Source: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/haeufige_fragen-faq.html
Timestamp: 2020-08-04 04:58:27
Document Index: 119878804

Matched Legal Cases: ['Art. 6', 'Art. 6', 'Art. 6', 'Art. 6', 'Art. 6', 'Art. 6', 'Art. 6', 'Art. 6', 'Art. 6', 'Art. 6', 'Art. 6', 'Art. 6', 'Art. 1', 'Art. 1', 'Art. 2', 'Art. 6', 'Art. 6']

Single Registration Number (SRN)
FAQs: Notification for the placing on the market of a medical device according to Art. 6 of the Medical Devices Ordinance (MedDO, SR 812.213)
1. Do all devices that are to be marketed in Switzerland have to be notified to Swissmedic according to Art. 6 of the Medical Devices Ordinance (MedDO, SR 812.213)?
a. Class I, Custom-made devices, systems and procedure packs: These devices must be notified to Swissmedic by the entity first placing them on the market whose place of business is in Switzerland (manufacturer or authorised representative) when they are first placed on the market in Switzerland or in a treaty country (i.e. EU Member States, EFTA States and Turkey).
b. Classes IIa, IIb, III and active implantable medical devices (AIMD): No, Swissmedic does not need to be notified.
c. In-vitro diagnostics (IVD): See Information Sheet, Section 2.
d. Devitalised human tissue: Yes, Swissmedic must be notified in every case by the entity placing the device on the market.
2. Do Swiss manufacturers/authorised representatives have to provide notification of a device even if it is not to be marketed in Switzerland?
a. Class I, Custom-made devices, systems and procedure packs, in-vitro diagnostic medical devices (IVD):
i. Yes, if they place it on the market in an EU Member State, EFTA State or Turkey (see also answer to question 1 a).
ii. No, if it is not marketed in an EU Member State, EFTA State or Turkey.
b. Devitalised human tissue: No. Please note that the conformity assessment requirements pertaining to these devices are not currently harmonised in Europe. While regulation in Switzerland is based on medical devices legislation, differing procedures are defined in other countries. For medical devices containing devitalised tissue, it is thus not possible either to obtain CE marking of these devices based on European medical devices legislation or to trade them freely between Switzerland and the EU, EFTA or Turkey. Thus the national laws are decisive for any such devices that are to be marketed in other countries.
3. Why does Swissmedic not indicate individual product names on the acknowledgement of receipt for „IVD other“?
For IVD devices of the class „IVD other“, the regulation (IVD Directive 98/79/EC, Medical Devices Ordinance SR 812.213) does not require registration at the level of individual product names. Therefore, Swissmedic will not register these IVDs individually by product name. The corresponding acknowledgment of receipt will not contain a product name.
For IVD devices of the class “List A”, “List B” and “self-testing”, however, the regulation (IVD Directive 98/79/EC, Medical Devices Ordinance SR 812.213) requires registration at the level of individual product names. Swissmedic will register such devices with individual product names. The corresponding acknowledgment of receipt will contain the product name.
For IVD devices of the class „IVD other“, the following points are to be taken into account:
a. „IVD other“ can be notified as groups. This means that one single GMDN code (or EDMS code) notified may cover several „IVD other“ devices. The regulation (IVD Directive 98/79/EC, Medical Devices Ordinance SR 812.213) does not envisage individual product names of such „IVD other“ devices being specifically registered.
b. Once a manufacturer has notified such an „IVD other“ device with a GMDN (EDMS) code, this manufacturer is free to market further “IVD others” falling under the same GMDN (EDMS) code. The first notification will cover all future “IVD others” devices of the same GMDN (EDMS) code. Indicating a product name on the notification form of “IVD other“ devices is counterproductive because this may impede further “IVD others” of the same GMDN (EDMS) code being covered by the first notification.
c. The same applies to cancellations (“discontinuation of placing on the market by the manufacturer”): if a manufacturer is no longer placing one of several products of a notified group on the market, no report need be sent. The report to the effect that the manufacturer is no longer placing the product on the market must only be sent when the entire group is discontinued, i.e. when no products in the group are being placed on the market any more.
4. As of when will a fee be payable for notifying the placing on the market of medical devices according to Art. 6 MedDO?
As of 1 January 2019, a fee (CHF 300 per notification) will be charged for all notifications according to Art. 6 MedDO. The decisive factor in charging this fee will be the date of receipt of the complete notification via the relevant form.
5. Why are notifications for the placing on the market of medical devices according to Art. 6 MedDO subject to a fee of CHF 300 for each notification as of 1 January 2019?
According to the Ordinance on Fees Levied by the Swiss Agency for Therapeutic Products (FeeO-Swissmedic, SR 812.214.5), notifications for the placing on the market of medical devices according to Art. 6 MedDO will be subject to a free from 1 January 2019. The amount of the fee is specified in Annex 2 section 1.1 of the FeeO-Swissmedic.
6. For what notifications is a fee charged?
For all notifications according to Art. 6 MedDO. A fee is not charged for amendments to a notification.
7. Do I have to pay CHF 300 for each individual device notified, or is it possible to notify several devices on one form?
a. Class I, custom-made devices, systems and procedure packs (Art. 6 para. 1 MedDO): Complete a notification form for each device group or each device (one GMDN/UMDNS code per notification). Note regarding the notification of more than one product: Please note that, for reasons of simplicity, multiple devices sharing the same GMDN/UMDNS code should, if possible, be grouped together on the same notification form, and the different devices listed in an attached list.
b. In-vitro diagnostics (IVD) (Art. 6 para. 2 MedDO): See Information Sheet, Section 3.
c. Devitalised human tissue (Art. 6 para. 3 MedDO): One notification should be submitted for each tissue type and devitalisation process.
8. Is there any change to the submission practice due to the introduction of fees?
No, the submission process through to completion and receipt of the confirmation of receipt remains the same for you. The invoice will automatically be posted to you under separate cover.
9. Who is the invoice recipient?
If several stakeholders are listed in the notification (e.g. manufacturer and its authorised representative), the invoice is always sent to the address in Switzerland.
Note for notifications according to Art. 6 para 3 MedDO (devitalised human tissue): If several entities in Switzerland are placing the device on the market, each one receives an invoice separately.
10. How can I assign an invoice to a notification?
The notification forms now include a field for the company's purchase order number (PO). This purchase order number is printed on the invoice and allows you to assign the invoice to your notification. In addition, the name of the notifying person (according to the form) is printed on the invoice.
11. What is changing as a result of the revised European Regulations?
See the Swissmedic website:
12. Do class I medical devices that are currently notified to Swissmedic according to Art. 6 MedDO need to be renotified on the basis of the MDR if a) the devices are still class I devices under MDR or b) the devices have a higher classification under MDR?
a. A notification must be submitted to Swissmedic while EUDAMED is still not operational (see also the Swissmedic website:
b. No, a notification does not need to be submitted to Swissmedic (see also answer to question 1 b).
13. How will classical and active implantable medical devices that were derived from, or that incorporate, devitalised human tissue be treated in Switzerland in future under the revised European Regulations?
Art. 1 para. 6 g MDR states that the Regulation applies to products manufactured utilising derivatives of tissues or cells of human origin which are non-viable or are rendered non-viable and then, in Art. 1 para. 10 MDR, that those devices with an ancillary function are also regulated by the MDR. However, if the action of those tissues or cells or their derivatives is a principal action and not ancillary to that of the device, the product shall be governed by Directive 2004/23/EC. As a result, those devices that are covered by Directive 2004/23/EC but not by the MDR can also no longer be considered as medical devices in Switzerland, and consequently the current Swiss provisions as per Art. 2 para. 1 MedDO can no longer be applied to this type of device. According to our latest information, regulation comparable with that for transplant products, with certain transitional arrangements, is envisaged for devices that are currently notified to Swissmedic according to Art. 6 para. 3 MedDO. For further details concerning the future Swiss legislation in this context please contact the responsible body, the Federal Office of Public Health: https://www.bag.admin.ch/bag/en/home/medizin-und-forschung/heilmittel/aktuelle-rechtsetzungsprojekte/revision-med-prod-verord-mepv.html). You can find further details and the latest news about the current regulation of transplant products at: https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/besondere-arzneimittelgruppen--ham-/transplant-products/regelung-von-transplantaten--organen--gewebe-und-zellen-.html
14. What happens after the switch to the European database for medical devices (EUDAMED)?
Notifications relating to MDR/IVDR medical devices cannot currently be uploaded to the current EUDAMED database because the existing EUDAMED database is not set up for devices covered by the MDR/IVDR, and the new EUDAMED is not yet operational. The requirements pertaining to EUDAMED stated in the new Regulation must be fulfilled by the manufacturer at a later date for the devices concerned.
BW530_00_004e_MB FAQs: Notification for the placing on the market of a medical device according to Art. 6 of the Medical Devices Ordinance (MedDO, SR 812.213) (PDF, 245 kB, 02.12.2019)
https://www.swissmedic.ch/content/swissmedic/en/home/medical-devices/market-access/haeufige_fragen-faq.html