Technical Barriers to Trade (MRA)
Source: Dispatch on the Bilateral III package, Chapter 2.4 (pp. 472-491)
Dispatch PDF
¶ Summary
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.
¶ How the MRA Works
¶ Equivalence Method
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.
¶ 20 Product Sectors
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 |
¶ Medical Devices Blockage Since 2021
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.
¶ Consequences for Switzerland
- Swiss manufacturers need an EU authorised representative and EU certifications to sell on the EU market
- Double costs for conformity assessments
- Loss of equivalent regulatory space status
- Sector affected: approx. 1,400 companies with around 63,000 employees
- MedTech exports to the EU: approximately CHF 16.3 billion per year
¶ Solution in the Bilateral III Package
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.
¶ Institutional Anchoring
¶ New Institutional Protocol (IP-MRA)
The MRA receives its own institutional protocol comprising:
- Dynamic adoption of law: updating of product requirements in the MRA
- Surveillance: mutual market surveillance according to own requirements
- Dispute settlement: arbitration procedure with possible preliminary reference to the CJEU
- Decision Shaping: Swiss participation in EU committees and working groups
¶ Amendment Protocol (AP-MRA)
The amendment protocol updates the existing MRA and integrates the institutional provisions.
¶ Decision Shaping
Switzerland obtains the right to participate in the following bodies:
- MDCG (Medical Device Coordination Group) for medical devices
- Other sectoral committees and working groups of the European Commission
- Participation in the drafting of new requirements (without voting rights)
¶ Consultation
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.
¶ Economic Impact
¶ Costs
| 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 |
¶ GDP Effect if Abolished
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.
¶ Implementation
- No implementing legislation required -- the MRA is based on existing legal foundations
- Adjustments are made through existing ordinances
- Priority: swift updating of the Medical Devices chapter
¶ Key Points
| 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 |
¶ Sources
- Dispatch on the package for the stabilisation and further development of the bilateral path (Bilateral III), Chapter 2.4, pp. 472-491. Fedlex PDF
- Ecoplan Study: Economic effects of the bilateral agreements, 2024
- Regulation (EU) 2017/745 on medical devices (MDR)
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
- Agreement between the Swiss Confederation and the European Community on mutual recognition in relation to conformity assessment (SR 0.946.526.81)