The Council of the European Union on 2 November 2026 adopted an Amending Protocol to update the EU-Switzerland Mutual Recognition Agreement (MRA) on Conformity Assessment, aiming to modernise and stabilise the agreement to facilitate trade by ensuring mutual acceptance of product conformity assessments. The protocol will impact EU and Swiss manufacturers, particularly in the medical devices and gas appliances sectors, as well as national conformity assessment bodies and the Joint Committee overseeing the agreement.
Document Details and Scope
The protocol was adopted by the Council and updates core articles (Articles 1, 3, 9, 10, 11) and Annex 1 of the MRA. It references specific EU regulations, including Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2016/426 on appliances burning gaseous fuels, ensuring alignment with current EU legislation. The document is a legislative act that amends the existing agreement, making it mandatory for both parties once ratified.
Key Amendments and Trade-offs
The amendments aim to strengthen the Joint Committee's role in overseeing the agreement's application and resolving disputes, which could enhance regulatory cooperation but may also increase administrative burdens. The update balances trade liberalisation with regulatory alignment: while it reduces technical barriers to trade for EU and Swiss exporters, it requires Swiss conformity assessment bodies to comply with updated EU standards, potentially increasing compliance costs. The protocol also excludes certain sectors from the updated scope, maintaining national sovereignty over specific product categories.
Impact on Stakeholders
EU and Swiss manufacturers benefit from reduced duplication of testing and certification, lowering time-to-market and costs, especially for medical devices and gas appliances. However, they must adapt to updated regulatory references. National conformity assessment bodies face increased workload to align with new requirements but gain clearer procedures under the strengthened Joint Committee. EU regulatory bodies gain improved oversight through the Joint Committee, enhancing market surveillance but requiring additional resources. Consumers benefit from continued access to a wider range of products with assured safety standards, though no immediate price impact is expected.
Institutional Follow-up
The protocol will now be submitted to the European Parliament for consent, followed by ratification by both the EU and Switzerland. The strengthened Joint Committee is expected to begin work within six months of entry into force, focusing on dispute resolution and technical updates.
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