Current topic Coronavirus

27.3.2020 – Export of medical protective gear subject to authorisation and introduction of Green Lanes: On 25 March 2020, the Federal Council decided to introduce authorisation requirement for the export of medical protective equipment. The corresponding amendment to COVID 19 Ordinance 2 came into force on 26 March 2020. There are exceptions to the authorisation requirement for exports to the EU and EFTA area. More (in german only)

26.3.2020 – #medtechagainstcovid19: MEDTECH – TOGETHER AGAINST CORONAVIRUS. For use in your mail signature JPG/PNG/Animation

25.3.2020 – swissmedic information: Towing to the current “extraordinary situation” in Switzerland, Swissmedic will guarantee that exemption applications are processed promptly and pragmatically. More

24.3.2020 – Swiss Association for Standardization (SNV): The SNV provides several covid-19 PSA and MD standards free of charge. More

23.3.2020 – MedTech Europe demands to pause the MDR implementation: In light of the COVID-19 pandemic and the medtech industry’s key role in combatting this outbreak, MedTech Europe (MTE) is formally requesting that the EU Institutions postpone the implementation of the IVD and Medical Devices Regulations (IVDR/MDR). Press release

 

As a member of the MTE, Swiss Medtech welcomes the motion. Maintaining maximum availability of all medical technologies necessary to keep health systems running during the fight against COVID-19 is now top priority.

20.3.2020 – Confirmation of classification of critical infrastructure and vital services: The Federal Office for Civil Protection (FOCP) confirms that the members of Swiss Medtech, as operators of a critical infrastructure, belong to the medical care sub-sector. They thus provide essential services for the health of the population, in particular for coping with the coronavirus pandemic.

 

The FOCP recommends that a letter be issued to all relevant staff, identifying them as important employees of the respective companies. This is in addition to the classification confirmation. For important cross-border commuters, the FOCP recommends that companies offer overnight accommodation in Switzerland if necessary.

20.3.2020 – EU export permit requirement for medical protective equipment abolished for Switzerland from 21 March 2020: Further information and the relevant amendment to the ordinance can be found on the website of the European Commission. More

 

In addition, the German Federal Office of Economics and Export Control also lifted its export ban as of 19 March 2020. More

17.3.2020 – Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures in connection with the COVID-19 threat. The EU is also allowing non-CE marked products within the internal market. More

Consequences for Swiss Medtech Events: Here is the latest status:

 

  • 1.4.2020 MDR&IVDR Conference: is rescheduled, new date 15.9.2020

  • 14.5.2020 Swiss Medtech General Meeting: is rescheduled, date to be defined

  • 9.6.2020 Swiss Medtech Day: is rescheduled, new date 21.9.2020

Tickets that were already purchased will be refunded in case of postponement or cancellation of an event.

 

Latest information: Federal Office of Public Health

MDR-News-Ticker

2 March, 2020 – News: the online consolidated versions of the IVDR and MDR have now been updated to reflect the changes of both corrigenda from 2019: IVDR und MDR.

20 January, 2020 – Information: for Swiss manufacturers of medical devices: Update regarding the Institutional Agreement and the Mutual Recognition Agreement. More

8 January, 2020 – MTE Information: Implementation Status of the MDR and Call to Action

27 December, 2019 – Publication: Corrigendum IIInfografik MTG

11 December, 2019 – Information: for Swiss manufacturers of medical devices: Update regarding the Institutional Agreement and the Mutual Recognition Agreement. More

3 December, 2019 – News: The ENVI Committee of the European Parliament has approved Corrigendum II (extension of the transitional period until May 2024 for up-classified Class I medical devices). More

11 November, 2019 – News: Open letter from the CAMD Executive Group to the medical devices community concerning EUDAMED delay. More

5 November, 2019 – News: EU Commission officially announces a two-year delay in the introduction of Eudamed. More

Swiss Medtech

Swiss Medical Technology Association

Freiburgstrasse 3
3010 Berne

Switzerland

Member of:

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