What is IVDO?

The SWISSMEDIC, Switzerland’s Agency for Therapeutic Products, announced the establishment of a new ordinance on “In Vitro Diagnostic Medical Devices” (IVDO; SR. 812.219), which came into effect on May 26, 2022. The ordinance is applicable for the ‘In Vitro Diagnostic’ (IVD) devices that will be placed in the Swiss market. The ordinance was drafted in line with the ‘European Union In Vitro Diagnostic Medical Devices Regulation’ (EU IVDR) 2017/746.

What are the Other IVD Regulations Currently Applicable in Switzerland?

The other regulations for IVD under the Swiss law are –

• Therapeutic Products Act
• Product Liability Act
• Ordinance on Electromagnetic Compatibility
• Machine Ordinance
• Federal Act on Technical Trade Barriers
• Federal Law on Data Protection
• Federal law on product safety
• Chemicals Act
• Measurement Law
• Radiation Protection Act
• Medical Device Ordinance

What are the IVDO Requirements to Place the Product on the SWISS Market?

The IVDO provides detailed requirements for the IVDs to be placed on the market. The document is currently available in three (03) languages. The requirements include:

• Conformity Marking
• Registration of Economic Operator
• UDI Registration
• Device Notification
• Reporting of any Product-related Incident

Who Should be Registered as per the IVDO?

All the Economic Operators (EOs), including manufacturers, importers, and authorized representatives, must register with the Swissmedic. The EOs must register within three (03) months of launching the devices for the first time in the market. The EOs, who have launched the products before May 26, 2022, under the EU IVDR 2017/746, are required to register according to the new regulations before November 26, 2022.

In case of any changes concerning the information of economic operators, the Swissmedic is required to be reported within a week.

What is the CHRN Number?

Upon EOs registration with the Swissmedic, the Agency examines the information and assigns them a unique SWISS registration number called CHRN. The number is used explicitly to identify the manufacturers, importers, and authorized representatives. 

The Economic Operators are required to apply online through an electronic application form - “Application CHRN” along with other information and documents required. Later, the application should be submitted by email to srn@swissmedic.ch. The fee involved in issuing CHRN and validating documents is usually CHF 200 per hour but is dependent on the work involved.

What is the role of a CH-Rep under IVDO?

Under IVDO, it is mandatory for foreign manufacturers based outside Switzerland to appoint a CH-rep to place their devices in the Swiss market. CH-Rep acts on behalf of these manufacturers, ensure conformity with the device, liaises with the competent authorities, and carries out Post-Market Surveillance (PMS) activity. The transition timelines for appointing CH-rep under IVDO compliance are as follows:

How Can an IVD be Registered with the Swissmedic?

Manufacturers are required to notify Swissmedic while placing the IVDs in the market for the first time. Original copies of the standardized notification forms should be sent to the Swissmedic, along with other required documents for registration.

IVDs that are repacked, relabelled, and manufactured and which are used in healthcare institutions must also be notified to the Swissmedic. Class A (Sterile), Class B, Class C, and Class D must be notified individually. At the same time, Class A (non-sterile) can be notified individually or as device groups.

What are the Requirements for UDI Registration?

The manufacturers must follow the guidance document published by the European Commission for the UDI system, along with registration with the EUDAMED and affixing the UDI carrier on the labeling of the device.

The list of issuing bodies charged with implementing an UDI system in accordance with the EU IVDR 2017/746 is as follows:

• GS1 AISBL
• Health Industry Business Communications Council (HIBCC)
• ICCBBA
• Informationsstelle für Arzneispezialitäten – IFA GmbH

What are the Requirements for Reporting an Incident of IVDO?

During the post-market surveillance, if the need for Corrective and Preventive Action (CAPA) emerges for any IVD, the manufacturers shall take the mandatory steps to mitigate the risk and must inform the competent authorities and notified bodies (wherever applicable).

In case of any serious incident, the manufacturer must immediately report it to the Swissmedic as per Article 59 of IVDO. 

What about the Products in Compliance with the Old Law?

The products complying with the old law (CE-marking) can be continued to be placed in the market unless there is a change in the design and function of the product in issue has not changed significantly. They can be placed on the market or put into operation by the following dates:

Are you looking for more details on the IVD ordinance and its role in placing IVD devices in the Swiss market? You can reach out to us at sales@freyrsolutions.com.