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1 April 2021 - Information from the industry (Important contents of the Contingency MedDO)

On behalf of the Federal Council, the Federal Office of Public Health (FOPH) has prepared an amendment to the Medical Devices Ordinance (“Contingency MedDO”) as a precautionary measure, which will be put into force by the Federal Council on 26 May 2021 if the Mutual Recognition Agreement (MRA) between Switzerland and the European Union (EU) has not been updated by that date. Swiss Medtech is in regular contact with the FOPH regarding the Contingency MedDO. Due to the time pressure under which the Swiss medical technology industry is operating, we would like to inform you about some important contents of the Contingency MedDO. Please note that an update of the MRA before 26 May 2021 is not excluded. In that case, the Contingency MedDO would not enter into force.

Background information

16 February 2021 - Information for the industry

On 26 May 2021 the European Medical Device Regulation (MDR) will come into force, the same day that the corresponding Swiss Medical Device Ordinance (MedDO) enters into effect. All stakeholders must be aware that the Mutual Recognition Agreement (MRA) between Switzerland and the European Union (EU) will probably not be updated by 26 May 2021. Regardless of all our efforts, Switzerland will probably become a third country in the area of medical devices on 26 May 2021. We offer practical assistance for the third country scenario:

Swiss manufacturers 

Guidance for Swiss Manufactures (in German)

Order Contract Template for EU Authorised Representative
(free for members, CHF 100.00 for non-members)

Swiss Distributors and Importers

Guidance for Swiss Distributors and Importers 

Information on importing medical devices into Switzerland

Order Contract Template for Swiss Authorised Representative
(free for members, CHF 100.00 for non-members)

5 February 2021 – Patient care is at risk

Swiss Medtech has drawn the attention of important Swiss healthcare players to the impending supply shortage of medical devices. The worrying situation is still far too little noticed. We appeal to the joint responsibility of all actors in the healthcare sector to pay due attention to the problem and to exert influence with decision-makers in order to avoid negative effects on patient care in Switzerland.Background information (in German)

1 February 2021 – Information to all Swiss importers and distributors of medical devices

We have supplemented the documents for the information of 16 December 2020. You will now find the guidance also in German and French, as well as a 1-pager in the three languages that you can send to your foreign manufacturers.

Guidance for Swiss Distributors and Importers

Information on importing medical devices into Switzerland

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.

More information

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:

Information for the industryInstructions for Swiss Manufacturers (in German) Instructions for Swiss Distributors and Importers«MDR Readiness Q&A» Webinar Series

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.

More information

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.

More information

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.

Instructions for Swiss Manufacturers (in German)

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.