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.
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.
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
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.