New federal ordinance on medical devices (MedDo)

Explanatory summary and what Oroxus Sàrl can do for you.

09.02.2022

The Medical Device Regulation (MDR), or EU Regulation 2017/745, is a new European regulatory framework for medical devices that replaces the previous Medical Device Directive (MDD). While the MDD is a directive (a document of recommendations) that leaves some freedom to national governments to enact their own laws, the new MDR is a regulation (a strict law).

Switzerland is not a member of the EU. However, an Agreement on Mutual Recognition in relation to conformity assessment was concluded in 1999 as part of the bilateral agreements with the EU. This agreement regulates the recognition in the importing state of conformity assessments carried out in the exporting state. Conformity assessment verifies whether a product complies with the applicable requirements and can be placed on the market. The MRA ensures that the necessary certification processes only have to be carried out once and that the product can be placed on both markets on the basis of this certification. In addition, it provides economic operators with market access similar to that of their Swiss, EU or EEA competitors in 20 product areas, including medical devices.

On 26 May 2021, the Swiss government has buried the institutional framework agreement that Brussels has been calling for since 2008.

For the implementation of the MDR, the European Commission's supervisory authority did not wait for Switzerland and set up EUDAMED. This is the identification system for devices, the IUD, which is integrated into the shared database EUDAMED ("European Databank on Medical Device"). This European database is made up of six modules, one of which is dedicated to Medical Devices, in connection with the IUD. Thus, EUDAMED centralises all the information concerning medical devices present on the internal market and identifies all the economic operators as well as their role (manufacturer, importer, agent). This information is provided by the manufacturers who, in return, have access to all or part of the data held by EUDAMED for consultation and use.

With regard to the Swiss economic players, the Federal Council  (Swiss national executive) could not wait for the political resolution of the MRA problem. He therefore enacted the Ordinance on Medical Devices (MedDo) and mandated SWISSMEDIC, its authority for the supervision and authorisation of therapeutic products, to set up a system in Switzerland that is similar in every respect to that of the MDR with EUDAMED. Thus, when the negotiations between the EU and Switzerland are concluded, the processes will be so similar that the transition will be much smoother. The ODim is ultimately intended to make Swiss processes "euro-compatible".

This measure is therefore transitional and will disappear in the medium term.

The implementation of the MedDo is based on the implementation of the MDR (Art 87 MDR). The deadlines for manufacturers located in an EU/EEA country or with an authorised representative in an EU/EEA country (for manufacturers outside the EU) are as follows:
• High-risk medical devices (implantable Class III or IIb devices, AIMDs): 31 December 2021;
• Medium-risk devices (non-implantable Class IIb or Class IIa devices): 31 March 2022;
• Low-risk devices (Class I): 31 July 2022;
• Systems and processing units: 31 July 2022.
All other foreign manufacturers are subject to the obligation to appoint a Swiss authorised representative from 26 May 2021. From 26 May 2021, the Swiss importer must also be indicated on the device, on its packaging or in a document accompanying the device.

As a medical device manufacturer, you have had to comply with the MDR. Most of the work is done. All that remains is for you to:
1. Appoint a Swiss authorised representative (CH REP). ATTENTION: The Swiss authorised representative is not an importer or exclusive distributor. His role is to ensure on your behalf that all commercial dealings with your commercial devices on Swiss territory comply with the MedDo. 
2. Conclude a mandate contract with him.
3. Agree with him on the MedDo application.

The cost of a Swiss authorised representative is the result of an estimate. This estimate takes into account the costs that the authorised representative must bear in order to fulfil his responsibilities (administrative procedures, liability insurance, remuneration, possible flow of documents and samples). It is an estimate because the authorised representative has no control over possible changes in insurance conditions or changes in the costs of administrative procedures.
If, following the quotation, you agree to appoint Oroxus Ltd as your Swiss authorised representative, Oroxus Ltd will send you a draft authorised representative agreement which will form the basis of any approach to SWISSMEDIC.