3 August 2020 – New online event «MDR@noon»
The webinar will be held every 3rd Wednesday of the month at noon, i.e. from 12.00 to 13.00h, The topics will cover all relevant regulatory aspects of the MDR. The event will be held in English. The next webinar will be held on 19 August treating the topic «Audit under MDR rules - QM acc. ISO 13485 or MDSAP?».
20 July 2020 – Training on «Standards in medical technology» (Aug. – Nov. 2020)
The Swiss Standards Association (SNV) and GS1 Switzerland offer seminars on MDR and UDI. Swiss Medtech members benefit from the same discount as SNV members.
13 July 2020 – Call for Action regarding «Virtual Audits»
Now is the right time to allow virtual audits – otherwise the time gained from the MDR postponement is wasted.
2 July 2020 – MDR & IVDR Conference postponed
The MDR & IVDR Conference planned for 15 September 2020 will be postponed to 25 March 2021 due to the postponement of the MDR and the current COVID-19 regulations.
MDR Online Conference
In its stead, a half-day online event in English will be held on 15 September 2020 on the topic «MDR and more – a Swiss Perspective». More informationen
15 May 2020 – Updated Swiss Medtech guidelines for compliance with third country requirements
Due to the postponement of the MDR start date to 26 May 2021, the Swiss Medtch guidelines were updated.
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 – Consequences of the MDR postponement
EU Parliament postpones date of application of the MDR to 26 May 2021. Swiss Medtech informs the Swiss medical technology industry about the consequences.
20 January 2020 – Information for Swiss manufacturers of medical devices
Update regarding the Institutional Agreement and the Mutual Recognition Agreement.
2019 MDR News
5 November 2019 – EU Commission officially announces a two-year delay in the introduction of Eudamed
7 June 2019 – Open questions remain for the medical technology industry
25 April 2019 – Third country scenario recommendations
Swiss Medtech recommendations to Swiss medical device manufacturers: prepare for the scenario of having to meet the requirements of a third country.