One of our aims here at Shiro is to help medical device and MedTech companies comply with EU, Swiss and UK regulations. With this in mind, we wanted to ensure you knew of the upcoming deadline to appoint a CH-REP for Class I and system/procedure pack updates for medical devices.
We notified you about the SwissMedic guidance in our recent blog post, “Deadline to appoint a CH-REP for Class 1 & System/Procedure packs is approaching“, and pointed out that if medical device and MedTech manufacturers wanted to continue placing their devices on the market in Switzerland, then you needed to ensure you had appointed a CH-REP by 31st July 2022.
This date is important, as it is the date when it becomes mandatory for Class I MDR devices to include CH-REP information on the label. This may sound straightforward, but our experience shows that labelling updates can be more time-consuming and complex than they first appear.
Therefore, if you have devices you want to place on the Swiss market, it is better to start preparing for this change now rather than wait until nearer the time.
Shiro Business Solutions work closely with MedEnvoy – the largest provider of Swiss Authorised Representative (CH-REP) and Swiss importer services. We are both here to support you in complying with these regulatory changes as efficiently as possible, so please don’t hesitate to get in touch if you have any questions or require any other assistance.