MDR Portal

Newsticker

7 October 2020 – manufacturers of Class I medical devices

To help manufacturers of Class I medical devices comply with MDR, the Irish HPRA has compiled a crystal-clear list of key activities to complete. For each activity, the document refers to the relevant articles in the legislation.

30 September 2020 – MedTech Europe has updated the IVDR/MDR implementation tracker.

This is a very helpful document as it shows you the state of EU documents and provides hyperlinks to directly access them. The document has two separate sections - one for published material and another for documents in the pipeline. We hope this structure helps you navigating throughout the document and get to the information you are looking for.

MTE tracking tool for MDR IVDR

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. 

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)

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.