Update on the import of old-law medical devices: Missing legal basis for the labelling of MDD products
On 30 November, you were advised of our 16 November meeting with the authorities. We informed you that the Directorate of the Federal Office of Public Health (FOPH / BAG) and the Directorate of the supervisory authority Swissmedic had not responded to Swiss Medtech's demands for the dismantling of import barriers, but had rather communicated their position that: (a) there is no current legal uncertainty for the medtech sector, (b) the EU has declared Article IV of the Medical Devices Mutual Recognition Agreement (MRA) between Switzerland and the European Union (EU) to be no longer applicable" (Editorial: amended 29.12.2021), (c) legal basis does exist to require relabelling of medical devices covered by the old legislation (MDD products), and (d) there is no reason to remove existing import obstacles as a precautionary measure to ensure availability of medical devices. We also informed you that, in view of the unsuccessful talks with the authorities, Swiss Medtech would explore further measures to advocate for the interests of the industry and to counteract the threatening supply problems.
We would now like to inform you about the latest developments:
Meeting of the Joint Committee on the MRA: No progress made
At Switzerland's request, a meeting of the Joint Committee on the MRA took place on 1 December 2021 to discuss «differences of opinion regarding application of the MRA». As SECO's media release made no mention of an outcome, we assumed that no significant progress was made regarding an MRA update, or clarification about differences of opinion on its application. Our enquiry with SECO confirmed this.
Position of the Swiss Federal Council: The MRA is still applicable
In the current National Council (Nationalrat) winter session, the Federal Council (Bundesrat) has already answered several questions concerning MRA applicability for medical devices covered by the old legislation. In each case – as in the past response to interpellation 21.3499 «Non-updating of the Mutual Recognition Agreement. Implications» – it confirmed its position that the relevant regulations on old-law devices are provided for in the existing MRA and that, from Switzerland's point of view, the MRA remains applicable. See, among other things, the Federal Council's response to the question by National Councillor Kathrin Bertschy 21.8247 «Mutual Recognition Agreement (MRA) between Switzerland and the EU no longer applicable: What is the Federal Council's strategy?»
«It can be noted that the Swiss government has repeatedly and publicly communicated that the MRA is still applicable.» (Editorial: amended 29.12.2021)
Expert opinion: Legal basis for labelling of MDD products is not provided
Swiss Medtech commissioned a legal investigation of issues related to the import of medical devices covered by old legislation (MDD products). The authors main points were:
- The MRA remains valid and applicable. There has been no official notification of termination or suspension.
- There is no legal obligation to name the authorised representative (CH-REP) on the labelling, or elsewhere.
Full Legal Opinion (in German)
It can be stated that the Swissmedic «Obligations for Economic Operators CH» (German original: Pflichten Wirtschaftsakteure CH) information sheet contains no legal basis which would require labelling to include the Swiss authorised representative for products subject to the old legislation (MDD products).
From the Board of Directors
Swiss Medtech’s Board supports the Federal Council’s position that the MRA is still applicable, and – strengthened by various legal opinions – will work with unwavering commitment to enforce it in the interest of the industry and patient care. The Board will decide on further measures at the beginning of January 2022 if the Association does not reach a pragmatic solution with the authorities in the next few weeks. In the meantime, every company must independently decide if and how it will incorporate the Federal Council’s official position and the other legal opinions when planning their business strategy.
We will keep you informed about any further events or developments.
Swiss Medtech represents more than 750 members in its role as industry association for Swiss medical technology. With 67,500 employees and a contribution of 11.5% to the positive trade balance, medical technology is an economically significant sector in Switzerland. Swiss Medtech advocates for conditions that enable the medtech industry to perform at peak capacity and provide first-class medical care.