MDR Portal

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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?». 
More information

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.

More information (in German)

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.

Guidelines (in German only)

29 April 2020 – Swiss Medtech Survey about MDR Readyness

Medical technology industry does its homework.
Press release 

Presentation Survey results (in German only)

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. 

2 March 2020 – Update of the online versions of MDR and IVDR

The online consolidated versions of the MDR and IVDR have now been updated to reflect the changes of both corrigenda from 2019.

To the MDR online versionTo the IVDR online version

20 January 2020 – Information for Swiss manufacturers of medical devices

Update regarding the Institutional Agreement and the Mutual Recognition Agreement.