Questions & Answers
Here you will find the most common types of help available from Swiss AR Services
General questions
Due to the failed negotiations on a new framework agreement between the EU and Switzerland, conformity assessment of medical devices will no longer be mutually recognised since the MDR comes into force (26.05.2021).
In order to continue to market medical devices in Switzerland, all MDD/MDR devices, as well as Class I, II & III treatment units, must be registered by 31 July 2022.
For the mandating of a Swiss representative, the following data apply for in-vitro diagnostic products.
- Until 31 Dec 2022 (IVDD/IVDR) - IvD Class D
- Until 31 Mar 2023 (IVDD/IVDR) - IvD classes C and B
- Until 31 Jul 2023 (IVDD/IVDR) - IvD Class A
No
It is not mandatory to mention Swiss AR Services by name in your own policy. Including Swiss AR Services in your own insurance policy may reduce the amount insured by Swiss AR Services.
No.
We only check that the EU declaration of conformity and the technical documentation have been drawn up and that the manufacturer has carried out an appropriate conformity procedure, if applicable.
Yes, every article in a system or procedure pack must have a CH-REP.
No.
Only significant changes to the product, as well as changes to the labeling, must be communicated to Swiss AR Services.
Approval by Swiss AR Services is not required.
On September 2, 2021, Swissmedic communicated that the process would take around 1-2 weeks. However, Swissmedic has already announced that it will probably take significantly longer due to the large rush shortly before the end of the transition periods.
The registration of the mandate must take place no later than 3 months after the first placing of a product on the market.
We will be happy to recommend an appropriate contact for this purpose. Please contact us for this purpose using the contact form.
Every healthcare facility that handles medical devices is subject to the duty of care and in doing so must take all measures that are necessary according to the state of science and technology to ensure that health is not endangered.
Swissmedic recommends that healthcare facilities include a check of conformity with the applicable regulatory requirements in the procurement process for medical devices and that they check and retain the evidence of product conformity (declaration of conformity and EC certificates).
Information and assistance on medical device procurement in healthcare facilities:
LINK
Yes. We also offer the service as CH-REP for IVD products.
No.
Only one CH-Rep can act per product.
Theoretically, however, it is possible for a manufacturer to designate different CH-Rep for its product groups.
Labelling
The product labeling is in accordance with Annex l Chapter lll EU MDR. In addition, the label must show the name & address of the CH-Rep as required by Swissmedic. (Swissmedic)
It is not sufficient if, for example, only the shipping unit is labelled. The CH-Rep must be visible on all sales packaging. It does not matter whether you adapt the design, affix the sales packaging yourself or have your distributor do it.
The product information includes labeling and the instructions for use. It must be written in the 3 official languages (German, Italian, French).
The product information may also be limited to fewer than 3 official languages or to English, provided that the defined exceptions to MepV Art. 16 are complied with.
Costs
Onboarding costs are divided into 2 categories.
Onboarding of the manufacturer:
These costs cover the eye iron of the business relationship between the manufacturer and Swiss AR Services and are charged once.
Onboarding of products
These costs cover the review of technical documentation and are charged once on a time and material basis.
No.
Depending on the effort, we will charge the additional costs for checking the change of files from MDD to MDR on a time and material basis.
As we are jointly liable for your products, we must take out appropriate insurance. The insurance depends on the turnover and the MD class. We want to be very transparent with you here and do not charge flat rates.
Privacy
Swiss AR Services is operated on a modern cloud infrastructure in Switzerland.
On the one hand, the servers of Swiss AR Services are located at a Swiss-based IT service provider and the cloud data is in a multi-certified and secured data center in Switzerland.
The connection to our servers is made using SSL encryption. We regularly perform backups of customer data. In order to prevent data loss even in extreme cases (e.g. destruction of data center by an earthquake), we reserve the right to store encrypted backups in several data centers in Switzerland and abroad. Our security measures are continuously adapted and improved according to technological developments.
You can find our partner/provider here:
- IT service provider
SOWARIS GmbH - Cloud solution
Microsoft Office 365 - Digital signature
Skribble AG - Business Software
BEXIO AG - Quality Management
Q|Sistant GmbH
(The partners also publish information about their certifications on their respective websites).
We can delete the data, but we must retain some data to document the business relationship (e.g. invoices, ...). This is to fulfill the legal retention period.
We offer functions in our systems to download the data in common formats. We do not offer a copy of the database "DB dump" for security reasons.
The order processing agreement (ABV) is part of our manufacturer contract and is therefore concluded when the contract is signed. A separate signature is therefore not necessary.
In order to completely dispense with physical receipts, documents must be archived in accordance with the Business Records Ordinance, such as the GeBüV of Switzerland. In addition, the retention obligations according to Art. 958f OR must be observed. Our document storage is not GeBüV certified/ attested. It is the responsibility of the user to clarify whether their document storage system complies with GeBüV. Certification is not required by law.
We process the collected data to;
- to be able to constantly improve the services you request,
- to manage your usage and desired access to our applications, products and information,
- to maintain our business relationship with you,
- to monitor and improve the performance of our offering,
- to detect, prevent or resolve illegal activities
- and to send you offers, information or marketing materials about products or services that we think may be of interest to you based on the data.
The data may also be passed on to partner companies and service providers, selected third-party companies, institutes and/or legally authorized government authorities, both in Germany and abroad, for processing, storage and use within the scope of the above-mentioned purposes. We have individual of the aforementioned processes and services carried out by service providers commissioned in accordance with data protection law who are based within the EU or Switzerland. These are companies in the categories of IT services, payment transactions, printing service providers, billing, collection and consulting as well as sales and marketing and service providers that we use in the context of order processing relationships.
If you are unsure, you are also welcome to ask new questions or respond further to existing questions. Our competent team will take care of your request as quickly as possible and constantly update our Q&A database.
Should you still not find an answer here or prefer direct customer contact, please do not hesitate to contact our team using our contact form.