Challenges for Swiss manufacturers of medical devices and in vitro diagnostics in the area of Regulatory Affairs and New MDR and IVDR transition periods

2022 was an exciting year for the international medical device industry. EU manufacturers had to implement the requirements of the Medical Device Regulation (EU) 2017/745 (MDR), while in vitro diagnostics (IVD) manufacturers were faced with the introduction of the EU In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR) and had to update their technical documentation for in vitro diagnostic devices. With Brexit (UK) and the end of the Mutual Recognition Agreement (MRA) with Switzerland, both the UK and Switzerland have effectively become third countries. This has a significant impact on the regulatory compliance for medical devices and in vitro diagnostics placed on the market in the UK and Switzerland.

What does this mean for Swiss medical device and in vitro diagnostic manufacturers? In this article, we would like to give you an overview of the most important developments relevant to you.

Failure to update the Mutual Recognition Agreement (MRA) and consequences for Swiss manufacturers

Since Chapter 4 (Medical Devices) of the Agreement between the European Community and the Swiss Confederation on Mutual Recognition in relation to Conformity Assessment (MRA, SR 0.946.526.81) has not been adapted and extended under the MDR and IVDR, Swiss manufacturers of medical devices and in vitro diagnostic medical devices (IVDs) must now meet additional requirements to demonstrate conformity with EU requirements before they can place their products on the European market. Here is an overview of the most important steps:

1. Conformity assessment according to EU regulations Swiss manufacturers must assess their products according to the EU Regulations on Medical Devices (EU 2017/745; MDR) and In Vitro Diagnostic Medical Devices (EU 2017/746; IVDD) and ensure that they comply with the respective regulatory compliance. This includes the preparation of technical documentation and the implementation of quality management systems in accordance with the requirements of the MDR/IVDR.
2. Appointment of a European Authorized Representative (EU-REP): Swiss manufacturers must appoint a natural resident or legal person in the EU. This person acts as the manufacturer's contact and representative in the EU and assumes certain obligations on behalf of the manufacturer, such as cooperation with the competent authorities.
3. Labeling update: Product labeling must be in accordance with EU regulatory compliance. This includes, but is not limited to, the affixing of the CE marking (if applicable), the identification of the European Authorized Representative, product labeling as required by the MDR/IVDR and the provision of instructions for use, and product information in the required official languages of the EU target market.
4. Submission to a Notified Body: Depending on the risk class of the devices, Swiss manufacturers must submit their devices to a Notified Body in the EU for conformity assessment. The Notified Body examines the technical documentation and confirms the conformity of the device with the requirements of the MDR/IVDR. Collaboration with a recognized Notified Body is mandatory for certain classes of medical devices and in vitro diagnostics (IVDs). In addition, depending on the class of medical device or IVD, a certified quality management system that also meets the requirements of the MDR/IVDR is required.
5. Preparation of a Declaration of Conformity: Swiss manufacturers must draw up a declaration of conformity confirming that their device complies with the regulatory compliance of the IVDR/MDR. This declaration must be submitted with the technical documentation and accompany the device.

It is important to note that these steps may vary depending on the product and risk class. As a Swiss manufacturer, you should therefore check the exact requirements of the MDR/IVDR for your specific products and, if necessary, seek assistance from experts or consultants to ensure that you implement all the required steps correctly.

Compliance with EU regulatory compliance is essential to ensure access to the European market and to legally place products on the market. With careful planning and implementation, you can efficiently complete the necessary conformity assessment steps and successfully market your products in the EU.

Impact of Brexit

Brexit also has significant implications for manufacturers in Switzerland. Prior to Brexit, medical devices and in vitro diagnostic devices (IVDs) that were legally marketed in the EU and carried a CE mark could also be marketed in the UK. This will change at the end of the transition period on 30 June 2023. From 1 July 2023, UKCA marking will be required for medical devices and in vitro diagnostics to be placed on the UK market.

New MDR and IVDR transition periods

However, new transition periods have been introduced to give manufacturers more time to adapt. The European Commission published a proposal to amend the Medical Devices Regulation (EU 2017/745, MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU 2017/746, IVDR). This proposal has been adopted by the EU Council and the European Parliament and allows for an extension of the transition periods. Higher-risk Class III and Class IIb devices now have until 2027 to transition to the MDR, while Class IIa and Class I devices requiring the involvement of a Notified Body have until 2028.

If you are a Swiss medical device/ In Vitro Diagnostics (IVD) manufacturer, it is important to know that the new transition periods do not automatically apply to all devices. They are subject to certain conditions. Devices must continue to meet regulatory requirements, must not have undergone significant changes, and you must have already initiated a conformity assessment process under the MDR/IVDR. It is advisable to start the transition to the new regulations as early as possible to avoid bottlenecks.

Summary

The end of the Mutual Recognition Agreement (MRA) has important implications for Swiss-based medical device and in vitro diagnostic manufacturers, who will now need to take additional steps to distribute their products in the European market. Brexit also has an impact, as UKCA labeling will be required for the distribution of products in the UK from 1 July 2023. The new transition periods for the MDR (EU 2017/745) and IVDR (EU 2017/746) give you, as a manufacturer, more time to transition, but require timely planning and implementation.

We encourage you to address these issues early and are happy to assist you with the regulatory challenges for your medical devices and in vitro diagnostics (IVD).

Please do not hesitate to contact us - we look forward to meeting you!