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Swiss Authorized Representative
Why You Need a Swiss Authorized Rep
Switzerland was never a member of the EU, but in the interest of ensuring a smooth flow of goods across borders, it has traditionally signed Mutual Recognition Agreements (MRA) with the EU. When the EU Medical Device Regulation (MDR) took effect, an agreement to renew the medical device MRA was not reached. Without an MRA, Switzerland became a “third country” to the EU. As such medical device and IVD manufacturers without a registered office in Switzerland must now appoint a local Swiss Authorized Representative and Swiss Importer. With a registered office in Switzerland, MedEnvoy offers these services to manufacturers.
MedEnvoy can act as your importer in the EU, UK and Switzerland!
Swiss Authorized Rep Responsibilities
As your Swiss CH-REP, we perform many of the same responsibilities as an EU Authorized Representative. Shown below are some of our mandated legal obligations:
- Check to ensure that devices have been registered with Swissmedic
- Verify the presence of a Declaration of Conformity and technical documentation
- Verify that the correct conformity assessment procedure has been performed
- Ensure that labelling and IFU are compliant and that UDI has been assigned
- Maintain a register of complaints
- Inform the manufacturer if the device poses a serious risk or does not comply with MedDO
- Report to Swissmedic regarding serious incidents or risks
- Cooperate with Swissmedic regarding preventative/corrective action
And more!
How the CH-REP Process Works
MedEnvoy has developed a process that prevents duplication of efforts with your Swiss distributor(s) and importer. We utilize technology to streamline the review and approval of your documentation and other Swissmedic obligations.
For maximum efficiency, we will work with you to develop contractual arrangements and QMS procedures to prevent redundant activities from being performed while ensuring your compliance with Swiss regulations.
Responsibilities specific to the CH-REP will be supported by procedures and work instructions that MedEnvoy will co-develop with you during the onboarding process. This will ensure speedy compliance checks and an uninterrupted flow of product shipments into Switzerland.
Have a subsidiary in Switzerland?
Manufacturers with established legal entities in Switzerland can designate that entity as their Importer. MedEnvoy can provide “white label” back office services to your Swiss subsidiary to ensure all Swiss MedDO importer obligations are met. Your subsidiary name goes on your labelling as an importer!
Deadlines for choosing a Swiss Authorized Representative
You are required to appoint a CH-REP by the deadlines shown below. Because it can take several months to modify your labelling, review/sign contracts and register with Swissmedic, we strongly recommend selecting your Swiss CH-REP early enough to ensure an uninterrupted flow of shipments into Switzerland. A reasonable lead time is 4-6 months. MedEnvoy can help ensure you meet these deadlines with time to spare.
Class IIb, Class III & active implantable:
December 31, 2021
Class IIa & Class IIb non-implantable:
March 31, 2022
Class I & system/procedure packs:
July 31, 2022
In-country AR Fee structure
Our Authorized Representation services are provided for a flat annual fee, regardless of the number of devices.
- Technical File review fee (one time)
- Annual representation fee
NOTE: If you also work with MedEnvoy as your Importer, we can offer a multi-service discount.