Medical devices
From 26 May 2022, it is mandatory that non-Swiss based manufacturers designate a Swiss-based Authorised Representative. This is a result of the Mutual Recognition Agreement on medical devices, between Switzerland & the European Union, not being updated with the IVDR. This caused Switzerland to become a third country and ended the mutual recognition.
- At Obelis, we …
- assume the role of Swiss Authorized Representative
- ensure technical documentations has been drawn up
- keep a copy of technical documentation readily available for inspection
- cooperate and provide SwissMedic all information upon request
- inform the manufacturer of complaints and incidents
- provide assistance for actor and device registration on Swissdamed (Swiss Database on Medical Devices)
- provide ongoing regulatory news and updates
Swiss law has clearly defined the role and tasks of a Swiss Authorised Representative, where professionalism and qualifications need to be at the same level of those under the EU IVDR. This means that it is highly recommended to designate a professional agency as Swiss Authorised Representative.
The deadlines to appoint a Swiss Authorized Representative (CH-REP) under the Medical Devices Ordinance for manufacturers established in an EU/EEA state or which have an Authorized Representative in an EU/EEA state are:
- Class D → December 31, 2022
- Class C & B → March 31, 2023
- Class A → July 31, 2023
Non-EU manufacturers who do not have an EAR must appoint a Swiss Authorized Representative immediately.
Economic operators – i.e., manufacturers, importers, authorised representatives – will have to register on the Swiss Database of Medical Devices (Swissdamed) to obtain a Swiss Single Registration Number (CHRN), which will serve as the identification number in diverse contexts and processes. Devices will also have to be registered on Swissdamed.
The database is expected to go-live in 2023.
Until Swissdamed is operative, only Economic Operators based in Switzerland need to register with Swissmedic to obtain the CHRN, in accordance with the deadline indicated below. Similarly, for the time being, only Swiss manufacturers must notify their devices to Swissmedic.
- Within 3 months following the placing of a device on the Swiss market.
- By 26 November 2022 for companies who have already placed IVDR compliant products on the Swiss market before 26 May 2022.
In-vitro diagnostics
From May 26, 2022, the agreement between Switzerland and the European Union on mutual recognition of in vitro diagnostic medical devices no longer applies. From this date, Switzerland is considered as a third country.
On May 4, 2022, Swiss legislator has officially adopted the new Swiss IVD Ordinance (IvDO). This means that IVD manufacturers need to be compliant with the new Swiss IVD Ordinance if they want to place IVDs on the Swiss market.
The deadlines to appoint a Swiss Authorized Representative (CH-REP) under the IvDO for manufacturers established in an EU/EEA state or which have an authorised representative in an EU/EEA state are:
- Class D → December 31, 2022
- Class C & B →March 31, 2023
- Class A → July 31, 2023
Non-EU manufacturers who do not have an EAR must appoint a Swiss Authorized Representative immediately.
Cosmetics
For the moment, EU Cosmetics Regulation should be followed to enter the Swiss market. Contact us for further details, or find more information here.
Compliance Success Stories
“We can always count on the quick response of the Obelis team. Managing the huge amount of data necessary for a EU Notification is very complex yet they make is seem so easy.”
“We were under huge time and cost pressure for a new product line launch and we relied on Obelis. It was the right decision. Their expert team helped us to avoid possible regulatory complications.”
“I encourage companies to seek compliance before putting their devices on the market. Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company.”
