Request a quote for
Swiss Authorised Representative (CH-REP)

First of all we need to know some of your information.

Company and contact person

Company*This field is required

Full name (first & last name)*This field is required

Job title*This field is required

Phone number*This field is required

Email address*This field is required

Company particulars

Country*This field is required

Website*This field is required

Person Responsible for Regulatory Compliance, PRRCThis field is required

Product information

We need to know how many Technical Files/Documentation sets and how many GMDN codes (or EMDN codes) you have.

Number of Technical Files/Documentation sets*This field is required

Number of GMDN codes

MDD/MDR Class I / IVDD Self-Decl. (Non-annex II) / IVDR Class A*

MDD/MDR Class Is,Ir, Im*

MDD/MDR Class IIa / IVDR Class B*

MDD/MDR Class IIb / IVDD List B / IVDR Class C*

MDD/MDR Class III / IVDD List A / IVDR Class D*

EU/EC declaration of conformity* (max size 10mb)

Labeling* (max size 10mb)

Please note:

Requesting a quote does not imply acceptance of the mandate. Due to high demand, we prioritize existing customer connections.
The Swiss Authorised Representative, i.e. Decomplix, is jointly and severally liable with the manufacturer for defective devices. Therefore, Decomplix verifies the conformity of the medical device and reviews the technical documentation of its product before accepting the mandate. Only after completion of this procedure, Decomplix will make the final decision for acceptance.

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