gtag('config', 'AW-438500021');
 
about-us.jpg

Common Questions
About Swiss Importer & CH-REP Services

These are the most common questions asked by our medical device and IVD clients exporting to Switzerland. If you do not find the answer you are looking for, please feel free to contact us.

Audits


Representation

Does the Swiss Authorized Representative (CH-REP) need to have their own Person Responsible for Regulatory Compliance (PRRC)?


Yes, the Swiss CH-REP needs to have an own PRRC, indepedent from the manufacturer




Do Switzerland have an equivalent of the Person Responsible for Regulatory Compliance (PRRC) as exists in the EU?


Yes, it does. Art. 49 par. 2 of the MedDo specifically refers to Art. 15 MDR, including the qualifications mentioned there. However, in an unexpected gesture to the EU, the PRRC of the CH REP may be based in EU, should the CH REP so decide.




Are there special qualification(industry experience or education) requirements for the Swiss Authorized Representative?


No. Art.51 Par.1 of the MedDo as amended simply refers ot Art. 11 of the MDR. However, to be able to perform the tasks elaborated in that article, it is obvious that the AR has to have in-house adequate experience and skills to perform the tasks. Were that not the case, the liability referred to in par. 5 of the MDR would be unsupportable.





Shipping/Customs

Can we mention MedEnvoy as importer on our shipping documents?


Yes, but noting MedEnvoy only on the shipping documents does not suffice as these do not reach the end user.





EUDAMED


General


Labeling/IFU/DoC

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. This means that the manufacturer must be mentioned and the CH AR, if applicable. The importer does not have to be mentioned.




Where do we need to identify the Swiss 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.




Where should we indicate our Swiss Authorized Representative (CH-REP) on our devices?


The CH-REP has to be on a labeling component that will be available to the end-user at the point of use, e.g. shelf box or sterile packaging, preferentially but not mandatorily on the device label. The CH REP may be on the IFU, if the IFU accompanies the product to the point-of-use, similar to the European Authorized Representative.




Is it possible to place both the CH-REP and the importer symbol next to MedEnvoy Switzerland name and address on the label?


Yes, this is possible. Please note that the importer symbol needs to be explained, e.g. in the IFU, since this are not harmonized. The CH-REP symbol can be used without an explanation.




Should the MedEnvoy name/address be translated differently depending on the language of the IFU?


Both the name and address of MedEnvoy can stay the same on all versions of the IFU and do not have no be translated.




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





Legacy Devices


Legal & Liability


Registration

Do we need a Swiss Registration number?


To mitigate the consequences of loss of information and to continue to ensure market surveillance in Switzerland, it is necessary for manufacturers, authorised representatives and importers domiciled in Switzerland to register once with Swissmedic. After the successful review of the information, Swissmedic will assign a Swiss Single Registration Number (CHRN) to the applicant.




What are the timelines for registration in Switzerland?


The amendment to the Swiss Medizinprodukteverordnung (MedDO) states that Swiss Authorized Representatives (CH-REPs) must register themselves at Swissmedic within three months after first placing devices on the market (Article 55). Article 104a of the amendment however provides for extra time for mandating the CH-REP for EU or EEA based manufacturers, or for manufacturers that have an Auhtorized Representative based in the EU or EEA:


1. For Class III devices, Class llb implantable devices and active implantable devices the CH-REP must be mandated by December 31, 2021;
2. For Class llb non-implantable devices and Class lla devices the CH-REP must be mandated by March 31, 2022;
3. For Class I devices the CH-REP must be mandated by July 31, 2022.

Currently non-Swiss manufacturers and devices cannot be registered with Swissmedic. Guidance from Swissmedic concerning the registrations is expected soon and should include more details on the registration requirements.





Need more details? Contact us

Contact us for a free, no obligation proposal