Medical Devices Ordinance
The Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219) set out requirements and responsibilities for operators in the medical devices supply chain. Swiss Authorised Representative, the importer and the distributor has different roles and obligations.
Swiss Authorised Representative (CH-REP)
Manufacturers who are not based in Switzerland, will need to appoint a Swiss Authorised Representative.
With our Swiss Authorised Representative service we will
• Verifying the documentation and the Technical File
• Register devices with Swissmedic
• Represent the manufacturer in Switzerland
• Keep a copy of the Technical File for inspection by Swissmedic
• Work with Swissmedic for information upon request
• Inform the manufacturer of complaints and incidents
• Provide assistance for registration on Swissmedic
Medical Device Marking
The Medical Devices must mark with the CH Authorised Representative symbol.
The name and address of the Authorised Representative must appear adjacent to the symbol. The address must enable contact to be established with the Swiss Authorised Representative.
The relative size of the symbol and the size of the name are not defined, but they must be clearly legible to the naked eye.
When symbols are used, they must as a rule conform to the harmonised standards. If no such standards exist for the area concerned, the symbols must be explained in the product documentation enclosed. In this case Swissmedic accepts the sole use of the symbol without any description of the symbol in the product documentation enclosed.
Swiss Single Registration Number (CHRN)
Based on the Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR. 812.219) Swissmedic, the Swiss Agency for Therapeutic Products, assigns the Swiss Single Registration Number (CHRN). The Swiss Single Registration Number (CHRN) is a Swiss unique registration number that Swissmedic assigns to Swiss manufacturers, Authorised Representative and importers upon request. The CHRN is used to unambiguously identify a manufacturer, Authorised Representative or importer.
Until the MRA (Mutual Recognition Agreement) is updated, Swissmedic is unable to assign a European Single Registration Number (SRN) via EUDAMED for economic operators who are domiciled in Switzerland. To mitigate the consequences of this 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.
Economic operators must register within three months of placing their first product on the Swiss market. This timeframe is intended to avoid delays in bringing compliant products onto the market and to prevent supply bottlenecks in Switzerland.
Once an economic operator has registered, it does not have to do so again when placing further products on the market.
Notification of Medical Devices
As of 26 May 2021 the following medical devices have to be notified to Swissmedic:
Custom-made devices according to art. 19 MedDO of 1 July 2020. The notification obligation applies to persons (manufacturers, authorized representatives, importers or distributors) based in Switzerland prior to making such devices available on the market.
Repackaged or relabeled medical devices according to art. 53 or 54 MedDO of 1 July 2020. The notification obligation applies to persons (importers and distributors) based in Switzerland prior to placing such devices on the market.
Medical devices manufactured and used in health institutions according to art. 18 MedDO of 1 July 2020. The notification obligation applies to health institutions based in Switzerland prior to putting such devices into service.
Class I medical devices according to art. 108 MedDO of 1 July 2020 in conjunction with art. 6 MedDO of 17 October 2001 (Status as of 1 August 2020). These are class I medical devices according to the Regulation (EU) 2017/745 (MDR) and class I medical devices according to the Directive 93/42/EEC, that fall under the classes Ir, IIa, IIb or III according to MDR. The notification obligation applies to manufacturers based in Switzerland prior to placing such devices on the market.
Systems and procedure packs according to art. 108 MedDO of 1 July 2020. The notification obligation applies to persons (assemblers) based in Switzerland that assemble systems or procedure packs prior to placing such devices on the market.
Devitalised human tissue according to art. 108 MedDO of 1 July 2020 or art. 103 MedDO of 1 July 2020.
Notification of In-Vitro Diagnostic Medical Devices (IVD)
Manufacturers domiciled in Switzerland are obliged to notify Swissmedic when they place IVDs on the market in Switzerland for the first time. The legal basis for this obligation is Art. 90 para. 1 of the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219) in conjunction with Art. 6 of the Medical Devices Ordinance of 17 October 2001 (oMedDO). Original copies of the standardised notification forms must be sent to Swissmedic, together with any other required additional documents.
IVDs in classes D, C, B and A sterile must be notified individually.
IVDs in class A (non-sterile) can be notified individually or as device groups.
Repackaged or relabelled IVDs, has the notification obligation, based on Art. 46 para. 4 and Art. 47 para. 4 IvDO, applies to persons (importers and distributors) domiciled in Switzerland before the IVDs are placed on the market.
IVDs manufactured and used in healthcare institutions, are concerns IVDs manufactured and used solely within a healthcare institution (in-house IVD) according to Art. 9 IvDO. In-house IVDs must be reported to Swissmedic according to Art. 10 IvDO. The notification obligation applies to healthcare institutions in Switzerland prior to putting the devices into service.
The notification obligation referred to in Art. 10 IvDO applies to the following (examples, list not exhaustive):
• Medical analytical test procedures developed in-house and implemented with own
(non-CE-marked) reagents (e.g. a PCR test procedure for detecting a certain analyte)
• Medical analytical test procedures based on standard procedures or published procedures
and implemented with own (non-CE-marked) reagents
• Test procedures acquired but not intended for medical use (e.g. „Research Use Only/RUO“ procedures) that were (further) developed by the healthcare institution for medical analytical use
• IVD instruments manufactured in-house
• IVD software developed in-house
The notification obligation referred to in Art. 10 IvDO does not apply to the following (examples, list not exhaustive):
Test procedures with CE-marked IVDs that are implemented according to the directions of the
• IVD manufacturers
• IVDs for performance studies
• Products for general laboratory use
• Products intended for research use only