Be advised that a business may have several of the roles depending on which activities they perform. For example, a manufacturer may have a manufacturer role for the device they manufacture themselves, and a distributor role for other medical devices they sell together with their own devices.
Overview of the different roles of economic operators:
Manufacturer
| 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.
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Authorised representative
| Any natural or legal person established within the 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 this Regulation.
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Importer
| Any natural or legal person established within the Union* that places a device from a third country on the Union* market.
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Distributor
| 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 into service.
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Health institution
| An organisation the primary purpose of which is the care or treatment of patients or the promotion of public health.
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*«Union» in this context means countries in the EU/EEA and Turkey.
Figure: Economic operators in the supply chain.
General obligations for manufacturers of medical devices
The table below lists some of the requirements, but the list is not exhaustive. The requirements that are relevant for each individual manufacturer also depend on the type of medical device and the device's risk classification. The requirements and obligations of manufacturers are found in several parts of MDR and IVDR and it is important that manufacturers familiarise themselves with the entire regulations.
MDR Article 10
IVDR Article 10
| General obligations for:
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Risk management system
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Clinical evaluation (MDR) / performance evaluation (IVDR)
- Technical documentation
- Conformity assessment, EU declaration of conformity and CE marking of conformity
- Unique Device Identification (UDI)
- Registration of device and manufacturer
- Storage time of documentation
- Availability and providing of documentation
- Quality management system
- System for monitoring after the device has been placed on the market
- Implementation of corrective measures
- Notification of devices on the market that do not comply with the regulations
- System for recording and reporting of incidents and field safety corrective actions
- Registration of original manufacturer if the manufacturer has their device designed or manufactured by another enterprise
- Insurance / coverage for damage caused by the manufacturer's device
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MDR Article 11
IVDR Article 11
| Requirement for an authorised representative for manufactureres outside the EU/EEA or Turkey
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MDR Article 15
IVDR Article 15
| Requirement for a person responsible for regulatory compliance
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MDR Article 18
| Requirements for patient information and implant cards for implantable medical devices
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MDR Article 22
| Requirements for systems and procedure packs
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MDR Article 29
IVDR Article 26
| Requirements for registration of devices
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MDR Article 31
IVDR Article 28
| Requirements for registration of manufacturers and single registration number
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MDR Article 32
IVDR Article 29
| Requirements for summary of safety and clinical performance
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General obligations for authorised representatives of medical devices
The table below lists some of the requirements, but the list is not exhaustive. Requirements and obligations for authorised representatives are found in several parts of MDR and IVDR and it is important that authorised representatives familiarise themselves with the entire regulations.
MDR Article 11
IVDR Article 11
| General requirements for:
- Mandate from the manufacturer
- Control of
- EU Declaration of conformity
- Technical documentation
- The conformity assessment procedure
- The manufacturer’s registration and UDI
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Cooperate with the competent authorities by
- Make documentation available
- Assist in making devices or samples available
- Implement preventive or corrective measures
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Registration of an authorised representative
- Inform the manufacturer immediately about complaints and reports of incidents
- If the manufacturer acts contrary of its obligations
- Terminate the mandate with the manufacturer
- Inform the Norwegian Medicines Agency and the notified body
An authorised representative, together with the manufacturer, is legally responsible for defective devices. |
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MDR Article 11
IVDR Article 11
| Requirements for replacing an authorised representative
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MDR Article 15
IVDR Article 15
| Requirement for person responsible for regulatory compliance
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MDR Article 31
IVDR Article 28
| Requirements for registration of authorised representatives and single registration number
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MDR Article 95
IVDR Article 90
| Requirement for procedure for dealing with devices presenting an unacceptable risk to health and safety
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General obligations for importers and distributors of medical devices
In the table below some of the obligations for importers and distributors are listed. The list is not complete. Requirements and obligations for economic operators are found several places in MDR and IVDR. It is important that importers and distributors familiarize themselves with all the regulations that are relevant to their role.
| MDR article13 and 14 IVDR article13 and 14
| Obligations for control of:- Manufacturer
- Authorised representative
- Registration of devices
| ü
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| Obligations for control of:
- Declaration of Conformity
- CE marking of Conformity
- Labelling and instruction for use
- UDI-code
| ü | ü
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| Indicate on the device, packaging or accompanying document: - Importers name and adress.
| ü
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| Verify that the device, packaging or accompanying document identify: - Importers name and adress.
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| If the device is not in conformity with the regulations: - Withdraw or recall
- Inform manufacturer, authorised representative and importer
- Inform the Norwegian Medicines Agency if the device presents a serious risk or is a falsified
| ü
| ü
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| Ensure that a register is kept of complaints, of non-conforming devices and of recalls and withdrawals.
| ü
| ü
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| | Ensure that information regarding complaints, of non-conforming devices and of recalls and withdrawals are passed on.
| ü
| ü
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| | Ensure that necessary corrective actions are taken.
| ü
| ü
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| | Ensure proper storage and transport conditions of the device.
| ü | ü
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| MDR article 25 IVDR article 22
| Ensure identification of the device within the supply chain.
| ü
| ü
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| MDR article 27 IVDR article 24
| Ensure to store and keep the UDI for devices where relevant.
| ü
| ü
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| MDR artikkel 30 IVDR artikkel 27
| Verify that manufacturer or authorised representative within two weeks of placing a device have been registered.
| ü
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| MDR article 31 IVDR article 28
| Registration of importer.
| ü
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General obligations for health institutions when using medical devices
Identification within the supply chain
Health institutions shall store and keep preferably by electronic means the UDI of the devices which they have supplied or with which they have been supplied, if those devices belong to class III implantable devices.
It is important that health institutions establish good systems and routines for traceability of all types of medical devices to make advantage of the opportunities of the UDI-system.
For further details, see MDR article 27 point 9.
«In-house» manufactured medical devices/ the exception
The regulations allow health institutions to produce, modify and use medical devices used only within health institutions in order to meet specific patient group’s specific needs, where such needs cannot be met at an appropriate level of performance by an equivalent device available on the market. Specific conditions are set for this type of manufacturing of medical devices.
For further details see MDR article 5 and IVDR article 5
Read more about in-house-manufactured medical devices (in Norwegian)
Reprocessing of single-use devices not permitted
From 1th January 2022 reprocessing of single-use devices in Norway is not permitted.
Conduct of a clinical investigation/performance study
Health institutions that sponsor or health professionals who participate in a clinical investigation or performance study, must be aware of their obligations.
For further details, see MDR article 72 Conduct of a clinical investigation and IVDR article 68 Conduct of a performance study.
Read more:
Clinical investigations of medical devices
Performance studies of in vitro diagnostic medical devices
