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Medical Devices - Free Market Access between European Union and Switzerland Given Blow

  • 31/05/2021
  • Articles

Regulation (EU) 2017/745, the new Medical Device Regulation (MDR), started to apply on 26 May 2021, more than four years after its adoption in April 2017. However, this important step in the development of the regulatory framework governing medical devices coincided with a shrinking of the internal market for these products as trade in medical devices between the European Union (EU) and Switzerland became subject to more red tape.
This is because the chapter covering medical devices of the EU – Switzerland Mutual Recognition Agreement (MRA) has not been updated to reflect the application of the MDR (see, the attached European Commission Notice to Stakeholders – the Notice). The failure to modernise the MRA is ironic, because both sides have tightened their requirements with respect to medical devices, mainly to improve safety and increase regulatory oversight. Even though the regulatory adjustments to EU and Swiss medical device rules are thus largely comparable, reciprocal free market access has fallen by the wayside because of the EU’s insistence that no piecemeal regulatory adaptations in areas of mutual interest will be made as long as the parties do not agree on an overarching Institutional Framework Agreement (IFA). Negotiations in pursuit of the IFA started in 2014, but were terminated by Switzerland on 26 May 2021, which thus added further complications to an eventful day.
The EU and Switzerland apparently anticipated these developments and, based on a proposal submitted by the European Commission, have tried to work out transitional arrangements for the MRA, including a grace period until 2024, but these talks failed as well.
The consequences for the EU-Swiss trade in medical devices are devastating as Switzerland exports more than EUR 4.5bn worth of medical devices to the EU, while it imports over EUR 2.4bn. Even though this trade will not dry up, it will become harder to sustain. Similarly, investment decisions, primarily those directed at Switzerland, may also be affected.
Industry will have to contend with additional expenses because the trade facilitating measures of the MRA no longer apply. Market surveillance will also be adversely affected. And new regulatory burdens will emerge.
For its part, Switzerland has put in place measures to mitigate these negative effects. For example, the measures will ensure the equivalence of the Swiss rules governing medical devices to those of the EU. Additionally, importers in Switzerland will be given time to appoint an authorised representative, adjust labelling, carry out registrations with Swissmedic, the Swiss regulatory authority, and effect specific publications.
Conversely, there are no transitional rules that apply to importers in the EU. As a result and as explained in the Notice, since 26 May 2021, these businesses are required to: 

  • ensure that medical devices are certified by an EU conformity assessment body if such a certification is dictated by the applicable conformity assessment procedure;
  • designate an EU authorised representative;
  • observe the rules governing the registration and labelling of products.


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    • 11/06/2021
    • Articles

    Belgium - Constitutional Court Rejects Challenge to Statutory Medicine Shortage Rules, Including Export Restrictions

    The Constitutional Court dismissed on 10 June 2021 the action which the Belgian Association of Parallel Importers and Exporters, several other parties active in the parallel trade in medicines, and pharmacists in the Democratic Republic of the Congo and Rwanda (the Applicants) had brought to obtain the annulment of Articles 2, 3 and 4 of the Law of 20 December 2019 modifying various laws to tackle medicine shortages (Wet van 20 december 2019 tot wijziging van diverse wetgevingen wat de tekorten aan geneesmiddelen betreft/Loi du 20 décembre 2020 modifiant diverses législations, en ce qui concerne les pénuries de médicaments – the Law). The Constitutional Court had already rejected a request for suspension of the same provisions (see, Van Bael & Bellis News and Insights of 20 July 2020). Yesterday’s judgment (see, attachments) focused on the powers given by statute to the government to establish a procedure for the creation of a temporary limitation or prohibition of the exportation of medicines that are unavailable on the Belgian market. The Applicants relied on the European free movement of goods principles but also on several provisions of Belgian law to challenge these restrictions. However, the Constitutional Court considered the contested rules justified in that they permit the government to counter situations in which medicine supplies to Belgian patients are no longer guaranteed. The Constitutional Court distinguished the new rules, which will be applied on a case-by-case basis following an assessment of the causes and nature of the particular shortage afflicting a specific medicine, from the blanket export prohibition imposed on wholesaler-distributors which it struck down in 2019 (see, Van Bael & Bellis Life Sciences News and Insights of 19 July 2019 and 17 October 2019). As the Constitutional Court has allowed the challenged statutory medicine shortage rules to stand, the question arises when the government will come up with the requisite implementing rules. Pressed on the subject in Parliament, the Minister of Social Affairs and Public Health indicated back in February 2021 that these proposed rules are under review, but he did not give a timetable for their adoption. Four months later, it is still not clear when they will become law.

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