MRA update: the package agreement of 2 March 2026 and the future of the CH-REP

This article is the 49th instalment of Volume 5, Post-market Compliance and Regulatory Developments, of the 50-part series on medical device registration in Switzerland. Together with the remaining nine articles of this volume it forms the complete deliverable on this topic. The publication timestamp, article number, title and unique URL are set out in the table below.

1. Key takeaways

On 2 March 2026, the European Union and Switzerland signed a package agreement that includes a protocol amending the Mutual Recognition Agreement, the MRA, and its annexes. That protocol can only enter into force once both sides have ratified it. Until then, the status quo of Chapter IV of the MRA is unchanged, and foreign manufacturers must continue to designate a CH-REP. Statements that the protocol will enter into force no earlier than 2028 are industry forecasts; they must be labelled as a practical estimate and must not be used as a planning basis. The gap between signing and entry into force is where the compliance risk lives. Companies that treat the signature as the finish line start dismantling their Swiss-specific arrangements too early, while the law still requires them in full.

2. Legal basis

3. Expert insights

1. Between signature and entry into force lie two ratification procedures, and they cannot be collapsed into one. The package agreement was signed on 2 March 2026, but the protocol requires ratification by both sides before it takes effect: on the EU side, the consent of the European Parliament and adoption by the Council; on the Swiss side, the parliamentary procedure and an expected referendum. The judgement is that each procedure carries its own uncertainty, and a delay on either side postpones entry into force. The counterpoint is the behavioural one: markets tend to read the signature as the imminent beginning of application, and to relax their preparation on the CH-REP and registration duties ahead of time. This is currently the single most common source of misjudgement in Swiss market planning.

2. The dormant state of MRA Chapter IV has persisted since May 2021, and the signature does not change it. Chapter IV has not been updated by the EU since May 2021, which is why Switzerland occupies a third-country position in the device field. Signing the protocol does not automatically restore mutual recognition; until entry into force, the status quo applies unchanged. The trade-off for companies is between attentiveness and discipline: track the progress, yes, but never build transition plans on an assumption. The correct posture is to maintain the current compliance configuration in full, while reserving room to adjust once institutional changes actually materialise.

3. The fate of the CH-REP and the status of the MRA are not the same question. MedDO Art. 51 para. 1 provides that a foreign manufacturer must designate an authorised representative established in Switzerland by written mandate, and without such designation the device may not be placed on the market. This is an unconditional requirement at the level of the ordinance, with no textual linkage to whether the MRA is updated. The judgement is that even if the protocol enters into force and mutual recognition returns, the CH-REP duty would only change through an amendment of the ordinance, not automatically with the MRA. As a practical estimate, no company should delay or scale down its CH-REP arrangements on the argument that the MRA is about to be updated. Swissmedic has also issued its implementation note on the federal contribution and fee ordinance amendments (19 June 2026), so institutional costs continue to accrue under the current rules.

4. Practical recommendations

1. Maintain the existing CH-REP, CHRN and swissdamed registration arrangements unchanged; do not adjust or reduce the investment because the package agreement has been signed.
2. In the internal compliance calendar, record ratification and entry into force of the protocol as an observation item, not a confirmed milestone; the effective date is governed by official publications on both sides.
3. Label every forecast about timing, including statements that entry into force will be no earlier than 2028, as a practical estimate, and keep them out of external commitments and contract clauses.
4. Include a review clause for institutional change in the CH-REP mandate contract, agreeing that the allocation of duties is re-evaluated after a substantive change in MRA status.
5. Track the Swiss-side implementing changes in parallel: the version of the fee ordinance in force from 1 July 2026 introduced the device registration fee, so institutional alignment does not necessarily bring costs down.

5. Verification checklist

• □ The signature date of the package agreement is recorded as 2 March 2026, with confirmation that the protocol requires ratification by both sides.
• □ It is confirmed that MRA Chapter IV has not been updated since May 2021 and that the status quo applies until entry into force.
• □ Internal documents label the forecast of entry into force no earlier than 2028 as a practical estimate and industry forecast.
• □ The CH-REP mandate arrangements remain effective in the current state and have not been scaled down.
• □ The CH-REP mandate contract contains a review clause for institutional change.
• □ A responsible owner for MRA progress tracking and periodic review has been designated.

Legal information verified as of 29 October 2026.

GRZAN supports manufacturers entering or operating in the Swiss market with post-market compliance services, covering vigilance reporting, field safety corrective actions and Swissmedic inspection readiness. Our team maintains full CH-REP and registration arrangements through MRA transitions, tracks ratification milestones and keeps Swiss compliance investment aligned with the law as it stands. For support with your Swiss post-market obligations, contact info@grzanglobal.com.