Economic Operators
Meeting the EU MDR & IVDR compliance requirements
The requirements placed on Economic Operators have changed considerably under the new regulations. While it is the body that manufactures and markets the devices that will ultimately need to drive these changes, Economic Operators (EOs) will certainly play a major role in medical device authorisations and post-authorisation monitoring.
Economic Operators must verify regulatory requirements, manage complaints, and cooperate with the Notified Bodies and Competent Authorities. An understanding of the regulations is therefore paramount, as the new regulations will probably cause changes to Service Level Agreements and require them to be arranged as part of the MDR/IVDR readiness.
The foundations for success regarding regulatory requirements are, without doubt, communication, accessibility, and established processes.
What does “Economic Operator” mean?
When referring to public service, an operator is any entity that supplies goods, services, or public works in the context of that market. Many operators supplying essential roles to make the market work exist within the medical device supply chain. Said operators hold distinct roles, critical for assessing legal liability should something go wrong. In an effort to distribute legal liability based on the point of noncompliance, the EU MDR/IVR has assigned roles to different Economic Operators. These roles are Manufacturers, Authorized Representatives, Importers, and Distributors, sometimes collectively referred to as MAID.
Although we consider any entity involved in facilitating the placing of a medical device on the EU market as an Economic Operator, this assignment of legal liability is made easier by the fact that, in the EU MDR, the Economic Operators have distinct roles and obligations. The MDR identifies many types of organisations within the supply chain, as detailed below.
Who are Economic Operators in the MDR/IVDR?
- Manufacturers are responsible for Eudamed registration, technical documentation, design, development, manufacture, and assembly, as well as handling, storage, and distribution. Additional responsibilities, such as corrective actions, UDI labelling, complaints, post-market surveillance, and the PRRC, also fall under the remit of manufacturers.
- Representatives authorised by Eudamed are responsible for Eudamed registration, technical documentation, corrective actions, UDI labelling, post-market surveillance, and PRRC.
- Importers are responsible for the registration, handling, storage, and distribution of Eudamed, as well as corrective actions, UDI labelling, and post-market surveillance.
- Distributors are responsible for the handling, storage, and distribution of products, as well as corrective actions, UDI labelling, customer service, and post-market surveillance.
What are the regulations around the Economic Operators’ roles and specifically, what are their obligations under the MDR/IVDR?
The Economic Operators, of which there are four types, have unique, but harmonised roles and obligations under the MDR regulations in articles 10, 11, 13, and 14. As the listing shows, not all of these Economic Operators necessarily have a designated individual responsible for regulatory compliance (PRRC). We have detailed the Economic Operators’ responsibilities below:
Manufacturers – Article 10: General obligations of manufacturers.
- Roles – Design, development, and manufacture of medical devices (including lifetime support).
- Obligations in the MDR/IVDR – 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 – Article 11: Authorised Representatives.
- Roles – Entities within the EU with written agreements to act on behalf of a manufacturer outside the EU to meet MDR obligations.
- Obligations in the MDR/IVDR – 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 – 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/IVDR – EUDAMED registration, maintain a copy of technical documentation, ensure the label contains the required information, verify IFU, check that the maintenance conditions are respected, and PRRC.
Distributors – Article 14: General Obligations of Distributors.
- Roles – Provide a product of another manufacturer up to the time of commissioning.
- Obligations in the MDR/IVDR – To ensure CE marking, EU declaration of conformity, unique device identifiers (UDIs), traceability, labels and instructions for use (in official language), verify importer name is on each device, due care and 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 previously highlighted, many of these Economic Operators need an individual responsible for regulatory compliance. However, what is the role of the PRRC? Unique to the MDR, they define the role of the PRRC in Article 15 as responsible for maintaining the compliance status of the medical devices within an Economic Operator. The selected individual must possess the appropriate certifications and expertise for the MDR compliance process.
Since the individual may have other roles within the organisation, in addition to their PRRC responsibilities, it is essential that senior management support and empower the PRRC to carry out their duties, even if they are not a member of top management themselves.
A formal certification, such as a university degree or diploma, sufficient expertise in the relevant medical device, and a minimum of one years’ experience with Quality Management Systems (QMS) for medical devices, are all prerequisites for the chosen individual. The PRRC will ensure device conformity within the QMS, recall processes, post-market surveillance, and availability of device declaration of conformity and technical documentation when requested.
The importance of achieving compliance
According to the EU medical device regulation, if you are in the medical device industry in the EU, you are an Economic Operator. Since legal liability is bound to this role, it is crucial that you understand how you adhere to the Economic Operator framework and what your roles and obligations entail. Ensuring you meet the new responsibilities is essential if you continue to do business in the European Union.
CLIN-r+ top tips on being compliant:
- As early as possible, determine who your Economic Operators are, taking care to do so, as some may have multiple roles.
- Establish the legal obligations of your Economic Operators. You should consult your legal team to review contracts and highlight EARs of liability and gaps in insurance of both yourselves and your Economic Operators.
- Select the PRRC and Authorised Representatives, ensuring that the individuals who hold these positions meet the minimum criteria. Should there be any difficulties in appointing somebody that meets all the requirements, look at outsourcing, but do not delay.
- Involve your Business Development Managers as early as possible. Make sure you get their backing to help educate your Economic Operators, but also to get your Service Level Agreements updated.
To learn more about CLIN-r+ services for medical devices and IVD manufacturers, get in touch!
Resources:
Person Responsible for Regulatory Compliance (PRRC)
UDI Beginners Guide
