Under the new EU Medical Device Regulation 2017/745 (EU MDR), additional entities involved in placing a medical device on the market, alongside the manufacturer itself, now bear specific responsibilities. The new regulation lays down more stringent requirements for the ‘economic operators’ (EOs) in the supply chain, specifically: manufacturers, authorized representatives, importers, and distributors. To ensure greater traceability and enhanced safety for medical devices entering the European market, the EU MDR now introduces entirely new requirements for two of the four EO entities, namely importers and distributors.
Manufacturers will play a crucial role in ensuring that EOs within the supply chain meet their obligations. With this in mind, manufacturers should map out their supply chain as a first step, identifying importers and distributors and making sure that they are able to fulfil the new requirements. This is pivotal as failure by one entity to comply with the new provisions may affect the entire supply chain and put access to the European medical device market at risk.
Moreover, with less than one year until the implementation deadline of the EU MDR in May 2021, it is crucial that all actors involved plan their compliance activities carefully. Therefore, manufacturers and all relevant stakeholders must be fully aware of the requirements laid down by the EU MDR and their practical implications for the medical device industry.
What’s at Stake for Manufacturers and Authorized Representatives?
To place medical devices on the European market, a non-EU-based manufacturer will need to establish an authorized representative (AR) to act on their behalf with regard to the European market. Under the written mandate established between the two entities, it is the AR’s responsibility to verify and ensure that the manufacturer has complied with its registration obligations, along with the other provisions set out in the EU MDR. The AR now bears greater responsibilities and liability under the new regulation and, together with the manufacturer and the importer, can be held jointly and severally liable for defective devices placed on the market.
To this end, manufacturers should ensure that the technical documentation is up to date and that it is made permanently available to the AR. The manufacturer must also make sure to have at least one person responsible for regulatory compliance (PRRC) with professional experience in regulatory affairs or in quality management systems relating to medical devices (Article 15). The AR must also have access to a PRRC.
Manufacturers are also considered economic operators and have a significant number of new regulations to address. There are new requirements for the quality management system, risk management system, post-market surveillance, clinical evaluation and reporting, and technical documentation—just to name a few. The manufacturer’s quality management system (QMS) must be certified and the individual medical devices must have a declaration of conformity (DOC). The DOC is either self-declared for lower risk devices or obtained through formal review and approval by a notified body for higher-risk devices. Manufacturers must keep the QMS and the device DOC up to date, as there are typically changes over time. The QMS records and product documentation must be retained for a 10- to 15-year period, as laid out in Article 10.
To allow greater transparency, traceability, and enhanced safety, each device will also be assigned a ‘Unique Device Identifier’ (UDI). UDIs will facilitate device identification and will be also used when reporting serious incidents or filing corrective actions. Moreover, together with ARs and importers, manufacturers must register in the new European Database on Medical Devices (EUDAMED) and must register each medical device in the database. Despite delays in the overall database implementation, certain modules are expected to be available sooner than others. So EOs must keep up with developments related to EUDAMED in order to find themselves in a better position once the database is implemented. EOs should continue pulling together the necessary data during this transition period to be ready in time for implementation.
Importers and Distributors: A Whole New Set of Requirements
Importers will now share compliance and be held liable for the devices they place on the market. As a result, they must have a system in place to forward non-conformity complaints to the manufacturer and to promptly notify the manufacturer, the AR, and the competent authority when they believe a device has been falsified or presents serious risks. The same requirements apply to distributors; it is important to point out, however, that distributors are not listed in the MDR as being jointly and severally liable.
Importers and distributors are also responsible for conducting several verification activities. They will need to ensure that the products they put on the market are compliant, by confirming the device has been CE marked and assigned a UDI, and that a DOC is in place; importers will also need to make sure they keep a copy of the DOC and of any relevant certificates. In addition, they must ensure that storage and transport conditions set out by the manufacturers are followed and that labels, and instructions for use (IFUs), when required, are included.
These activities represent a new level of cooperation and coordination by importers and distributors with manufacturers and ARs to ensure strengthened traceability.
EU MDR Compliance: Taking the Next Step
In the journey to achieve compliance with the new EU MDR, manufacturers will have to allocate sufficient resources, making sure they have the right personnel within their quality, regulatory, supplier audit, and legal teams. Moreover, given the new requirements placed on importers and distributors, manufacturers might also want to verify whether each party is willing and able to comply with their requirements. In fact, some stakeholders might decide to withdraw from the medical device market, rather than going through the compliance process.
As a manufacturer you might be unsure of how to put appropriate processes in motion to pursue compliance with the new requirements. When it comes to larger companies with a supply chain extending across multiple markets, untangling the entities and stakeholders in compliance with the new regulations may be even more complex. Seeking external support may prove beneficial for businesses to confidently address the new EU MDR compliance requirements. Expert advice will allow companies to maximize resources and to put in place a clear plan of action, making sure that the requirements are clearly understood and integrated in the company strategy.
Maetrics’s latest whitepaper provides greater detail on the new responsibilities for Economic Operators required by the EU MDR. Download a free copy of the Maetrics paper here.