Roles and Responsibilities Authorized Representative

The roles and responsibilities according to European Directives

 Role and responsibilities
 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


The roles and responsibilities according to European Regulations

 Role and responsibilities
 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


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