Source: Dispatch on the Bilateral III package, Chapter 2.4 (pp. 472-491)
Dispatch PDF
The Mutual Recognition Agreement on conformity assessments (MRA) is one of the economically most important agreements of the Bilateral I package. It eliminates technical barriers to trade through mutual recognition of assessments and certifications. The MRA covers 20 product sectors -- from machinery to medical devices to construction products -- and comprises approximately two thirds of the value of all industrial products traded between Switzerland and Europe, with an export volume of CHF 105 billion (as of 2024).
Since 2021, the MRA has been blocked in the medical devices sector: the EU has not updated the relevant chapter, causing Swiss manufacturers considerable additional costs. The Bilateral III package aims to resolve this blockage and institutionally anchor the MRA.
The MRA is based on the equivalence method: Switzerland does not have to adopt EU law word for word but must achieve an equivalent result. Swiss conformity assessment bodies (e.g. METAS, SNV, Electrosuisse) can assess and certify products according to EU requirements -- and vice versa. This eliminates duplicate assessments and the associated costs.
The MRA covers the following sectors (selection):
| Sector | Examples |
|---|---|
| Machinery | Machine tools, industrial robots |
| Medical devices | Implants, diagnostics, surgical instruments |
| Construction products | Cement, windows, insulation materials |
| Electrical engineering | Low-voltage equipment, EMC |
| Pressure equipment | Boilers, piping |
| Lifts | Passenger and freight lifts |
| Measuring instruments | Scales, gas analysers |
| Personal protective equipment | Helmets, protective gloves |
The EU adopted the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) in 2017. The MDR has been in force since May 2021 -- however, the EU has not updated the corresponding MRA chapter, due to the lack of an institutional framework agreement.
Updating the Medical Devices chapter of the MRA has the highest priority. Switzerland aims to update the chapter before the entry into force of the entire Bilateral III package.
The MRA receives its own institutional protocol comprising:
The amendment protocol updates the existing MRA and integrates the institutional provisions.
Switzerland obtains the right to participate in the following bodies:
The consultation on the MRA yielded 68 submissions:
| Position | Number | Key actors |
|---|---|---|
| In favour | 56 | Cantons, economiesuisse, Swissmem, Swiss Medtech, FDP, The Centre, SP, GLP |
| Against | 3 | SVP, isolated organisations |
| No clear position | 9 | Various |
The large majority welcomes the institutional anchoring and the swift resolution of the medical devices blockage.
| Item | Amount/Scope |
|---|---|
| Electronic monitoring system | CHF 250,000 (one-off) |
| Additional SECO staff | 2 FTE (full-time equivalents) |
| Additional Brussels Mission staff | 1 FTE |
The Ecoplan study quantifies the GDP effect of an abolition of the MRA at -4.9% by 2045. The MRA is thus the economically most important bilateral agreement.
| Topic | Detail |
|---|---|
| Agreement | MRA -- Mutual Recognition of Conformity Assessments |
| In force since | 1999 (Bilateral I) |
| Product sectors | 20 sectors |
| Export volume | CHF 105 billion (2024) |
| Method | Equivalence method (equivalent result, not identical rules) |
| Medical devices blockage | Since May 2021, resolution is top priority |
| Companies affected | approx. 1,400 with 63,000 employees |
| Institutional protocol | IP-MRA + AP-MRA |
| Decision Shaping | Participation in MDCG and other committees |
| GDP effect if abolished | -4.9% by 2045 |
| Consultation | 56 in favour, 3 against (of 68) |
| Implementation costs | CHF 250,000 + 3 FTE |
| Legislation | No implementing legislation required |