Ensure Your Device’s Entry into the Swiss Market with Confidence
Optimize your operation with MedEnvoy as your single designated Swiss regulatory importer for medical device and In Vitro Diagnostics (IVDs) manufacturers.
Swiss Regulatory Importer to Meet Swissmedic Requirements
Why do you need a Swiss regulatory 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).
Trusted Swiss Regulatory Importer for Compliance
By working with MedEnvoy as your Swiss Regulatory Importer, 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 regulatory importer and UK regulatory importer for 500+ medical device companies, so we have processes established to verify your compliance quickly and seamlessly with swissmedic requirements.
As your Swiss Regulatory 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.
FAQs
How are medical devices regulated in Switzerland?
After the Medical Device Regulation (MDR) went into effect on May 26, 2021, Switzerland became what is considered a “third country” with regards to the free movement of medical devices. After that time, medical devices were regulated in Switzerland by the Medical Device Ordinance (MedDO), which is close to being a verbatim transposition of the MDR and where the importer and Switzerland Authorized Representative (CH-REP) have identical responsibilities and non-Swiss-based manufacturers require an importer and CH-REP. Medical devices on the Swiss market will still require the Conformitè Europëenne (CE) marking.
What is swissmedic?
The Swiss Agency for Therapeutic Products is the Swiss surveillance authority for medicines and medical devices.
How are IVDs regulated in Switzerland?
After the In Vitro Diagnostic Regulation IVDR went into effect on May 26, 2022, Switzerland became what is considered a “third country” with regards to the free movement of in vitro diagnostic medical devices (IVDs). After that time, IVDs are regulated in Switzerland by the Swiss Ordinance on In Vitro Diagnostic Medical Devices (IvDO), which is close to being a verbatim transposition of the IVDR and where the importer and Swiss Authorized Representative (CH-REP) have identical responsibilities. While this is separate from the rules of the IVDR, IVDs will still require an importer and a CH-REP for manufacturers outside of Switzerland. IVDs on the Swiss market
will still require the Conformitè Europëenne (CE) marking.
Is swissmedic accepting electronic IFUs?
For Switzerland the respective law closely copies the MDR.
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.
Where do we need to identify the Swiss Regulatory Importer?
The Swiss Importer must be identifiable on the product, the product packaging or a document enclosed with the product. The Swiss authorities provided recently some additional guidance, that the importer mentioning should reach the end user.
Therefore, our understanding is that the importer should be identifiable on the label, the IFU, or any other document that reaches the end user.
Are there any specific requirements for the Swiss Declaration of Conformity (DoC)?
The MepV indicates in Article 29 that the DoC must be prepared in accordance with Annex IV of the MDR.
This means that the manufacturer must be mentioned and the CH AR, if applicable. The importer does not have to be mentioned.
EU Regulatory Importer
UK Regulatory Importer
India Authorized Importer
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