED — the European database on medical devices — or any alternative EO registration system that is adopted until its full implementation in 2022. Manufacturers, ARs, and importers need to keep informed as new guidance is provided and as EUDAMED modules gradually become available.1
Educating Executive Management
With so many new assigned responsibilities for EOs under the EU MDR, regulatory teams must educate executive management about the implications of these changes. This will be essential to forming the culture of compliance and quality required across the business to maintain compliance in the long term. Bringing executives into this conversation will also be useful during assessments of legal impact, product portfolio decisions, and resource evaluations. Finally, keeping the executive level informed of the potential risks associated with non-compliance, more specifically the risk of losing access to markets and facing legal liabilities, is critical. We are less than a year away from the date of application, so all EO entities should begin working on their new obligations immediately if they have not done so already. In view of the unprecedented changes that the EU MDR represents for all EO entities, companies may want to consider reaching out to external experts for support and guidance on establishing a totally compliant network of EOs.
About The Author:
Chad Reynolds is a director of Maetrics Solutions Delivery (SD) and leads its SD teams in Europe. Prior to Maetrics, he spent eight years managing a global service organization and 11 years leading quality and regulatory compliance roles with leading medical device companies. With Maetrics, Reynolds has successfully led a two-year QMS remediation and integration project and serves as an SD director for some of the company’s largest clients. He has proven skills in global QMS remediation and integration, EU MDR, economic operators, ISO13485:2016 and MDSAP gap identification and assessment, risk management to ISO 14971:2012, and compliance project implementation. He is a certified quality auditor to ISO 9001:2015 and ISO 13485:2016.
For more detail on the new responsibilities for economic operators required by the EU MDR, download the Maetrics white paper “Economic Operators: Whose Problem Is It Anyway?”