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

Click here for more information about our EC-REP services in general

Contact us for more information
*
*
*
*
*
Submit

QARAD B.V.B.A.

Headquarters
Pas 257, 2440 Geel
BELGIUM
Tel.: +32 (0)14 49 04 22
Mail.: info@qarad.com

ISO 13485 Certified

Follow us on:

Quicklinks

Website by • Contents by Qarad • Terms and conditions  • Privacy policy  • Cookie policy  •
Close

Attention!

This website uses cookies to enhance your surfing experience.
Certain webfunctions rely on the usage of these cookies.
If you want more information regarding our cookie policy, you may visit this link.