Last week, the European Parliament approved at first reading a legislative proposal (the Amending Regulation) to postpone the Date of Application of the new Medical Devices Regulation (MDR) by one year, to 26 May 2021. In accordance with EU legislative procedure, substantially all that remains now is for the Council of the European Union to approve the Amending Regulation and for it to be published in the Official Journal of the European Union, at which point it will become law and the Date of Application will be postponed.
Based on preparatory documents released by the Council, it is now fully expected that the Amending Regulation will become law in the very near future (something which we are keeping an eye on here at Bristows). This means the current Medical Device Directive (MDD) will almost certainly remain in force for an additional year.
This change is important for all businesses concerned with medical devices in Europe. Preparedness for the MDR has been a problem for a long time, so the postponement will give some valuable additional breathing room, and ensure vital medical supplies can continue to be placed on the market without disruption during COVID-19. However, the postponement is perhaps of particular importance for medical device companies with parts of their supply chain located in Switzerland. This is because of “Swixit”, something we’ve written about previously for On The Pulse.
In summary, Swiss-approved medical devices can currently be placed on the market in the European Union while the MDD remains in force because of a Mutual Recognition Agreement (MRA) between Switzerland and the European Union, which recognises medical device conformity assessment standards in those territories as equivalent. The MRA needs to be updated once the MDR enters into full force on the Date of Application and repeals the MDD. However, due to political friction between Switzerland and the EU, no agreement to update the MRA has yet been reached. As a result, for the purposes of the EU medical devices regulatory regime, Switzerland will become a third country on the Date of Application of the MDR. This means that Swiss manufacturers will need to revisit their EU supply and distribution chains. By way of example, a Swiss manufacturer must appoint an EU authorised representative and may need to appoint an Importer (if the devices are manufactured in Switzerland). Further, devices approved by a Swiss notified body will need to be assessed by an EU notified body.
Any postponement to the Date of Application buys more time before “Swixit” happens. As a result, Swiss Medtech has also been monitoring the progress of the Amending Regulation. Following its approval by the European Parliament, they put out a press release on the subject which you can read in English here. Below are some of the key points they make:
- The new date of application of the MDR is 26 May 2021 (this is technically incorrect, for the reasons given at the start of this article);
- The current regulatory framework will remain in place until 26 May 2021, including the existing Mutual Recognition Agreement;
- So long as the current regulatory framework remains in place, Swiss-manufactured medical devices may be placed on the market in the EU, without manufacturers needing to fulfil non-member country requirements;
- Conformity assessments conducted by Swiss notified bodies will continue to be recognised in the EU until 26 May 2021;
- The postponement in no way guarantees that the MRA will be updated to take into account the repeal of the MDD.
- Swiss firms should use the additional time to prepare fully for the possibility of “Swixit”.
Swiss Medtech is right to emphasise the importance of preparedness. Postponing the Date of Application may buy more time for the EU and Switzerland to come to an agreement over the future of the MRA, but it does not resolve the underlying political issues.
Although the MDR postponement puts off “Swixit” and will allow Swiss manufacturers to continue selling devices in the EU on an equal basis with EU manufacturers for an additional year, it does not have the same effect on Brexit and British manufacturers. This is because the legal mechanics of the UK’s departure from the EU are different from those underlying Switzerland’s potential “exit” from the EU medical device regulatory regime. Barring unforeseen developments, the UK will still complete its departure from the EU and become a third country to the EU medical device regulatory regime at midnight on 31 December 2020.