Three Notable Government Developments: US UK, CH EU and Mercosur EU

By Luiz Levy, Annette Van Raamsdonk and Evangeline Loh

Emergo experts share three recent government developments of interest to medical device manufacturers marketing in the EU, UK, Switzerland, U.S., and Argentina, Brazil, Uruguay and Paraguay.  

Switzerland EU Mutual Recognition Agreement (MRA) Bilaterals III

The Swiss Federal Council (March 13) approved and adopted a package touted as “Stabilization and further development of Swiss-EU relations” (Bilaterals III, Federal Gazette No. 53 of 18 March 2026). Many elements of this exist and it “aims to consolidate sectoral participation in the EU single market.”

As part of this, a series of collateral have been posted, including 15 fact sheets. Factsheet05 discusses the Mutal Recognition Agreement and the importance of the EU legislation and the benefits to Switzerland, including, as an example, to medical devices and SwissMedic to be able to access market surveillance information from EU member states for medical devices.

While this still requires national procedures in Switzerland, including adoption by the Swiss Parliament, there is progress with the MRA.

UK and US regulatory cooperation on medical devices

The UK regulator, MHRA, announced a collaboration with the US FDA on medical devices (April 2), advancing an already-developed pharmaceutical partnership.

This is still in progress and options are being explored, including mechanisms for mutual recognition. Of course, both regulators will remain independent, though this will be interesting to monitor.

EU and Mercosur trade agreement

The EU and Mercosur (Argentina, Brazil, Uruguay, Paraguay) Trade Agreement was signed on January 17. The agreement aims to strengthen economic integration and establishes a framework for enhanced market access, regulatory cooperation and trade facilitation. The European Commission will proceed with provisional application of the agreement by May 1, and Argentina, Brazil, and Uruguay have submitted notifications and Paraguay will soon.

From a medical device and IVD perspective, the agreement is expected to reduce tariffs that currently impact the importation of EU‑manufactured products into Mercosur markets.

While the agreement does not replace existing regulatory compliance requirements, such as ANVISA authorization in Brazil, it is expected to improve transparency, predictability and cooperation in regulatory matters. Over time, this may contribute to streamlined conformity assessment processes, improved alignment with international standards and reduced administrative burdens for manufacturers.

Concluding remarks

These are all interesting developments that will favorably impact medical device manufacturers globally.