News | Swiss Medtech

01.07.21 Response to the consultation procedure

Statement regarding the IvDV and KlinV-Mep

Swiss Medtech firmly rejects both draft regulations and calls for a fundamental and comprehensive revision.

Information from Swissmedic about MedDO

If the manufacturer of a medical device does not have its registered place of business in Switzerland, its products may only be placed on the market once an authorised representative domiciled in Switzerland has been appointed (Art. 51 para. 1 MedDO). This also applies to manufacturers with their registered place of business in the EU. The transitional periods defined in Art. 104a MedDO apply to the authorised representative.
Here you can find further information on the Swiss authorised representative (CH-REP).

31.05.21 News

EU Commission Notice about MRA

On 26 May 2021, the EU Commission published a statement for stakeholders on the «Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for Medical Devices». They indicated that the mutual recognition and any associated facilitation of trade of medical devices between the EU and Switzerland ceases to apply as of 26 May 2021. The information from the EU Commission included the following points:

26.05.21 News

Federal Council breaks off InstA negotiations

The first domino has fallen

26.05.21 News

Information from Swissmedic about MedDO

Modification of the Medical Devices Ordinance (MedDO) in the context of pending agreements between Switzerland and the EU.

26.05.21 Press release

Swiss medtech downgraded to «third country» status today

Swiss medtech loses barrier-free access to EU single market

19.05.21 News

Information from the Federal Council about MedDO

At its meeting today, the Federal Council adopted the amending decree of the totally revised Medical Devices Ordinance. The date of entry into force is 26 May 2021.

04.05.21 News

Publications on the Swiss Authorised Representative

Streichenberg & Partner has written three interesting articles in PharmaCircular that provide you with useful information:

04.05.21 Press release

Swiss Medtech Award 2021: The finalists are confirmed

GalvoSurge Dental, icotec, and Scewo will compete for the prize

23.04.21 Press release

Swiss medical technology now calls for clear signs of goodwill (in German only)

Schwerwiegende negative Folgen sind dringend zu vermeiden

16.04.21 News

Swiss Medtech Day

Registration is open

01.04.21 News

Information for the Industry from Swiss Medtech

Important contents of the Contingency MedDO