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MedDO stands for Medical Device Ordinance and is a set of regulations applicable for the medical devices to be marketed in Switzerland. The Medical Device Ordinance (MedDO) is in force in Switzerland since January 1, 2002. This Ordinance was initially drafted to be in line with the European Council Directives 93/42/EEC (MDD), 90/385/EEC (AIMDD) and 98/79/EC (IVDD). Since then, the MedDO has been revised in multiple instances, the latest revision being made in 2021 to align with the EU Medical Device Regulation (EU) 2017/745.
What Are the Requirements of MedDO?
The MedDO details the Regulatory requirements to be complied by device manufacturers intending to place and market the medical devices in Switzerland. The MedDO requirements include:
- Appointing a Swiss Authorized Representative (Swiss Rep) for foreign manufacturers
- Registration of the Economic Operator
- Reporting of the serious incidents to Swissmedic
- Assignment of the UDI
- Notification of the device
What Are the Pre-Requisites, Roles and Responsibilities of a Swiss Rep?
Foreign manufacturers of the medical devices must appoint a Swiss Authorized Representative (Swiss AR) before placing the products in Switzerland. The Swiss Rep acts on the manufacturer’s behalf in the country and will be acting as a key contact person for Swissmedic and associated Authorities. Any legal entity or natural person situated in Switzerland can act as Swiss AR. The manufacturer and the representative must have an agreement in place. The Swiss AR is responsible for product safety and is liable for product defects.
Who Should Be Registered as per MedDO Regulations?
All the economic operators i.e., manufacturers, importers, authorized representative situated in Switzerland must register with the Swissmedic as per the Swiss Medical Device Ordinance regulations. The activity of registering should be done within the first three (03) months of placing the device on the Swiss market. For economic operators who already sold products before May 26, 2021, in accordance with the MDR 2017/745 & IVDR 2017/ 746, the registrations in accordance must be completed by November 26, 2021. After successful registration, they will be assigned with Swiss Single Registration Number (CHRN). The Swiss Single Registration Number (CHRN) is a unique identification number to identify a manufacturer, authorised representative or importer.
What Is CHRN and What Is Its Role in Medical Device Regulation in Switzerland?
The economic operators shall submit the registration form “Application registration CHRN” along with the required information to Swissmedic. The application form and the information will be reviewed by Swissmedic and if found satisfactory, a Swiss Single Registration Number (CHRN), which is a unique identification number will be issued. The Agency fees varies with the amount of review work done by Swissmedic, per application and for assignment of CHRN. The fees will be charged on an hourly basis and Swissmedic charges CHF 200 per hour.
How Can a Device Be Registered with Swissmedic?
The Swiss MedDO requires the manufacturers to notify the medical devices to Swissmedic before they are placed in the Switzerland market. The Class I devices, custom made devices, systems and procedure packs, devitalized human tissue, repacked or relabeled medical devices, medical devices manufactured and used in health institutions in Swiss, IVDs and self-testing IVDs, and IVDs manufactured in-house shall be notified by the responsible stakeholders. The duly filled notification form along with the supportive information must be submitted to Swissmedic.
What Are the UDI Requirements Under MedDO?
The manufacturer shall comply with all the UDI requirements including UDI assignment (Basic UDI-DI), registration in the EUDAMED database and the placement of the UDI carrier on the label of the device or on its packaging or, in case of reusable devices, on the device itself (direct marking).
What Are the Incident Reporting Requirements of MedDO?
All the serious incidents that have occurred in Switzerland must be reported to Swissmedic by writing to materiovigilance@swissmedic.ch. The medical device manufacturers placing the devices in Switzerland are responsible for reporting the incidents. In case of foreign manufacturers, the Swiss Authorized representative shall submit the incident report. The incidents should be reported as per the criteria defined in Article 87 of the EU MDR.
Criteria | Reporting Requirements as per Article 87 of the EU MDR |
| Serious Public Health Threat | Report immediately but not more than 2 days |
| Death or unanticipated Serious deterioration in State of Health | Report immediately but not more than 10 days |
| Others (could have been death or serious deterioration in health) | Report immediately but not more than 15 days |
Can CE Marked Devices Be Marketed in Switzerland?
The CE marked devices can be marketed in Switzerland, if the applied conformity assessment procedures are in line with Swiss requirements and if the CE certificate is issued by a notified body, which is equivalent to what is described in the Medical Device Ordinance (MedDO).
Would you like to gain comprehensive insights on Medical Device Ordinance (MedDO) and its importance for placing medical devices in the Swiss market? Reach out to a Regulatory expert for end-to-end medical devices and IVD Regulatory services in Switzerland.