The deadline for appointing a Swiss Authorised Representative (CH-REP) for Class 1 Devices, and System/Procedure Packs is fast approaching.
The legislation states that if medical device manufacturers want to continue placing their devices on the Swiss market, they must appoint their CH-REP by 31 July 2022.
By this point, your medical device labelling must include the name and address of your CH-REP. With this in mind, Swissmedic has released a CH-REP symbol to be used on the packaging – similar to how the EC-REP symbol is used.
Why does Swissmedic now require you to have a CH-REP?
Switzerland is not part of the EU, but they have traditionally had agreements with the EU to allow for a smooth flow of goods across EU borders. These agreements are called the Mutual Recognition Agreements (MRAs) and allow manufacturers from Switzerland and European countries to sell across their borders without the need to comply with the rules that may apply to so-called “third countries.”
However, EU and Swiss legislators could not agree on other specific issues, and they reached no actual agreement relating to the import/export of medical devices before the EU MDR came into effect in May 2021. This lack of accord led to Switzerland becoming very much like the UK regarding medical devices.
As there was no MRA in place, all medical device manufacturers outside of Switzerland, even those who are EU based, now have to register their company and the devices they produce in Switzerland AND appoint a Swiss Authorised Representative (CH-REP). There are deadlines associated with this, two of which have already passed and one fast approaching.
- The deadline for appointing a CH-REP for Class IIb, Class III and active implantable devices was 31 December 2021
- The deadline for appointing a CH-REP for Class IIa, and Class IIb non-implantable devices was 31 March 2022
- The deadline for appointing a CH-REP for Class I and System/Procedure Packs is 31 July 2022
Do I need to appoint anyone else besides a CH-REP to sell my medical device in Switzerland?
Ideally, yes, you do. As well as appointing a CH-REP, there is a requirement for a CH-Importer. If you do not appoint an independent Importer for Switzerland, this role, by default falls upon your customer. This means that they are required to meet all of the obligations of the MedDO and take legal liability and responsibility for 1st placement of the product on the Swiss market. Not an ideal situation for your customers.
The Swiss importer has a critical role in helping ensure you comply with the Swiss Medical Devices Ordinance (MedDO) rather than dealing with the logistics side of things.
The legal obligations associated with a Swiss importer include:
- Ensuring the device is labelled according to Swiss MedDO requirements, including a listing of the importer
- Maintaining a copy of the Declaration of Conformity and relevant certificates
- Verifying that a tri-lingual IFU exists
- Verifying UDIs have been assigned
- Informing manufacturers, distributors and CH-REP about complaints, field actions etc.
- Maintaining a register to ensure that non-compliant products are not sold in Switzerland.
- Telling Swissmedic if the importer believes the device does not comply with MedDO
- Checking that storage and transportation conditions are suitable for the products
- Cooperating with Swissmedic as required
How can Shiro Business Solutions help you comply with the new regulations?
Shiro Business Solutions work closely with MedEnvoy – the largest provider of Swiss Authorised Representative (CH-REP) and Swiss importer services. We are ideally placed to help you ensure you are complying with the Swiss MedDO regulations.