Switzerland Medical Device Registration

Navigating Medical Device Registration & Post-Market Surveillance in Switzerland

Overview on Medical Device Registration

Medical devices in Switzerland do not undergo an official authorization process, unlike medicinal products. Instead, Switzerland adheres to the European Union (EU) system of compliance assessment and certification for these devices, as outlined in bilateral agreements. Private entities evaluate compliance with internationally recognized norms.

Various risk categories are assigned to medical devices, each requiring different assessment procedures. The outcome of a compliance assessment is the issuance of the CE label, allowing the placement of medical devices on the market within the EU and, through unilateral recognition of the CE label, in Switzerland as well.

Swissmedic primarily focuses on effective market surveillance in the field of medical devices. Additionally, Swissmedic is responsible for designating and monitoring conformity assessment bodies and establishing requirements in the form of technical standards.

Regulatory Authority

Swissmedic

Swissmedic is the Swiss authority responsible for authorizing and supervising therapeutic products, based on the Law on Therapeutic Products. As a Federal public law institution, it is autonomous and has its own budget. It is primarily funded by fees and payments from the Confederation.

Swissmedic is attached to the Federal Department of Home Affairs, with the Agency Council as its strategic decision-making entity. The Council represents Swissmedic’s interests and approves its budget, annual accounts, and reports. Swissmedic manages its activities through strategic goals, based on the revised Therapeutic Products Act.

Its core competencies include authorisation of medicinal products, manufacturing and wholesale licenses, inspections, market monitoring, prosecution, clinical trials, establishing standards, information, and national and international cooperation.

Link for Regulatory Authority

Homepage (swissmedic.ch)

Local Regulation 

SwissMedDO (based on Medical Device Regulation MDR (EU) 2017/745)

Overview of Regulations

The Federal Council adopted the new Ordinance on In vitro Diagnostic Medical Devices (IvDO) and amendment to the Ordinance on Clinical Trials with Medical Devices (CTO-MedD) on 4 May 2022. The new regulations aim to improve patient safety by requiring stricter requirements for conformity assessment and post-market surveillance. They will come into force on 26 May 2022, concurrently with the application of EU Regulation 2017/746 on IVDR.

Since 2001, Switzerland has been equivalent to the EU in medical device regulation. However, due to the COVID-19 pandemic, limited capacities of notified bodies, and the complexity of the Regulation, proper implementation could not be guaranteed. 

Therefore, the EU adopted “Regulation (EU) 2022/112 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices” on 25 January 2022.

The Swiss Ordinance on In Vitro Diagnostic Medical Devices (IvDO) also considers these new transitional periods in the EU, ensuring Switzerland continues to be supplied with safe in vitro diagnostic medical devices and limiting the negative consequences of failure to update the Mutual Recognition Agreement (MRA) on surveillance. 

The provisions allow for the unilateral recognition of EU certificates of conformity, reducing supply problems associated with in vitro diagnostic medical devices in Switzerland. Supplementary requirements such as registration of economic operators, reporting of serious incidents to Swissmedic, and the establishment of a Swiss authorised representative (CH-REP) for foreign manufacturers will help maintain Swissmedic’s market surveillance system despite its exclusion from the network of EU authorities.

Classification of Medical Devices

Class I, IIa, IIb and III

Listing or Registration Requirements

• Register devices and economic operators in EUDAMED
• Report incidents
• Run post-market-surveillance and
• Carry out conformity assessments for class I and higher devices with a notified body.
• EU certification is required for most, but not all, medical devices. Whether an EU certificate is required depends on the risk class of the product.
• GMDN of products.
• Notification of non-EU manufacturer is done by an appointed AR. Notification of medical devices are done through Swissdamed ( Swissdamed will be fully operational by 2024).

Documents Required for Switzerland Medical Device Registration 

• Name and code of the medical device, its classification, its nomenclature, name of the Manufacturer or its authorized representative or importer
• CE Conformity Certificates
• EC Declaration of Conformity (must be in German, French Italian or English)
• Packaging box (Box, Labelling and instructions for use (must be in German, French and Italian))
• Technical file

Registration Timeline

Within 30 days after notification

Registration Fee

• Application review fees: 200 CHF
• Manufacturer registration: 200 CHF

License Validity

5 Years

Special Labelling Requirements

Labelling, instructions for use and other information available in French, German, Italian

International Medical Device Regulators Forum (IMDRF)

The International Medical Device Regulators Forum (IMDRF) is a coalition of global medical device regulators working together to expedite the harmonization and convergence of international medical device regulations.

International harmonization serves as a crucial foundation for streamlining regulatory efforts for both regulatory authorities and companies, facilitating regulatory cooperation and leveraging synergies.

Responding to Swissmedic’s request, the IMDRF granted the Swiss Agency for Therapeutic Products the status of Official Observer at Management Committee Meetings. This newly conferred status represents a significant interim achievement towards Swissmedic’s strategic goal of becoming a member of the Management Committee.

Since 2021, experts from Swissmedic have actively participated in various working groups within the IMDRF.

Reporting Incidents & FSCAs (Vigilance)

• Incidents

An incident, as defined by MedDO/ IvDO, is an occurrence linked to a device. Incidents categorized as serious and happening in Switzerland or Liechtenstein are required to be reported to Swissmedic.

Swissmedic systematically gathers and assesses these incident reports.

The purpose of this reporting system is to safeguard the health of patients and users, specifically aiming to prevent the recurrence of serious incidents stemming from issues related to the design, manufacturing, or usage of devices according to MedDO/ IvDO.

• Field Safety Corrective Actions (FSCAs)

In cases where problems arise with devices according to MedDO/ IvDO, the manufacturer or the entity assembling the systems or procedure packs (System and Procedure Pack Producer – SPPP) may need to initiate a Field Safety Corrective Action (FSCA). Swissmedic monitors all FSCAs related to devices according to MedDO/ IvDO that are distributed in Switzerland or Liechtenstein.

Additional Comments 

Swiss manufacturers and authorized representatives shall register all medical devices in the Medical Device Database before they are placed on the market. If the manufacturer is not based in Switzerland, their products may only be placed on the market if they have authorized a person based in Switzerland. The mandate must be agreed in writing.

Mandatory notification for devitalized human tissue: Anyone wishing to import classical and active implantable medical devices with components from devitalized human tissue into Switzerland must notify Swissmedic.

Who should make this Communication?

• Manufacturer
• Authorized Representative

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the Process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk