In the rapidly evolving landscape of medical device regulations, understanding the roles and responsibilities of economic operators is pivotal. With the introduction of the European Medical Device Regulation (EU MDR) and the In Vitro Diagnostic Regulation (IVDR), the roles of Economic Operators have undergone significant changes and each one of them plays essential role in ensuring the safety and compliance of medical devices and in vitro diagnostic devices (IVDs) within the European Union. The entities recognized as economic operators in accordance with the EU MDR and EU IVDR encompass:
Manufacturers of Medical Devices
Collectively, these entities can be referred to by the acronym "MAID."
Under EU MDR and IVDR, The ‘Manufacturer’ is a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark. The manufacturer is the entity responsible for designing, manufacturing, and placing a medical device or IVD on the market. Manufacturers can be located within or outside the EU. The systems and procedure pack manufacturer is a natural or legal person who combines CE-marked devices such that they are compatible with the intended purpose and within the limits of use specified by their manufacturers and is alos considered as an Economic Operator. The obligations of a Manufacturer are defined under Article 13 of EU MDR. Their responsibilities include:
Ensuring compliance with EU MDR or IVDR stipulations, encompassing robust Quality Management and Risk Management Systems.
Obligation to accomplish Actor registration in EUDAMED and secure a Single Registration Number (SRN).
Affixing the CE marking to devices that adhere to EU regulatory standards and creating the EU Declaration of Conformity (DoC).
Guaranteeing compliance with Unique Device Identification (UDI) requirements for the device.
Conducting complete Clinical Evaluation, compiling, and maintaining technical documentation.
Designating a Person Responsible for Regulatory Compliance (PRRC).
Performing the necessary Post Market Surveillance activities mandated for the device class and submitting requisite Periodic Safety Update Reports (PSUR) and Post Market Surveillance Reports (PMSR) through the relevant EUDAMED modules.
Promptly reporting incidents and executing Field Safety Corrective Actions (FSCA).
European Authorized Representative (EAR)
An EAR is a natural or legal person established within the European Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under EU MDR. The obligations of an EAR are specified under Article 11 of EU MDR and IVDR. The authorized representative acts on behalf of the manufacturer regarding regulatory compliance and liaises with competent authorities. Legally responsible for any defective devices, their obligations encompass:
Necessity to complete Actor registration in EUDAMED and secure a Single Registration Number (SRN).
Verification that the manufacturer's devices align with EU requirements and have undergone requisite conformity assessments.
The appointment of a Person Responsible for Regulatory Compliance (PRRC).
Collaboration with the PRRC and responsiveness to authorities' requests.
Maintenance of a copy of the Technical Documentation and the Declaration of Conformity.
Facilitation of communication with Competent Authorities and providing support during Corrective and Preventive Actions (CAPA).
Ensuring compliance with UDI labeling and Post Market Surveillance (PMS).
According to EU MDR, the term ’Importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market.’ The manufacturer has the flexibility to select a single entity to fulfill both the roles of importer and distributor, or they may opt for one importer and multiple distributors. If the same entity assumes both roles, it is obligated to meet the responsibilities of both importer and distributor.
Article 13 defines importers as entities responsible for introducing medical devices or IVDs from outside the EU into the EU market. Their duties encompass:
Actor registration within EUDAMED must be completed, and a Single Registration Number (SRN) must be obtained.
They are responsible for confirming the manufacturer's compliance with EU regulations, including the appointment of an Authorized Representative, adherence to UDI requirements, and other regulatory measures.
They must verify that the devices bear the CE marking, have a duly prepared Declaration of Conformity, and carry appropriate labeling.
Keeping meticulous records of the imported devices is a mandatory requirement.
They are responsible for ensuring that the devices are stored and transported in accordance with the manufacturer's instructions.
In the event of device non-compliance and the need for corrective actions, cooperation with authorities is imperative.
Any complaints from the market must be promptly communicated to both the Authorized Representative (EAR) and the manufacturer.
In accordance with EU MDR and EU IVDR, the “distributor” is any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting it into service. The supply chain can involve either a single distributor or multiple distributors. The manufacturer is obligated to establish the required quality agreements directly with the primary distributor and may also request them to establish the necessary procedures and agreements with other distributors further down the supply chain. Importantly, distributors must be situated within the European Union. The Article 14 of EU MDR outlines the obligations of distributors. Their duties encompass:
Verifying the accurate labeling, CE marking, the presence of the Declaration of Conformity, and compliance with Unique Device Identification (UDI) for the devices they distribute.
Maintaining records of the distributed devices, maintaining a complaint register, and promptly communicating any market complaints to the manufacturer and the Authorized Representative (EAR).
Collaborating with manufacturers and authorities in instances of device-related issues.
Ensuring that storage and transportation conditions align with the specific requirements of the devices.
These economic operators collectively form an integral part of the regulatory framework for medical devices and IVDs in the European Union. Their roles are designed to enhance the safety, traceability, and overall compliance of these products in the EU market. Each operator has specific obligations and responsibilities, and their collaboration is essential to meet the regulatory requirements set out in EU MDR and IVDR.
Critical Considerations for Efficient Management of Your Medical Device Supply Chain and Economic Operator System
Create an exhaustive supply chain map, starting from manufacturing through to making the device accessible to end-users. In situations where the product is manufactured outside the European Union but has legal ownership within the EU, importing under EU MDR is not necessary. For manufacturers situated outside the EU, the Economic Operators would encompass the Legal Manufacturer, Importer, Distributor, and Authorized Representative.
Identify the roles played by each stakeholder within the supply chain and their respective obligations in accordance with EU MDR or EU IVDR.
Evaluate whether each economic operator within the supply chain has grasped and comprehended the requirements outlined in EU MDR and EU IVDR.
Recognize that comprehension is merely the initial step toward compliance. Assess whether these economic operators possess all the essential tools and resources needed to execute the requisite processes to adhere to the regulations effectively.
Strive to maintain an efficient and streamlined supply chain as it simplifies communication in cases of market complaints. The presence of multiple importers and distributors can complicate the supply chain. It is preferable to have a single importer and distributors capable of serving multiple markets. Opting for distributors with broader geographical reach can lead to a reduced number of distributors.
Foster robust relationships with each economic operator, ensuring transparency and clear communication—a pivotal factor for compliance with EU MDR/EU IVDR.
In cases involving the repackaging of imported devices, explore the feasibility of centralizing these activities in a single location to minimize the complexities associated with Quality Management System (QMS) and Notified Body audits or inspections.
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