Kristina Zvonar Brkic If you are an organisation within the EU medical device supply chain, then meeting the requirements of the new Medical Device Regulation (MDR) will become critical to remaining in your role. One of the crucial concepts to understand is that of your role and obligation as an economic operator in the medical device supply chain. Your economic operator designation will determine the roles, obligations, and regulatory functions you will need to meet in the European Union medical device supply chain. Since these roles are linked to the legal liability should anything happen, it is critical that you understand what you need to do.
Who are economic operators in the MDR?
- Manufacturers – responsible for design, development, manufacturing, and support of medical devices
- Authorised representatives – act on the manufacturer’s behalf in relation to the manufacturer’s obligations under the MDR regulations
- Importers – responsible for the placement of a non-EU product on the EU market
- Distributors – provide a product on the market up to the time of commissioning
What does “economic operator” mean?
When considering public service, an operator is any entity that supplies goods, services, or public works in the context of that market. Within the medical device supply chain, there are many operators supplying essential roles to make the market work, and having distinct roles for these operators is critical for assessing legal liability should something go wrong. To this end, the EU MDR/IVR has assigned roles to different economic operators in an effort to distribute legal liability based on the point of noncompliance.
In the EU MDR, the economic operators have distinct roles and obligations they need to meet, making this assignment of legal liability much easier. An economic operator is any entity that is involved in facilitating placing a medical device on the EU market, and the MDR identifies many different types of organisations within the supply chain as detailed below.
What is an economic operator in the MDR?
There are four types of organisation in the EU medical device regulations that are called economic operators. These operators are often referred to with the acronym MAID: Manufacturers, Authorised Representatives, Importers, and Distributors. These economic operators are defined in Article 2 of the MDR and IVDR Page 18, and it is expected that all of these members of the medical supply chain are compliant with the EU MDR.
As an EU MDR economic operator, your organisation will have distinct roles and obligations that need to be met. Meeting these requirements will be heavily enforced as part of the new EU MDR focus, to better manage within the medical device supply chain which organisations are responsible for which activities. Remember, this focus on economic operators is about distributing responsibilities so that legal liability can be assessed easily in cases of nonconformity.
Economic Operators’ roles and obligations under the MDR
The four types of economic operators have unique, but harmonised, roles and obligations in the MDR regulations in articles 10, 11, 13, and 14. As can be seen in the listing, not all of these economic operators necessarily have an individual designated as the person responsible for regulatory compliance (PRRC). Here are the responsibilities for economic operators:
Manufacturers are covered in Article 10: General obligations of manufacturers.
- Roles – Design, development, and manufacture of medical devices (including lifetime support)
- Obligations in the MDR – EUDAMED registration, create technical documentation, design, development, manufacture, assembly, handling, storage, distribution, corrective actions, UDI labelling, complaints, liability coverage, post-market surveillance, and PRRC
Authorised representatives are covered in Article 11: Authorised Representatives.
- Roles – Entities within the EU with written agreements to act on behalf of a manufacturer located outside the EU to meet MDR obligations
- Obligations in the MDR – EUDAMED registration, maintain a copy of technical documentation, documentation check, registration check, audit support, post-market surveillance, compliance obligations, supplemental liability coverage, national administrative tasks, and PRRC
Importers are covered in Article 13: General Obligations of Importers.
- Roles – Responsible for placing a non-EU product on the EU market, but do not act on the manufacturer’s behalf
- Obligations in the MDR – EUDAMED registration, maintain copy of technical documentation, ensure label contains required information, verify IFU, check that maintenance conditions are respected, and PRRC
Distributors are covered in Article 14: General Obligations of Distributors.
- Roles – Provide a product of another manufacturer up to the time of commissioning
- Obligations in the MDR – Ensure CE marking, EU declaration of conformity, unique device identifiers (UDIs), traceability, labels and instructions (in official language), verify importer name is on each device, due care & transport, participation in corrective action, verify IFU, verify declaration of conformity, notify authorities, register recalls, complaints and device nonconformity, PRRC not required
Person responsible for regulatory compliance (PRRC)
As noted above, many of these economic operators require a person responsible for regulatory compliance, but what is the role of the PRRC? The role of the PRRC, unique to the MDR, is defined in Article 15. The PRRC is responsible for maintaining the compliance status of the medical devices within an economic operator. The employee within the economic operator selected for this role must have the appropriate certifications and expertise for the MDR compliance process. The PRRC may have other roles in the organisation as well, and needs to have the support and empowerment of senior management to be able to carry out their duties, even if they are not a member of top management themselves.
The person chosen as PRRC must have at least one year of experience with Quality Management Systems (QMS) for medical devices, formal certification such as a university degree or diploma, and enough expertise in the relevant medical device. The PRRC then ensures device conformity within the QMS, recall processes, post-market surveillance, and availability of device declaration of conformity and technical documentation when requested.
Importance of achieving compliance
If you are in the medical device industry in the EU, then you are an economic operator according to the EU medical device regulation. As this role is tied to legal liability, it is critical that you understand how you fit into the economic operator framework and what your roles and obligations are, and ensure that you meet the new responsibilities if you are to continue to do business in the European Union.
To learn more about the MDR requirements and the mandatory documentation, download this free white paper: EU MDR Checklist of Mandatory Documents.
