The Medical Device situation in Switzerland is challenged by the agreement signed with the European Union.
Initially, EU and Switzerland signed a Mutual Recognition Agreement that included the EU MDD 93/42/EC. This permitted to Swiss medical device manufacturers to distribute their product in the EU without to appoint an authorized representative and without to have an importer.
The Mutual Recognition Agreement was not yet updated with the arrival of EU MDR 2017/745 which replace EU MDD 93/42/EC. Without a new Mutual Recognition Agreement, the Swiss companies will be considered outside of the Medical Device EU market from May 26th, 2021.
The legislation that will need to be followed is the Medical Devices Ordinance (MedDO). Any medical device manufacturer located outside Switzerland need to appoint an Authorised representative if they want to continue to distribute their product in Switzerland.
Definition of First Placing on the Market
“The first placing on the market is considered to be when a new device or a device which has been reprocessed or modified in such a way that it no longer serves its intended purpose or produces the intended performance is provided or transferred in Switzerland for the first time, either free of charge or subject to payment.
The first placing on the market is also considered to be the use by professionals of a medical device directly imported from a third country or of a medical device produced in house.”
How we can help?
Easy Medical Device located in Basel Switzerland is able to help you continue distributing your products in Switzerland by becoming your Swiss Authorised Representative.
- This service will comprise:
Cooperating with Swissmedic in the case a corrective or preventive action is required
- Verify if your company is compliant regarding the Swiss registration requirements under the MedDO.
- Storing a copy of your Technical Documentation and Declaration of conformity in case of national authority request
- Verifying that the labels of your device are fulfilling the Swiss requirements
- Ensuring Vigilance activities as reporting incidents to Swissmedic and providing complaints to the manufacturer.
Why should you work with us?
Easy Medical Device is also performing this service in the UK after Brexit. So we already know the activities to be performed.
For any question you can contact us at:
- Email: email@example.com
- Phone: +41 799036836
- Address: Bernoullistrasse 20 – 4056 Basel – Switzerland