6.4.2020 – Exceptional authorisations for medical devices not conforming to CE standards: According to Art. 4n COVID-19 Ordinance 2 (SR 818.101.24, as of 4.4.2020), Swissmedic can authorise exceptional authorisations for the placing on the market and putting into service of medical devices for which no conformity assessment procedure has been carried out in accordance with Article 10 of the Medical Devices Ordinance of 17 October 2001 (SR 812.213, MepV). More
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
26.3.2020 – #medtechagainstcovid19:MEDTECH – TOGETHER AGAINST CORONAVIRUS. For use in your mail signature JPG/PNG/Animation
25.3.2020 – MDR-Moratorium: With patient health and safety as a guiding principle, the Commission announced on 25 March 2020 that work on a proposal to postpone the application date of the Medical Devices Regulation (MDR) for one year is ongoing. The goal is to submit this proposal in early April so the Parliament and Council can adopt it by the end of May. This will take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis. More
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
29 April 2020 – Swiss Medtech survey: Medical technology industry does its homework. Presentation (in German) / Media release
24 April, 2020 – MDR postponement comes into force: The amendment to the Ordinance on Medical Devices (MDR) has now been published in the Official Journal of the European Union and comes into force immediately.You can view the text here.
17 April, 2020 – EU Parliament postpones date of application of the MDR to 26 May 2021: Swiss Medtech informs the Swiss medical technology industry about the consequences.More
3 April, 2020 – EU Commission wants to postpone MDR implementation by one year: In view of the coronavirus pandemic, Swiss Medtech considers the EU Commission proposal to postpone the Medical Devices Regulation (MDR) date of application by one year to be imperative. The Association hopes that the Council and Parliament will also promptly agree with the recommendation. Ensuring the supply of medical devices required for the general population is now top priority. Read more
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