The Mutual Recognition Agreement (MRA) facilitated bilateral trade between Switzerland & the EU, avoiding the technical barriers that were lapsed on May 26, 2021. Replacing the MDD (93/42/EEC) and AIMDD (90/385/EEC), the Medical Device Regulation (EU 2017/745) has also come into effect from May 26, 2021. Similarly, the Swissmedic’s revised Medical Device Ordinance (MedDO) has also come into force on May 26, 2021, with requirements similar to the EU MDR.
Under the Swiss MedDO, Swissmedic mandates non-Swiss manufacturers (located outside Switzerland and without any local business offices) to appoint a Swiss Authorized Representative (CH-Rep) or Swiss AR or Swiss Rep on their behalf as a pre-requisite for device registration and launch in Switzerland.
Role of a Swiss AR
According to Swiss Medtech, the Swiss Representative shall register medical devices with Swissmedic on behalf of the manufacturer, ensure conformity of the device, respond to any queries from Swissmedic and carry out Post-Marketing Surveillance (PMS) activities.
The Swiss Representative obligations include the following:
- Must act on behalf of the foreign manufacturer and register the devices with MedDO
- Verify the declaration of conformity and the technical documentation
- Verify if appropriate conformity assessment procedures have been carried out by the manufacturer
- Verify that the manufacturer has complied with the registration obligations
- Keep a copy of the technical documentation, the declaration of conformity, relevant certificates along with any amendments and supplements
- In response to a request from Swissmedic, provide information and documentation necessary to demonstrate the conformity of a device
- Forward Swissmedic request for samples or access to a device and ensure Swissmedic receives the samples or is given access to the device
- Cooperate with Swissmedic on any preventive or corrective action or FSCA’s
- Immediately inform the manufacturer about any complaints and reports received from the market
Foreign manufacturers other than the EU/EEA countries must appoint a Swiss AR by May 26, 2021. The EEA and the EU-based countries have various grace periods for different risk classes of the devices till July 31, 2022.
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