EU MDR Regulation

Two weeks ago, Pegah Kiani, introduced the soon to be implemented EU MDR Regulation. In this article, she looks at the possibility of Switzerland and Turkey ‘exiting’ and the impact on regulatory professionals.

BREXIT

Brexit has affected the regulatory landscape for the medical device and pharmaceutical industry and regulatory processes have had to be amended to adhere to these. Great Britain (GB) will not adopt the EU Medical Device Regulation (2017/745), but Northern Ireland (NI) has and the date of application of EU MDR (26 May 2021) will apply for NI. Consequently, the UK Medical Devices Regulation 2002 was amended to add specific requirements in a post Brexit world. But as we continue to find ourselves in a forever changing regulatory landscape, it’s perhaps no surprise that other countries such as Switzerland and Turkey are following suit in terms of regulatory ‘exit’ changes.

Status of Swiss-exit and Turkey-exit

Switzerland is not part of the EU but is bound to the Union through a series of agreements. There is, for example, a Mutual Recognition Agreement (MRA) covering medical devices in order to enable these devices to move freely between the EU and Swiss markets. There are over 120 MRAs linked to a wider framework agreement. In the view of the European Commission, the current MRA that includes medical devices does not cover the upcoming EU Medical Device Regulation (2017/745). As a result, access to the markets could become considerably more difficult for both sides. If the MRA between Switzerland and the EU is not updated, there is a risk of Switzerland being deemed a third country from the EU’s point of view as of 26 May 2021. This would mean, for example, that Swiss medical device manufacturers would need to have an authorised representative/importer in the EU, in order to place medical devices on the EU market.

Switzerland

The currents status indicates that ‘Swixit’ will happen in May 2021. Switzerland and the EU will not be aligned on the Institutional Framework Agreement before the date of application of EU MDR (2017/745). This means that Switzerland is out of the Union for the purpose of the MDR in May 2021. However, this does not mean that Switzerland is out of the In-vitro Diagnostic Medical Devices Regulation (IVDR) Union. It is questionable whether the MRA for the (EU IVDR 2017/746) will be signed on its date of application in May 2022. If the Institutional Framework Agreement has not been signed by May 2022, then it will also be ‘Swixit’ for In-vitro Diagnostic Medical Devices.

Turkey

To complicate matters further, Turkey also requires CE marking for placing of medical devices on the market, although Turkey is neither a member of the EU nor part of the European Economic Area (EEA). Due to bilateral agreements with the EU, Turkey has a similar status to European Free Trade Association (EFTA) countries regarding the MDR. The Turkish Medicines and Medical Devices Agency (TITCK) issued an announcement about the MDR delay but has not specified whether it plans to take any actions in response. One can say that ‘Turkxit’ could look like ‘Swixit’ from a legal perspective and that by 26 May 2021, medical devices could be exiting.

Next Steps

If the MRA between Switzerland and the EU is not updated by 26 May 2021, Switzerland will be considered a third country for medical devices. This scenario needs to be considered a serious prospect and preparations need to be made. Without a follow-up to the MRA, all foreign manufacturers from May 2021 need to establish some changes. The revised Swiss Medical Devices Ordinance provides requirements for the import of medical devices, namely the designation of an importer and a Swiss representative to ensure that foreign manufacturers continue to place medical devices in Switzerland. This is because Switzerland will lose barrier-free access to the EU internal market for medical devices. Therefore, Switzerland will be treated as a third country. Conversely, all Swiss manufacturers will need to designate an importer and an EU representative in a Member State to continue supplying medical devices to the EU.

The Impact

The need for new compliance infrastructure requires the need to have more formalities in order to market medical devices in countries like UK and Switzerland, while in tandem setting up regulatory processes to meet the EU MDR. Hence, various considerations need to be made to make sure that from a regulatory perspective all these new requirements are met.

How Can We Help?

We continue to monitor the situation and the developments on the next regulatory framework, which could lead to Switzerland becoming a third country for the Union and Turkey not adopting the EU MDR. S-cubed can offer regulatory help and support for medical devices. You can contact us through our website or via email (info@s-cubed-global.com).



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