The Swiss Mutual Recognition Agreement (MRA) for medical devices between the EU and Switzerland has lapsed on May 26, 2021, and the negotiations between Switzerland and the EU have concluded without any concurrence on Institutional Agreement (InstA). Under the lapsed MRA between the EU and Switzerland, the requirements for medical devices defined under the Swiss Medical Device Ordinance (MedDO) were compliant with the EU MDD and EU AIMDD.
Since August 1, 2021, the revised MedDO is in effect and is compliant with the new EU Medical Device Regulation (MDR). The EU-based medical device manufacturers shall comply with the revised Medical Device Ordinance (MedDO). These companies shall appoint a Swiss Authorized Representative and the representative must have access to a copy of technical documentation or should be able to submit the documents within seven (07) days from the day as requested by the Swissmedic. The Swissmedic has provided transitional timelines for various device categories for appointing a Swiss Authorized Representative (AR), including the corresponding labeling. The transitional timeline for non-implantable Class IIb and IIa devices is fast approaching, and all the EU based manufacturers of these device classes have to appoint a Swiss AR by March 31, 2022.
It is essential to be aware of all these changes and what they mean to the medical device industry. How can the manufacturers align with the new regulations? Do you have a clear understanding of the following?
- Overview of Swixit and Swiss Medical Device Regulations
- Routes to Market in Switzerland
- Overview of Swiss AR and Roles
- PRRC - Roles and Responsibilities
- Labeling Requirements
- Key Implications
- Case Study
To help you understand the current practical considerations of the Swiss medical device industry, we bring you an exclusive live webinar on, “Swixit - Regulatory Impact for Medical Devices & Med Tech Industry”, scheduled on March 23, 2022, for AMR, EU, and RoW regions. In this webinar, our in-house Regulatory experts – Nisha Vempalle, Director - Medical Devices, and Dr. Ceren Alemdaroglu - Regulatory Affairs Specialist (PRRC), Medical Devices, will discuss the current updates on Swiss medical device regulations. The webinar will be hosted by Igor Dorosh, Associate Director - Business Development - Europe & Africa. Register now to book your place. Stay informed. Stay compliant.