Optimize your operation with MedEnvoy as your single designated Swiss regulatory importer for medical device and In Vitro Diagnostics (IVDs) manufacturers.
Independent Representation for Meeting Swissmedic Requirements from the #1 Regulatory Importer
Wondering why you need a Swiss importer? Switzerland is not an EU member but has traditionally traded with its neighbors in Europe under a Mutual Recognition Agreement (MRA). The MRA has not been renewed since the adoption of the EU Medical Device Regulation (2017/745), so now Switzerland is a “third country” much like the UK. As such, manufacturers located outside of Switzerland must appoint a Swiss Regulatory Importer and Swiss Authorized Representative (CH-REP).
Ensure Compliance with Swissmedic Requirements
By working with MedEnvoy as your Regulatory Importer in Switzerland, you avoid asking your distributor to take on this responsibility and therefore maintain more independence at a minimal cost while also alleviating a burden for your distributor.
MedEnvoy also fulfills the role of EU importer and UK importer for 500+ medical device companies, so we have processes established to verify your compliance quickly and seamlessly with Swissmedic requirements.
As Your Swissmedic Compliance Importer, We Will:
- Verify Swiss declaration of conformity and technical documentation
- Verify labeling, IFU, and that UDI has been assigned
- Verify that manufacturer and importer are identified
- Verify that Swiss storage and transportation requirements are fulfilled
- Maintain a register of complaints as required by Swiss law
- Inform manufacturer if device provides serious risk or is not in conformity
- Check to ensure that devices have been registered with Swissmedic
- Report serious incidents or risks to Swissmedic
- Cooperate with Swissmedic regarding preventive/corrective action
Let’s talk. Request your free proposal and we’ll get right back to you!
Münsterbrücke, Zürich
150+ Medical Device & IVD Manufacturers Trust MedEnvoy as Their Swiss Importer
Frequently Asked Questions About Requiring a Swiss Regulatory Importer:
will still require the Conformitè Europëenne (CE) marking.
Annex I CH. III of the MDR (p.103-107) deal with “Requirements regarding the Information supplied with the Device”. Section 23.1 (a) and (C0 allow for “human-readable format”, which can be “..supplemented by machine-readable information”.
Art. 16 of the Swiss MedDo (MepV) “Product Information” , Par. 1 states” The product Information consists of the labeling and the Instruction for Use in accordance with Annex I Chapter II of the MDR.
Therefore the MedEnvoy position is, that the Swiss regulations will allow e-IFUs under the same conditions as the MDR, with one important caveat: unless the exemptions listed in Art. 16. Par.3.
In addition the translations must be provided in all three required languages: German, French and Italian.
Therefore, our understanding is, that the importer should be identifiable on the label, the IFU, or any other document that reaches the end user.
This means that the manufacturer must be mentioned and the CH AR, if applicable. The importer does not have to be mentioned. This means that the manufacturer must be mentioned and the CH AR, if applicable. The importer does not have to be mentioned.