Swiss Federal Council Announces Measures on IVD Supply and Medical Device Transparency
The Swiss Federal Council has announced measures intended to support the supply of in vitro diagnostics, IVDs, and increase transparency in medical devices.
At its meeting on 14 August 2024, the Federal Department of Home Affairs, FDHA, informed the Federal Council that transition periods for new IVD requirements in Swiss law should be adjusted and extended in line with EU regulation. The communication also states that simplified labelling requirements for certain IVDs should continue indefinitely, and that the obligation to register medical devices and IVDs in a central database should enter into force in 2026.
Background
The communication explains that IVDs are used to examine body fluids, body secretions and tissue outside the body.
Examples include COVID-19 rapid tests and blood tests for early cancer detection, which are used daily in hospitals, laboratories and medical practices.
The European Union tightened regulation for IVDs and medical devices in 2017 to improve quality and safety. Switzerland introduced equivalent legislation to maintain the same level of patient safety.
Extension of IVD Transition Periods
The communication notes that deadlines were set for the transition to new legal requirements for IVDs.
After the transition periods expire, IVDs must comply with the new requirements, otherwise they may no longer be sold in Switzerland and the EU. However, the communication states that existing deadlines are not sufficient for all products to meet the new requirements.
To reduce the risk of supply bottlenecks, the EU decided to extend transition periods under certain conditions. Switzerland intends to reduce this risk as well and maintain equivalent legislation with the EU by incorporating the new EU transition periods into the Ordinance on In Vitro Diagnostics, IvDV.
Simplified Labelling Requirements
Since May 2022, Switzerland has been considered a third country by the EU in the area of IVDs.
As a result, important simplifications for trade in these products between Switzerland and the EU no longer apply. To reduce additional effort and costs for companies, the Federal Council introduced several measures, including temporary relaxation of labelling requirements for IVDs not intended for self-use.
The communication states that this measure has proven successful and should be retained indefinitely. It facilitates distribution of certain IVDs on the Swiss market and contributes to security of supply.
Product Registration in swissdamed From 2026
The current provisions of the Medical Devices Ordinance, MepV, and the IvDV already stipulate that products must be registered in a central database.
The purpose is to increase transparency, provide information on products available on the Swiss market and ensure an overview of the available product range.
For this registration, Swissmedic is developing the Swiss Database on Medical Devices, swissdamed. The communication states that certain parts of swissdamed are planned to be available on a voluntary basis in 2025 for registration of certain products, while the product registration obligation is expected to enter into force in 2026.
Impact on IVD and Medical Device Manufacturers
For IVD manufacturers, medical device manufacturers, Swiss authorised representatives, importers and distributors, the communication is relevant because it points to continued alignment with the EU framework and confirms the upcoming role of swissdamed in product transparency.
Stakeholders should pay particular attention to:
extended IVD transition periods;
alignment between Swiss law and EU IVD requirements;
supply continuity and risk of IVD shortages;
indefinite continuation of simplified labelling for certain non-self-use IVDs;
registration obligations under MepV and IvDV;
voluntary swissdamed availability expected in 2025;
mandatory product registration expected from 2026;
product data readiness and internal registration processes;
market surveillance and transparency expectations in Switzerland.
For companies placing IVDs and medical devices on the Swiss market, the key message is that Switzerland is maintaining a supply-focused and transparency-focused approach while preparing for central product registration through swissdamed.
