This article presents an overview of different stakeholders and the concept of the economical operators in relation to the MDR. The following video, which is a part of our online course Introduction to the Medical Device Regulation (EU) 2017/745, explains the topic in-depth.
The MDR defines different stakeholders, and different requirements apply to the different stakeholders, depending on the type of work they do.
The European Commission (EC) is the executive branch of the European Union and it is responsible for enforcing EU laws, directing the EU’s administrative operations, and proposing legislation. Any adopted and published legislation, like the MDR, needs to be implemented in all the EU member states.
The Blue Guide explains how the European market is defined and governed. It also includes explanations on terms like “placing on the market” and “putting into service”.
The manufacturer is the main stakeholder and represents an economical operator as well. This does not mean, however, that the manufacturer is the one and only stakeholder or economical operator concerning the Medical Device Regulation.
The manufacturer or sometimes called the legal manufacturer is the natural or legal person responsible for the actual medical device before and after placing it on the market. They assure compliance to the MDR by applying the CE mark to their products.
While it is an interesting fact that there is no documented definition of a competent authority in the MDR, nevertheless, it shall be understood as the part of a country’s authority (or authorities) that has been pointed out in the different national laws as being responsible for medical devices in that member state.
The notified bodies are another stakeholder. Those are the companies designated by a competent authority in a member state that assist the authorities in controlling the European market access for manufacturers of medical devices, excluding the manufacturers of pure Class I devices.
Authorised representative, known as the EC-REP is a European operator appointed by a medical device manufacturer outside the European Union to act in their name regarding specific European requirements. The EC-REP symbol may be found on the label of a medical device, and it indicates who is the European authorised representative.
Since the manufacturers outside the European Union need the authorised representative, they also need a defined importer. An importer is a European operator that imports medical devices from a non-European manufacturer and takes on some responsibilities regarding those devices. It is essential to know that the importer and the EC-REP can be the same or different operators.
A distributor is an operator that essentially sells the medical devices to the users or retailers. The MDR defines a distributor as
“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.”
MDR, Article 2 (34)
A health institution is an organisation with the primary purpose of the care or treatment of patients or the promotion of public health. Health institutions are also affected by some requirements in the MDR such as custom-made devices, potential re-processing or re-sterilisation of medical devices and some requirements for traceability, in special cases.
Another stakeholder is the patient. In MDR there is no definition of a patient, but according to the MDR, ‘user’ is any healthcare professional or layperson who uses a device, so the patient is then the person receiving the treatment of the medical device. So, everyone can basically be a user or a patient.
Some of the stakeholders are defined as economic operators, according to the MDR. This is important to remember and grasp since economic operators are referenced quite frequently in the MDR and have specific requirements to fulfil. The economic operators are:
It is noticeable that the competent authorities, notified bodies, and health institutions are not considered economic operators and, of course, the users and patients are not either.
In conclusion, every stakeholder within the MDR has their own roles to fulfil, and in the medical device industry, it is of great importance to know exactly what those roles are, as is to know the difference between the stakeholders and economic operators.
If you found this article helpful, make sure you read through the others as well here.
If you want to know more about understanding the European regulation for medical devices, take a look at our online Introduction to the Medical Device Regulation (EU) 2017/745 course. This online course is an in-depth overview of the Medical Device Regulation according to (EU) 2017/745 as well as related guidances, like MDCG, and how to apply to a notified body for conformity assessment.
It is suitable for anyone working with regulatory questions, such as RA and QA engineers, PRRC or management.
Pontus Gedda is a dedicated medical device specialist that has worked both in the industry, as a design engineer and project manager, and in the notified body world as a medical device lead auditor and manager.
He has vast experience in the MDR and its implementation thru hands-on experience from implementing the MDR at a notified body and leading that notified body through a joint assessment and getting designated as an MDR notified body.
He was a senior manager at a notified body during the transition from MDD to MDR and also a member of the NB-MED group.
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