Request a quote for
Swiss Authorised Representative

(For CE marking request please switch to the CE marking contact form.)

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

Company and contact person

Company*This field is required

Full name (first name & family 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

Class I medical devices /IVD list/class A*

Class Is/Ir/Im medical devices / IVD list/class A*

Class IIa medical devices /IVD list/class B**

Class IIb medical devices / IVD list/class C**

Class III medical devices / IVD list/class D* (please note that Decomplix only offers Swiss Representative services for Class III medical devices / IVD list/class D on a case-by-case basis)

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

Labeling* (max size 10mb)

Please note:

Decomplix cannot guarantee acceptance of the mandate. Because the Swiss Authorised Representative is jointly and severally liable with the manufacturer for defective products, Decomplix subjects the acceptance of the CH-REP mandate to a preliminary verification of compliance of the medical devices, which encompasses the review of its technical documentation.
Decomplix cannot guarantee to take over the mandate, as regular clients have priority.

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