25 January 2021 – 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.
6 January 2021 – Publication of the expert names
The MDR requires the European Commission to create expert panels to support the scientific assessment and advice in the field of medical devices. Amongst others, the panels of experts will provide an opinion on the notified bodies’ assessments of clinical evaluation of certain high-risk medical devices. The European Commission has published the names of the experts.
16 December 2020 – Information for all Swiss manufacturers and distributors of medical devices
The European Medical Device Regulation (MDR) will come into force in less than six months – on 26 May 2021 – the same day that the corresponding Swiss Medical Device Regulation (MepV) enters into effect. The decision to adapt to the third-country requirements must be made by each company individually. In our function as an industry association, however, we are available to provide advice and support and would like to offer the following assistance:
3 December 2020 – European Commission’s EUDAMED database
The European Commission’s EUDAMED database, a critical component of the MDR, was launched with the actor registration module. At present, economic operators established in the EU or European authorized representatives may register. Economic operators based in Switzerland will NOT be able to register until an agreement between Switzerland and the EU can be reached.
19 November 2020 – Harmonised standards under MDR
A request for harmonisation of standards was submitted to the European Commission for adoption and submission to the European Committee for Standardization and the European Committee for Electrotechnical Standardization (CEN/CENELEC). Annex I contains a list of 151 existing and 28 new standards with deadlines for their adoption.
16 November 2020 – «Language implications of MDR for labelling of Medical Devices»
Medtech Europa has updated the overview of the «Language implications of MDR for labelling of Medical Devices».
12 November 2020 – Medtech Europe Guidance on «MDR requirements on hazardous substances»
The Medtech Europe Guidance on «MDR requirements on hazardous substances» has been approved by the Risk Assessment Committee (RAC) of the European Chemical Agency (ECHA) and is now valid.
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.
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.