EU-Switzerland MRA Update 2026: What It Means for Medical Device Market Access

On March 2, 2026, the European Union and Switzerland signed a broad package of bilateral agreements that includes a long-awaited update to the Mutual Recognition Agreement (MRA) for medical devices. The original MRA's medical device chapter had been effectively non-functional since May 26, 2021, when the EU declined to update it to reflect the new Medical Device Regulation (EU) 2017/745. Switzerland was downgraded to a "third country" for medical device regulatory purposes, and both Swiss and EU manufacturers have been navigating a fragmented regulatory landscape ever since.

This guide explains what the new agreement changes, what stays the same for now, how swissdamed fits in, and what manufacturers on both sides should do while the ratification process unfolds.

Background: Why the MRA Lapsed

The Original MRA (2001–2021)

Switzerland and the EU had operated under an MRA for conformity assessment since 2001. Under this agreement, medical devices certified in either market could be sold in the other without duplicative regulatory procedures. Swiss Notified Bodies could issue CE certificates recognized by the EU, and vice versa. Manufacturers in both markets benefited from a single conformity assessment pathway.

The Breakdown (2021)

When the EU Medical Device Regulation (MDR) entered into application on May 26, 2021, the medical device chapter of the MRA needed to be updated to reference the new regulatory framework. However, broader EU-Swiss institutional negotiations had stalled — the Swiss government broke off talks on an overarching institutional agreement — and the EU linked the MRA update to progress on those wider bilateral issues.

As a result, the EU declared the MRA's medical device chapter no longer applicable. From May 26, 2021:

• Switzerland became a third country for medical device purposes.
• Swiss Notified Bodies' CE certificates were no longer recognized by the EU.
• Swiss manufacturers had to appoint an EU Authorized Representative and meet third-country requirements.
• EU manufacturers had to appoint a Swiss Authorized Representative (CH-REP) and comply with Swiss-specific registration requirements.
• Switzerland lost access to EUDAMED, the EU's medical device database.

The same disruption occurred for IVDs on May 26, 2022, when the IVDR entered into application.

Five Years of Fragmentation (2021–2026)

During the gap period, both markets adapted:

• Switzerland built swissdamed, its own medical device registration database, to replace lost EUDAMED access. The Actors module launched in August 2024, and the Device Registration module becomes mandatory on July 1, 2026.
• Swiss manufacturers navigated dual requirements: CE marking under MDR for the EU, plus separate Swiss registration and CH-REP appointment.
• EU manufacturers faced the reverse: maintaining CE marking for their home market while also appointing a CH-REP and registering devices with Swissmedic for Swiss market access.
• Market data underscored the interdependence: Switzerland exports approximately 46% of its medical devices to the EU and imports 54% from the EU, while the EU imports roughly 10% of its medical devices from Switzerland.

What the New Agreement Changes

The Agreement Package

The agreement signed March 2, 2026 is a broad package covering multiple sectors beyond medical devices. The medical device-specific elements are contained in the updated MRA and its Annex, which sets out sector-specific rules for conformity assessment.

Key Provisions for Medical Devices

1. Mutual recognition of conformity assessments is restored. Once the agreement enters into force, medical devices certified under the MDR (or IVDR) in either market will again be accepted in the other without duplicative procedures. This means:

• A CE certificate issued by an EU Notified Body will be recognized by Swissmedic.
• A CE certificate issued by a Swiss Notified Body will be recognized by EU competent authorities.
• Manufacturers will not need to undergo separate conformity assessments for each market.

2. Dynamic alignment through the equivalence method. A critical new institutional element: Swiss legislation will be required to achieve the same regulatory outcomes as EU legislation integrated into the agreement. This "equivalence method" ensures the MRA stays current as EU regulations evolve, preventing a repeat of the 2021 lapse where the MRA fell out of sync with the MDR.

3. Market surveillance cooperation resumes. Without a functioning MRA, Switzerland was excluded from EU market surveillance mechanisms. This made it harder for Swiss authorities to access information needed to respond quickly to unsafe products. The updated agreement restores cooperation, benefiting patient safety in both markets.

4. Updated MRA Annex references the MDR and IVDR. The previous Annex referenced the MDD and AIMDD directives. The updated Annex aligns with the current regulatory framework, including references to Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).

What Stays the Same (For Now)

The updated MRA has been signed but has not yet entered into force. Ratification must be completed by both sides:

• EU side: Requires consent of the European Parliament followed by formal approval by the Council.
• Swiss side: The package will be submitted to Parliament and is expected to be subject to a public vote (referendum), with timing and details still to be confirmed.

Until ratification is complete, the current framework remains unchanged. This means:

• Swiss manufacturers are still treated as third-country manufacturers for the EU market.
• EU manufacturers still need a CH-REP for the Swiss market.
• swissdamed registration requirements proceed as planned.
• EUDAMED access for Swiss entities remains unavailable.

Impact on EU Manufacturers

Current Requirements (Until MRA Enters into Force)

If you are an EU-based manufacturer placing devices on the Swiss market, you must currently:

1. Appoint a Swiss Authorized Representative (CH-REP). The CH-REP must be established in Switzerland (Liechtenstein-based companies are also acceptable due to the customs treaty). A formal Mandate between the manufacturer and CH-REP is required.
2. Register in swissdamed. The CH-REP registers the manufacturer in the swissdamed Actors module to obtain a Swiss Single Registration Number (CHRN).
3. Register devices in swissdamed starting July 1, 2026 (Device Registration module).
4. Maintain valid CE marking under the MDR. Switzerland fully recognizes CE certificates issued by EU Notified Bodies.
5. Comply with Swiss-specific labeling requirements, including the CH-REP name and address on the labeling or instructions for use.

After MRA Enters into Force

Once the updated MRA is ratified:

• The CH-REP requirement may be modified or phased out, depending on the final implementing provisions. EU manufacturers may regain the ability to market devices in Switzerland based on their EU conformity assessment alone.
• Market surveillance cooperation will resume, simplifying vigilance and FSCA coordination.
• swissdamed and EUDAMED interconnection may be addressed, though the specific technical arrangements are not yet defined.

Practical advice: Do not dismantle your current Swiss market access structure. Maintain your CH-REP, proceed with swissdamed registration, and plan for the MRA to take effect no earlier than late 2027 given the Swiss referendum process.

Impact on Swiss Manufacturers

Current Requirements

Swiss manufacturers placing devices on the EU market must currently:

1. Appoint an EU Authorized Representative (EC-REP) established in an EU member state.
2. Hold a valid CE certificate from an EU Notified Body (Swiss NB certificates are not recognized).
3. Register in EUDAMED (Actor module and Device UDI module, mandatory since May 28, 2026).
4. Meet all MDR requirements applicable to third-country manufacturers.

After MRA Enters into Force

• Swiss Notified Bodies' CE certificates will again be recognized by the EU.
• The EU Authorized Representative requirement may be simplified or eliminated for Swiss manufacturers.
• Access to EUDAMED may be restored for Swiss entities.
• Dual-market compliance costs should decrease significantly.

Swissdamed Timeline and Registration

Swissdamed is Switzerland's medical device information system, operated by Swissmedic. It was developed as a direct consequence of losing EUDAMED access.

Key Dates

Registration Requirements

• New devices placed on the Swiss market after July 1, 2026 must be registered in swissdamed before being placed on the market.
• Existing devices already on the market before July 1, 2026 must be registered by December 31, 2026.
• Registration is similar to the EUDAMED UDI/Device module and includes UDI data, device identification, and economic operator information.

Interaction with the MRA

The updated MRA does not eliminate swissdamed. Even after the MRA enters into force, Switzerland will continue to operate its own database for domestic regulatory purposes. However, the long-term goal is likely to be some form of interconnection between swissdamed and EUDAMED, reducing duplicate registration burden. The specific technical and legal arrangements for this have not yet been published.

Regulatory Equivalence: How It Works

The new dynamic alignment mechanism is the most significant institutional innovation in the updated MRA. Under the equivalence method:

• Swiss legislation must achieve the same regulatory outcomes as the EU legislation referenced in the agreement. Switzerland does not need to copy EU law verbatim, but its regulatory framework must produce equivalent results.
• Regular updates are built into the process. As the EU amends the MDR, IVDR, or related implementing acts, Switzerland will be expected to update its own legislation to maintain equivalence.
• This prevents a repeat of 2021. The previous MRA had no dynamic alignment mechanism, so when the MDR replaced the MDD, the MRA simply fell out of date.

For manufacturers, this means greater predictability. Regulatory requirements in Switzerland and the EU should remain aligned over time, reducing the risk of future divergence.

What Manufacturers Should Do Now

For EU Manufacturers Selling to Switzerland

1. Continue current Swiss market access procedures. Maintain your CH-REP, proceed with swissdamed Actor and Device Registration, and do not assume the MRA will enter into force quickly.
2. Register devices in swissdamed by the applicable deadline (July 1, 2026 for new devices, December 31, 2026 for all others).
3. Budget for dual compliance costs through at least 2027. Even after the MRA enters into force, there will be a transition period.
4. Monitor the Swiss referendum process for timing signals.

For Swiss Manufacturers Selling to the EU

1. Maintain your EU Authorized Representative and EUDAMED registrations. These are required regardless of the MRA status.
2. Ensure MDR conformity through an EU Notified Body. This will remain necessary until Swiss NB certificates are recognized again.
3. Prepare to benefit from the MRA. Once ratified, you may be able to reduce compliance costs by using a Swiss Notified Body for CE marking.
4. Engage with industry associations (Swiss Medtech, SVDI, MedTech Europe) for updates on implementing provisions.

For All Manufacturers

• Do not assume immediate change. The ratification process will take time — likely through late 2027 or beyond, given the Swiss referendum requirement.
• Keep dual-market documentation current. The gap period has forced most manufacturers to build parallel compliance structures. Maintain these until the MRA is operational.
• Watch for implementing guidance. Both Swissmedic and the European Commission will issue detailed guidance on how the updated MRA will be implemented in practice. This guidance is not yet available.

Key Takeaways

• The EU and Switzerland signed an updated MRA on March 2, 2026, restoring mutual recognition of medical device conformity assessments.
• The agreement includes a dynamic alignment mechanism (equivalence method) that should prevent future regulatory divergence.
• The MRA has not yet entered into force. Ratification by the European Parliament, Council, and a potential Swiss public referendum must be completed first.
• Until ratification, all current requirements remain: CH-REP for EU manufacturers, EU EC-REP for Swiss manufacturers, swissdamed registration, and EUDAMED registration.
• swissdamed Device Registration becomes mandatory July 1, 2026, with full compliance by December 31, 2026.
• Manufacturers should maintain their current dual-market structures and plan for the MRA to take effect no earlier than late 2027.

Sources

• European Commission, Press release: EU and Switzerland sign a broad package of agreements, March 2, 2026.
• Swiss Federal Council, Factsheet: Mutual Recognition Agreement (MRA), March 13, 2026.
• MedTech Europe, Swiss Medtech, and SVDI, Joint Statement: EU-Switzerland Agreement Package and Updated Mutual Recognition Agreement, March 12, 2026.
• MedTech Europe, EU-Switzerland Relations: Renewed Momentum on Mutual Recognition, March 5, 2026.
• Swissmedic, Swissdamed: Medical Device Information System, operational guidance, 2024–2026.
• Casus Consulting, Switzerland: Steps to Register & Sell Medical Devices (2026).
• Emergo by UL, New Guidance from Swiss Regulators on Medical Device Importation.
• Specculo, Swiss Medical Device Regulation, updated 2026.
• Efor Group, No Mutual Recognition Agreement Between the European Commission and Switzerland: Impacts for Manufacturers, 2021.
• ECA Academy, EU-Switzerland: MRA for Medical Devices No Longer Valid, June 2021.