Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Medical device conformity assessment and placing on the market (Art. 45-47 HMG; MepV)

Switzerland · Swissmedic · Medical devices

Device: conformity assessment by a certification bodyHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

Not published

Steps

9 requirements

What is the Medical device conformity assessment and placing on the market in Switzerland?

For medical devices, including software, the manufacturer classifies the device under the EU MDR rules, runs the conformity assessment set out in the EU MDR, using a designated body where required, and declares conformity before placing it on the market. Certificates from EU or EEA notified bodies are accepted. A manufacturer outside Switzerland needs a Swiss authorized representative. Placing a medical device or accessory on the Swiss market.

What are the steps of the Medical device conformity assessment and placing on the market?

1. Classify the device; 2. Conformity assessment; 3. Declaration of conformity; 4. Register operators and the device; 5. Place on the market and monitor.

Does the Medical device conformity assessment and placing on the market rely on other regulators?

Yes. It relies on approvals from European Union (recognition).

Outcome: The device can be placed on the market. Certificates are valid for at most five years and can be renewed.

Legal basis: Therapeutic Products Act (HMG) Articles 45 to 47; Medical Devices Ordinance (MepV), which refers to Regulation (EU) 2017/745 (EU MDR)

Steps

In order, with the official target for each step

1. Classify the deviceClasses I, IIa, IIb and III, based on intended purpose and risk, using the EU MDR classification rules.
2. Conformity assessmentThe procedure follows the EU MDR annexes. Where required, a designated conformity assessment body is involved and issues a certificate.
3. Declaration of conformityThe manufacturer declares conformity before placing the device on the market.
4. Register operators and the deviceManufacturers or their Swiss representatives and importers register with the agency. Device identification data are also registered.
5. Place on the market and monitorPost-market surveillance, reports and vigilance.

Requirements

What the applicant must provide or meet

Eligibility

Classification under EU MDR Annex VIIIDevices fall into classes I, IIa, IIb and III by intended purpose and risk. Annex VIII of the EU MDR decides the class.

Clinical evaluation

Clinical evaluationProof of the general safety and performance requirements includes a clinical evaluation under Article 61 of the EU MDR.

Local presence

Swiss authorized representative (CH-REP)A manufacturer without a seat in Switzerland can place devices on the market only through a written mandate with an authorized representative based in Switzerland. The representative is responsible for reporting serious incidents.

Language

Product information in three official languagesLabels and instructions must be in German, French and Italian. Fewer languages or English are allowed in some cases, for example for products supplied only to professionals.

Reference approval

EU and EEA certificates accepted(optional)Certificates from bodies designated under EU law in an EU or EEA state are treated like Swiss certificates if the procedures meet Swiss requirements and the body is equally qualified.

Other

Registration with the agencyManufacturers or their representatives and importers register before first placing a device on the market and get a Swiss registration number. Device identification data are also registered with the agency.

After approval

Post-market surveillance report (class I)Makers of class I devices write a post-market surveillance report and update it when needed.
Periodic safety report (classes IIa, IIb, III)Class IIa reports are updated at least every two years. Class IIb and III reports are updated at least once a year.
Report serious incidents in SwitzerlandSerious incidents in Switzerland and field safety corrective actions taken in Switzerland are reported to the agency.

Medical device conformity assessment and placing on the market (Art. 45-47 HMG; MepV)

What is the Medical device conformity assessment and placing on the market in Switzerland?

What are the steps of the Medical device conformity assessment and placing on the market?

Does the Medical device conformity assessment and placing on the market rely on other regulators?

How the pathway works

Timeline with clock stops

Steps

Requirements

Eligibility

Clinical evaluation

Local presence

Language

Reference approval

Other

After approval

Official time targets

Fees

Reliance on other regulators

Rule changes