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.