CH-REP
CH REP
Swiss Authorised Representative
for Medical Devices
CH REP
Swiss Authorised Representative
for Medical Devices
Responsible person in the Swiss market
Who is a Swiss Medical Device Representative?
Who is a Swiss Medical Device Representative?
A Swiss authorised representative is
any natural or legal person established on Swiss soil who is responsible for acting on behalf of the manufacturer
to assist it at the regulatory level in the Swiss market.
Switzerland
has never been a member of the European Union, but in the interest of ensuring a smooth bilateral flow of goods across borders, it has traditionally signed Mutual Recognition Agreements (MRAs) with the EU.
When the EU Medical Device Regulation (MDR) came into force, no agreement had been reached to renew the MRA on medical devices.
Although the Swiss had updated their Medical Device Ordinance (MepV, MedDO) to diligently copy the MDR, without an MRA, Switzerland became an EU "third country" just like the UK.
Therefore, medical device and IVD manufacturers without a registered office in Switzerland must now appoint a local Swiss authorized representative and a Swiss importer
to continue selling in Switzerland.
Swiss Specialised Representative for Medical Devices
Swiss Specialised Representative for Medical Devices
Mdq Services Ltd as authorized representative for Switzerland
offers the following services:
- we will advise on labeling changes to comply with MedDO requirements;
- we will review your labeling to ensure compliance;
- meet the supervision and incident reporting requirements of Swiss ARs;
- if reportable events occur in Switzerland, cooperate with Swissmedic as required by law;
- verification of the Declaration of Conformity and technical documentation;
- verification that the correct conformity assessment procedure has been carried out;
- verification of labeling and accompanying information (IFU);
- Verification that the UDI has been assigned;
- verification that the manufacturer is correctly identified;
- verifies that storage and transportation requirements are met;
- we will maintain a complaint log as required by law;
- we will inform the manufacturer if the device presents a serious risk/non-compliant;
- we will verify that the devices have been registered with Swissmedic;
- report serious incidents or risks to Swissmedic;
- collaborate with Swissmedic on preventive/corrective actions;
- we will verify the identification of devices within the supply chain.
Deadlines for appointing Swiss CH-REP
Deadlines for appointing Swiss CH-REP
Listed below are the upcoming deadlines for appointment of the Swiss Medical Device Representative:
- Class IIb, Class III and active implantable devices: Swiss AR required by December 31, 2021;
- Class IIa, Class IIb non-implantable devices: Swiss AR required by March 31, 2022;
- Class I devices and procedural systems/kits: Swiss AR required by July 31, 2022.
MDQ's services as CH REP are set up:
MDQ's services as CH REP are set up:
Custom made
Custom made
The role of AR needs an annual fee for the responsabilities
of the role. The fee is set up on the company dimension and number of product families.
Every activity is then explained in an accurate price quotation.
Performance
Performance
Post market analysis and reporting. The importance of monitoring perfomance is recognised, we know where to find the information.
Compliant
Compliant
One of our qualified Engineer will take care of the conformity of your products. Devices conformity will adequately check in accordance with the MDR requirements.
Small package
Small package
Designed specifically for micro entrprises*: it contains the annual fee and the basic activities designed for small business
Medium package
Medium package
Designed specifically for small companies*: it contains the annual fee and the basic activities designed for medium business
Large package
Large package
Designed specifically for large companies*: it contains the annual fee and the basic activities designed for big companies
*in accordance with Commission Recommendation 2003/361/EC.
Looking for a CH-REP for Medical Devices?
We’re here to help!
Looking for a CH-REP for Medical Devices?
We’re here to help!
We want to know your needs exactly so that we can provide the perfect solution. Let us know what you want and we’ll do our best to help.