January 12, 2023

Swissmedic Implements MDCG 2022-18 to Deal with MDR Certification Gaps

Switzerland announced it will implement MDCG 2022-18, to deal with MDR certification gaps under MDR Article 97. Find out the requirements and how to comply.
January 4, 2023

Switzerland: 2022 Recap & 2023 Look Forward

Find out what regulatory news you may have missed from Swissmedic in 2022, and the upcoming 2023 deadlines for medical devices & IVDs in Switzerland.
December 1, 2022

Class D IVD Deadline to Appoint Swiss Authorized Rep: 31 Dec 2022

Manufacturers of Class D IVDs must appoint a Swiss Authorized Representative by 31 December 2022. This is required even if the device is CE Marked to the IVDD.
November 28, 2022

Swiss Parliament Votes to Accept US FDA Devices

Today Swiss Parliament voted to allow FDA approved devices onto the Switzerland market, in addition to European CE marked devices. Read here to find out more.
November 18, 2022

Swissmedic Seminar on IvDO/IVDR

Swissmedic hosted a seminar on the new IVD Ordinance in Switzerland. Read about the current situation with Europe, the IVDR, registration requirements & more.
September 13, 2022

Update: Switzerland Registration Database (Swissdamed)

Swissmedic published an update regarding its registration database: the Swiss Database on Medical Devices (Swissdamed). Find out when it will be released and who has to comply.
July 1, 2022

Approaching Deadline: Appoint Swiss Authorized Rep for Class I & System/Procedure Packs

The deadline to appoint a Swiss Authorized Representative for Class I devices and System/Procedure Packs is quickly approaching. Find out how Casus can help ...
May 26, 2022

IVDR Round-Up: EU, Switzerland and UK

There is extensive activity surrounding the IVDR’s date of implementation today. Here we will discuss what is new, and the impact in the EU, Switzerland, and the UK ...
May 9, 2022

CONFIRMED: Switzerland adopts IvDO/IVDR

It’s official. Swissmedic will adopt the IvDO, which heavily references the IVDR. On 4 May 2022 Swissmedic updated its website to state that the “provisions of the EU IVDR were transferred to a new Swiss ...