Since May 2021, the New EU MDR Medical Device Regulation 2017/745 is in place. One of its objectives has been improving the safety of users and patients. And one way to achieve that objective is ensuring that all the parties involved in the supply chain have clear roles and responsibilities.
In this article, we break down what each “economic operator” is responsible for.
1. The manufacturer (whether in the EU or outside the EU)
First, who is considered the manufacturer in the new EU MDR?
- An entity that manufactures or fully refurbishes a device;
- A trading company that subcontracts the manufacturing or refurbishment to another party;
- Other operators in certain cases (more on that below).
What does the manufacturer have to do?
- Create a system for risk management (if possible, following ISO 14971)
- Conduct a clinical evaluation of the products (to validate the effectiveness and safety of the device)
- Create the technical documentation of the device
- Write a declaration of conformity
- Set up and follow a Unique Device Identification system (UDI)
- Implement a quality management system, based on ISO 13485 (even though the EU MDR does not state so, it is rather obvious)
- Have a person responsible for regulatory compliance (the ‘PRRC’) on call – more the PRRC below
- Communicate well with other operators (tell distributor, or the importer & the EU rep, if there is an issue
- Be registered in the EUDAMED database (the modules of that IT system are being rolled out)
The obligations of manufacturers can apply to distributors, importers, or other entities if they do any of the following:
- Put the product under their own name;
- Change the intended purpose of a device that is already on the market;
- Modifies a device that is already on the market.
Under certain conditions, some activities are excluded from the modifications that lead to bearing the manufacturer’s obligations:
- Repackaging
- Translating
- Putting a logo as proof of repackaging and translation
2. The importer, for devices coming from outside the EU
The importer is based in the EU and places a device from a country outside the EU on the EU market.
Importers are audited by their country’s competent authority. Their responsibilities are listed below:
- Verify the declaration of conformity, and verify that the medical device is CE marked
- Verify that the manufacturer has appointed an EU authorized representative (more on that below)
- Verify the labelling (including UDI, for which there is a transition period) is compliant
- Verify that the product is registered in the EUDAMED database
- Register as an importer with EUDAMED
- Ensure storage and transportation don’t cause any issues
- Collect data about all nonconformances
- If there are serious issues, the importer must say no to importing the devices
3. The EU “authorized representative”, for devices imported from outside the EU
If the manufacturer is outside the EU, the manufacturer must give a mandate to an authorized representative, which can be a company or person.
The authorized representative must ensure the manufacturer complies with the MD Regulation (it has to approve the documents and keep them on file) and performs the tasks the manufacturer has to do under MDR.
If a problem is found, the authorized representative needs to cooperate with the authorities. And it must declare to authorities if there is an issue with the product.
The names of both the authorized representative (if the medical devices are imported from outside the EU) and the manufacturer have to be on the product.
4. The distributor in the EU
There might be a number of distributors. Any entity that makes the device available on the market, up to the point of putting it in service, is considered a distributor.
They get the devices from the manufacturer (via the importer if a manufacturer is outside the EU), from a company the combines packs, or from a company that sterilizes devices.
The distributor must verify:
- The labeling and the UDI (more on the UDI on this page)
- The CE mark
- The declaration of conformity
- That the storage of the devices will not lead to issues
They must collect complaints and feed them back to the manufacturer (if it is in the EU) or both the importer & the EU representative (if manufacturing is outside the EU).
5. The “procedure pack and system provider”
To simplify, this operator combines/assembles/packs several devices that are already CE marked. It is based in the EU.
The provider must ensure that:
- The devices are CE marked for the intended purpose
- The combined product is compatible with one intended purpose
- The devices are compatible with the manufacturer’s instruction
- The combination is verified and validated (does it works? is it safe?) by appropriate methods of internal monitoring
The provider must write a statement and provide relevant information to end-users.
In case the provider sterilizes the pack of systems, it must maintain a quality management system (again, based on ISO 13485), and it will be audited by the notified body.
6. The person responsible for regulation compliance (PRRC)*
*(This is technically not an economic operator.)
The manufacturer must have a PRRC, which can be a consultant (for a small manufacturer only) or an employee, within their organization.
The PRRC must possess the “requisite expertise in the field of medical devices”, such as a diploma or certificate as well as relevant experience.
The EU authorized representative also needs to have a PRRC (and it cannot be the same as that of the manufacturer).
The PRRC has to be independent within the organization (no conflict of interest, no disadvantage in doing their work) and can perform his/her duties without obstacles.
The PRRC must:
- Ensure compliance with the EU MDR
- Prepare technical documentation as well as the declaration of conformity, and keep them on record
- Ensure post-market surveillance and vigilance reporting do take place
See guidance on this page for more details about the PRRC.
Learn more about the new EU MDR here
Listen to this recent podcast episode where product compliance expert Clive Greenwood joined us to discuss how the EU MDR is a revolutionary new compliance regulation that will clean up the medical device industry (and will have an impact on other industries in time, too):
Read even more information about the EU Medical Device Regulation:
- EU MDR Changes: Are You Selling a Medical Device, and What Class Is It?
- EU MDR Update: How To Get a New Medical Device Certified? [Flow Charts]
A disclaimer…
We at Sofeast are not lawyers. What we wrote above is based only on our understanding of the regulatory requirements. We do not present this information as a basis for you to make decisions, and we do not accept any liability if you do so. Please consult a lawyer before taking action.
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