With the EU MDR (European Union Medical Device Regulation) deadline inching closer on May 26th, 2021, it is necessary for the device industry to be aware of the EU MDR 2017/745 regulation for Economic Operators (EOs). As per the regulation, a Manufacturer, an Importer, a Distributor, and an Authorized Representative (AR) are considered as Economic Operators (EOs). With an aim to enhance safety and efficacy of the medical devices entering the EU market, the EU MDR regulation has laid down stringent requirements for EOs.
As the regulation holds many significant changes for EOs, to avoid confusion and serious ramifications further down their supply chains, it is instructive to outline the key requirements. Here we list out.
The Role of Economic Operators (EOs)
Authorized Representatives (ARs): An AR is responsible for EUDAMED registration, technical documentation, corrective actions, UDI labeling, Post-market Surveillance (PMS) and the Person Responsible for Regulatory Compliance (PRRC). ARs must register themselves in EUDAMED and verify that the appropriate conformity assessment procedure has been carried out by the manufacturer. An AR must keep copies of all technical documentation and declaration of conformity and certificates and make them accessible to the authorities, on request. An AR should co-operate in investigations and have permanent and continuous access to PRRC. If the manufacturer has not complied with its obligations under the regulations and is not located in the EU, the ARs will be liable for defective devices together with the manufacturer.
Manufacturers: A manufacturer’s responsibilities include EUDAMED registration, technical documentation, design, development and assembly, handling, storage and distribution, corrective actions, UDI labeling, complaints, PMS and the PRRC. The manufacturers must be registered with EUDAMED, maintain up to date technical documentation and have a PRRC with professional expertise in Regulatory affairs or Quality Management System (QMS) relating to medical devices. The QMS of a manufacturer must be certified and each medical device must have a Declaration of Conformity (DOC) and a Unique Device Identification (UDI) for greater transparency, traceability and enhanced safety. As there may be typical changes over time, manufacturers must keep the QMS and the device DOC up to date. To identify each EO, the manufacturers are advised to start mapping out their supply chains, which will later help to assess and confirm their EOs abilities to meet their obligations.
Importers: EUDAMED registration, handling, storage and distribution, corrective actions, UDI labeling and PMS are some of the responsibilities of an importer. Similar to ARs and manufacturers, the importers also have to register with EUDAMED and carefully evaluate and verify whether the legal manufacturers have the technical, scientific and financial capability to manufacture devices that are compliant with the regulation. They are entitled to take their own corrective action when they identify non-conformance and also engage in PMS activities in their own right. Importers are required to perform certain verification activities, to ensure that the devices are CE marked, UDI assigned and have a DOC in place.
Distributors: The responsibilities of a distributor span across handling storage and distribution, corrective actions, UDI labeling, complaints and PMS. A distributor must demonstrate to the competent authorities that they have verified the inclusion of required instructions for use in each device and ensured the presence of the CE mark, declaration conformity and any required UDI on the device. There is a necessity for every distributor to act with due diligence and ensure that the storage and transport conditions comply with those set out by the manufacturer, alongside capturing and sharing the customer complaints with the key stakeholders in the supply chain and beyond.
Therefore, before May 26th, 2021 – the EU MDR deadline, all the EOs must implement their respective obligations effectively, in order to have all their systems in place. It is advisable to reach out to a Regulatory expert for a compliant market-entry. Stay informed. Stay compliant.