IVD (in-vitro diagnostic) medical devices
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. The following documents should be submitted to Swissmedic:
- certification documents relating to the conformity assessment procedures (EC certificates), and
- the instructions for use plus – in the case of devices for self-testing and for near-patient testing –the layout of the outer packaging.
IVDs in class A (non-sterile) can be notified individually or as device groups. The following form for this purpose must be submitted to Swissmedic:
Repackaged or relabelled IVDs
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. The following form for this purpose must be submitted to Swissmedic:
The product list template for notifying a device group can be downloaded here:
IVDs manufactured and used in healthcare institutions
This 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
Document MDCG 2023-1 on the European Commission website (Guidance - MDCG endorsed documents and other guidance (europa.eu)) contains further information on in-house IVDs.
The following form (guidelines for completion: see FAQ) must be sent to Swissmedic:
The product list template for notifying a device group can be downloaded here:
