Roles and responsibilities of the EC-REP

If you want to sell your product in other countries than your own, it is important to take into account the local regulations. Many countries require so-called “third country manufacturers” to appoint an Authorised Representative before they can sell their products in the respective country.

Manufacturers of in vitro diagnostics, medical devices and active implantable medical devices who do not have a registered place of business in a Member State of the EU or EFTA, nor in Switzerland or Turkey, need to appoint an Authorized Representative or EC-REP.

Qarad can act as your EC-REP to facilitate your product’s access on the European market.

The exact roles and responsibilities of an Authorized Representative are clearly defined in the different Directives and Regulations.

According to the European Directives

IVDD 98/79/EC

MDD 93/42/EEC

AIMD 90/385/EEC

Acts and may be addressed by authorities in the EU instead of the manufacturer with regard to the latter’s obligations under the Directive

Art. 1.2

Art. 1.2

Art. 1.2

Notifies the Competent Authorities of the address of the manufacturer

Art. 10

Art. 14

Art. 10a

Notifies the Competent Authorities of the manufacturer’s products

Art. 10

Art. 14

Art. 10a

Notifies the Competent Authorities of changes to the products

Art. 10

Art. 14

Art. 10a

Notifies the Competent Authorities of performance characteristics (Annex II IVD products and devices of self-testing only)

Art. 10

Draws up the statement concerning devices for performance evaluation

Annex VIII

May be contacted by the Commission in the context of the Safeguard Clause

Art. 8

Art. 8

May initiate Conformity Assessment Procedures

Art. 9.6

Art. 11.8

Art. 9.3

Must make technical documentation available to authorities on their request

Art. 9.7

Annex III.7

Annex II.6.1

Is informed by Competent Authorities about incidents

Art. 11

Art. 10

Art. 8

May be the interface between Notified Body and manufacturer

Art. 15

Art. 16

Art. 11

In the case of a wrongly affixed CE mark, the Authorized Representative must bring the infringement to an end

Art. 17

Art. 18

Art. 13a

For devices intended for clinical investigations, the Authorized Representative follows the required procedure and notifies the Competent Authorities

Art. 15.1

Art. 10.1

According to the European Regulations

IVDR 2017/746

MDR 2017/745

Acts on behalf of the manufacturer    

Art. 2.25

Art. 2.32

Provide a copy of the Manufacturer’s mandate to appoint its EC-REP to the competent authority upon request

Art. 11.3

Art. 11.3

Verify that the EU Declaration of Conformity and Technical Documentation have been drawn up

Art. 11.3a

Art. 11.3a

Where applicable, verify that an appropriate conformity assessment procedure has been carried out by the manufacturer

Art. 11.3a

Art. 11.3a

Keep a copy of Technical Documentation, Declaration of Conformity and, if applicable, a copy of a relevant certificate at the disposal of competent authorities

Art. 11.3b

Art. 11.3b

Comply with the registration obligations

Art. 11.3c

Art. 28

Art. 11.3c

Art. 31

Verify compliance of Manufacturer’s registrations obligations

Art. 11.3c

Art. 26

Art. 11.3c

Art. 27

Art. 29

Provide the competent authority with information and documentation necessary to demonstrate the conformity of a device upon request

Art. 11.3d

Art. 11.3d

Forward to the manufacturer any request by a competent authority for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device

Art. 11.3e

Art. 11.3e

Cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices

Art. 11.3f

Art. 11.3f

Inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated

Art. 11.3g

Art. 11.3g

Shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer

Art. 11.5

Art. 11.5

According to the European Directives

Acts and may be addressed by authorities in the EU instead of the manufacturer with regard to the latter’s obligations under the Directive: Art. 1.2

Notifies the Competent Authorities of the address of the manufacturer: Art. 10

Notifies the Competent Authorities of the manufacturer’s products: Art. 10

Notifies the Competent Authorities of changes to the products: Art. 10

Notifies the Competent Authorities of performance characteristics (Annex II IVD products and devices of self-testing only): Art. 10

Draws up the statement concerning devices for performance evaluation: Annex VIII

May be contacted by the Commission in the context of the Safeguard Clause: Art. 8

May initiate Conformity Assessment Procedures: Art. 9.6

Must make technical documentation available to authorities on their request: Art. 9.7

Is informed by Competent Authorities about incidents: Art. 11

May be the interface between Notified Body and manufacturer: Art. 15

In the case of a wrongly affixed CE mark, the Authorized Representative must bring the infringement to an end: Art. 17

Acts and may be addressed by authorities in the EU instead of the manufacturer with regard to the latter’s obligations under the Directive: Art. 1.2

Notifies the Competent Authorities of the address of the manufacturer: Art. 14

Notifies the Competent Authorities of the manufacturer’s products: Art. 14

Notifies the Competent Authorities of changes to the products: Art. 14

May be contacted by the Commission in the context of the Safeguard Clause: Art. 8

May initiate Conformity Assessment Procedures: Art. 11.8

Must make technical documentation available to authorities on their request: Annex III.7

Is informed by Competent Authorities about incidents: Art. 10

May be the interface between Notified Body and manufacturer: Art. 16

In the case of a wrongly affixed CE mark, the Authorized Representative must bring the infringement to an end: Art. 18

For devices intended for clinical investigations, the Authorized Representative follows the required procedure and notifies the Competent Authorities: Art. 15.1

Acts and may be addressed by authorities in the EU instead of the manufacturer with regard to the latter’s obligations under the Directive: Art. 1.2

Notifies the Competent Authorities of the address of the manufacturer: Art. 10a

Notifies the Competent Authorities of the manufacturer’s products: Art. 10a

Notifies the Competent Authorities of changes to the products: Art. 10a

May initiate Conformity Assessment Procedures: Art. 9.3

Must make technical documentation available to authorities on their request: Annex II.6.1

Is informed by Competent Authorities about incidents: Art. 8

May be the interface between Notified Body and manufacturer: Art. 11

In the case of a wrongly affixed CE mark, the Authorized Representative must bring the infringement to an end: Art. 13a

For devices intended for clinical investigations, the Authorized Representative follows the required procedure and notifies the Competent Authorities: Art. 10.1

According to the European Regulations

Acts on behalf of the manufacturer: Art. 2.25

Provide a copy of the Manufacturer’s mandate to appoint its EC-REP to the competent authority upon request: Art. 11.3

Verify that the EU Declaration of Conformity and Technical Documentation have been drawn up: Art. 11.3a

Where applicable, verify that an appropriate conformity assessment procedure has been carried out by the manufacturer: Art. 11.3a

Keep a copy of Technical Documentation, Declaration of Conformity and, if applicable, a copy of a relevant certificate at the disposal of competent authorities: Art. 11.3b

Comply with the registration obligations: Art. 11.3c Art. 28

Verify compliance of Manufacturer’s registrations obligations: Art. 11.3c Art. 26

Provide the competent authority with information and documentation necessary to demonstrate the conformity of a device upon request: Art. 11.3d

Forward to the manufacturer any request by a competent authority for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device: Art. 11.3e

Cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices: Art. 11.3f

Inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated: Art. 11.3g

Shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer: Art. 11.5

Acts on behalf of the manufacturer: Art. 2.32

Provide a copy of the Manufacturer’s mandate to appoint its EC-REP to the competent authority upon request: Art. 11.3

Verify that the EU Declaration of Conformity and Technical Documentation have been drawn up: Art. 11.3a

Where applicable, verify that an appropriate conformity assessment procedure has been carried out by the manufacturer: Art. 11.3a

Keep a copy of Technical Documentation, Declaration of Conformity and, if applicable, a copy of a relevant certificate at the disposal of competent authorities: Art. 11.3b

Comply with the registration obligations: Art. 11.3c Art. 31

Verify compliance of Manufacturer’s registrations obligations: Art. 11.3c Art. 27 Art. 29

Provide the competent authority with information and documentation necessary to demonstrate the conformity of a device upon request: Art. 11.3d

Forward to the manufacturer any request by a competent authority for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device: Art. 11.3e

Cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices: Art. 11.3f

Inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated: Art. 11.3g

Shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer: Art. 11.5

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