You are unsure what you have to consider as a Swiss importer? We have summarized the most important points for you.
You are unsure what you have to consider as a Swiss importer? We have summarized the most important points for you.
The responsibilities of a Swiss importer under the MepV/IvDV are similar to those of an importer under Article 13 of the EU MDR/IVDR. According to Article 53 of the MepV and Article 46 of the IvDV, the Swiss importer’s obligations can be divided into the following areas:
1. compliance verification:
Before a product is “placed on the market” in Switzerland in accordance with Article 53(1) of the MepV and Article 46(1) of the IvDV, it is the responsibility of the Swiss importer to ensure that the product complies with the requirements. This includes:
- Verification that the product bears the CE marking,
- Verification that a declaration of conformity is available,
- The confirmation that the manufacturer has appointed a Swiss authorized representative,
- Verification that the product is labeled in accordance with the requirements of the MepV/IvDV, and
- Determining whether a UDI (Unique Device Identification) has been assigned by the manufacturer, if applicable.
The Swiss importer must keep declarations of conformity and, where applicable, certificates in accordance with Article 13(9) of the EU MDR/IVDR for a period of 10 years (15 years in the case of implantable devices) from the last placing on the market.
Furthermore, according to Article 21(2) of the MepV and Article 17(2) of the IvDV, the Swiss importer is obliged to prove that the conformity assessment has been carried out and that the product complies with the regulations. If a product does not comply with the requirements of the MepV/IvDV, it must not be placed on the market before conformity has been established, in accordance with Article 53(3) of the MepV and Article 46(3) of the IvDV.
In addition, the importer must have a process for notifying the manufacturer and its Swiss authorized representative when nonconformities occur.
Among the responsibilities of a Swiss importer is the verification of various conformities-.
2. appropriate storage and transportation conditions:
While the product is the responsibility of the Swiss importer, the storage and transport conditions in accordance with Article 13(5) of the EU MDR/IVDR must not jeopardize the conformity of the product with the general safety and performance requirements of the EU MDR/IVDR. The importer must also comply with the storage and transport conditions specified by the manufacturer, if any.
3. traceability of the products:
According to Article 64 of the MepV and Article 57 of the IvDV, the Swiss importer must cooperate with the manufacturer or his Swiss authorized representative to ensure the traceability of the products. This includes notification of the identity of the economic operators from whom the importer has acquired a medical device and of the economic operators or customers to whom the importer has supplied a medical device. According to Article 47c of the Swiss Therapeutic Products Act (TPA), the importer is obliged to provide this information to Swissmedic. The notification requirement applies for a period of at least 10 years (15 years for implantable devices) from the date of acquisition or delivery.
4. register for complaints, non-conforming products, recalls and withdrawals:
Analogous to Article 13(6) of the EU MDR/IVDR, the Swiss importer must maintain a register for complaints, non-compliant products, and recalls and withdrawals. He is obliged to provide the manufacturer, his Swiss authorized representative and the distributors with all requested information to enable a proper investigation of the complaints.
5. communication:
The importer shall immediately forward all complaints and incidents to the manufacturer and its Swiss authorized representative. If a non-compliant product poses a serious risk, the importer informs Swissmedic immediately. This shall indicate the non-compliance and the corrective action taken in accordance with Article 13(7) of the EU MDR/IVDR.
6. collaboration:
The Swiss importer shall cooperate with Swissmedic, the Notified Body (if any), the manufacturer and its Swiss authorized representative in taking corrective action to bring a device into compliance (including recalls and withdrawals) in accordance with Article 13(10) of the EU MDR/IVDR.
7. registration with Swissmedic (CHRN):
“In accordance with Article 55(1) of the MepV and Article 48(1) of the IvDV, the Swiss importer must register as an economic operator with Swissmedic and obtain a Unique Swiss Registration Number (CHRN).”
Registration takes place at different times:
- When the importer first places either a non-IVD product on the Swiss market after May 26, 2021, or an IVD product on the Swiss market after May 26, 2022, registration must occur within three months.
- If the importer has already placed EU MDR-compliant products on the Swiss market before May 26, 2021, the registration had to be done before November 26, 2021.
- If the importer has already placed IVDR-compliant IVDs on the Swiss market for the first time before May 26, 2022, he must register before November 26, 2022, in accordance with Article 88 of the IvDV.
- For importers who have already placed “legacy” non-IVDs on the Swiss market before May 26, 2021, or “legacy” IVDs on the Swiss market before May 26, 2022, there will be no registration
8. data specification
According to Article 53(2) of the MepV and Article 46(2) of the IvDV, the contact details of the Swiss importer must be indicated on the product, the packaging or an accompanying document such as an invoice, a delivery bill or a guarantee. For more information, please refer to the fact sheet on the obligations of economic operators published by Swissmedic.
However, should you have any unanswered questions, we will be happy to assist you at any time with regulatory and quality assurance matters in the area of direct and parallel imports with a focus on the Swiss market. We support you in complying with the applicable regulations efficiently and reliably.
