Swissmedic now handles registration of economic operators, medical devices and In-vitro diagnostic medical devices directly, since the agreement on mutual recognition of conformity assessments (MRA) between Switzerland and the EU has not been updated.
Swissmedic has developed the “Swissdamed” database, an IT system for applying Swiss regulations on medical devices. It is structured around two interconnected modules, where only registered users can access. It also includes a freely accessible search function.
Release of Swissdamed Timeline
- Registration of companies and economic operators – ACT module (available early 2024)
- Swissdamed – freely accessible platform (available early 2024)
- Registration of devices – UDI module (available from summer 2024)
The above modules will be available in different releases.
Economic operators who register with Swiss medic prior to the launch of Swissdamed and have a CHRN are not necessary to re-register; they will only need to verify their information once it has been integrated into the new system.
Swissdamed will be rolled out in three releases. The registration of economic operators will be covered by the first release, and the registration of medical devices will be possible with the second release. Additional functionalities will be added to the already-implemented modules in the third and final release. Selected economic operators will be included by Swissmedic in the realisation phase.
Modules in Swissdamed Not Mandatory Yet
Registration on Swissdamed will only become compulsory when the relevant amendments are made to the MedDO / IvDO. Until the ordinances are amended, devices can be registered on the Swissdamed platform on a voluntary basis.
Since the Mutual Recognition Agreement (MRA) addressing conformity assessments between the country and the European Union has ended, medical device and In-vitro diagnostic (IVD) manufacturers must now comply with important regulatory compliance obligations in Switzerland.
The European Medical Devices Regulation’s (MDR) and the In-vitro diagnostic Medical Devices Regulation’s (IVDR) effective dates of 2021 and 2022, respectively have already closed. In the absence of a new MRA, Switzerland currently has “third country” status with the EU; as a result, goods such as medical devices and IVDs can no longer be freely shipped between Switzerland and the EU.
In order to manage their device registrations in Switzerland, manufacturers must now comply with the requirements of the Medical Devices Ordinance (MedDO) and the Ordinance on In-vitro Diagnostic Medical Devices (IvDO), register with Swissmedic, and designate Swiss Authorized Representatives (CH-REP).
However, it is anticipated that devices approved by the US Food and Drug Administration (FDA) would be recognized under future Swiss legislation. Swiss regulations do closely accord with standards of the EU MDR and IVDR, on the other hand CE certifications are still recognized in the nation.
Deadlines for CH-REP Compliance Have Passed
Manufacturers of Medical Devices and IVDs should be aware that all deadlines for designating the CH-REP have passed and are still in effect up until the creation of a new MRA between the Swiss and EU governments.
| December 31, 2021 | Risk Class |
|---|---|
| For Medical Device Manufacturers | |
| December 31, 2022 | Class III, Class IIb implantable and active implantable devices |
| March 31, 2022 | Class IIb non-implantable and Class IIa devices |
| July 31, 2022 | Class I devices |
| For IVD Manufacturers | |
| December 31, 2022 | Class D devices |
| March 31, 2022 | Class B and C devices |
| July 31, 2023 | Class A devices |
Additionally, Manufacturers must ensure that their labels contain details identifying their CH-REPs.
