Medical Devices Regulatory Services
in the Switzerland

Overview

Switzerland medical device companies have generated sales of CHF 17.9 billion in 2019, which is 2.6% of Switzerland’s total GDP. In 2019, Switzerland has exported medical devices worth 12 billion and imports worth CHF 5.9 billion. With > 1400 Medtech companies, the medical devices sector accounts for 3% of Switzerland’s GDP and provides employment for > 63, 000 workforce.

Regulatory Authority: Swiss Agency for Therapeutic Product (Swissmedic)

Regulation:  Medical Device Ordinance (MedDO)

Regulatory Pathway: Notification

Authorized Representative (AR):  Swiss Authorized Representative

QMS Requirement: ISO 13485:2016

Assessment of Technical Data: Designated Body

Validity of License: Five (05) Years

Labeling Requirements:  Regulation (EC) No 1272/2008; Labeling Must Be Provided in German, French and Italian

Submission Format: Online

Language: German, French and Italian

Regulation of Medical Devices in Switzerland

In 2017, Federal Counselor has issued Medical Device Ordinance (MedDO) and Medical Device Clinical Trials Ordinances (ClinO-MD), which are in effect from May 26, 2021. The In-Vitro Diagnostic Ordinance (IvDO) is expected to be released in second half of 2021.

 Medical Device Classification

 The medical device classification in Switzerland is similar to the EU MDR’s classification system. The devices are classified into four (04) classes – Class I, IIa, IIb and III. The Class I devices are of lower risk and the risk increases towards Class III devices.

Device Class

Risk

Class I

Lowest Risk

Class IIa

Moderate/Measured Potential Risk

Class IIb

High/High Potential Risk

Class III

Highest Risk

Swiss Authorized Representative (AR)

 The foreign medical devices or IVDs must appoint a Swiss Authorized Representative before placing the products in Switzerland. The manufacturer and the representative must have an agreement in place. The Swiss Authorized Representative for a medical device will act on behalf of the Swiss manufacturer and as the key contact person for Swissmedic and associated Authorities. The Swiss Representative shall be a natural person or can be a legal entity. The Swiss Authorized Representative (AR) is responsible for product safety and is liable for product defects. The Swiss AR must appoint a Person Responsible for Regulatory Compliance (PRRC).

 Medical Device Registration in Switzerland

 The regulations require the manufacturers to notify the medical devices and IVDs to Swissmedic before they are placed on the Switzerland market. Additionally, the economic operators need to be registered with Swissmedic.

Swissmedic Notification Requirements for Medical Devices

Type of Device

What has to be done?

Responsible Entity

Class I devices according to the EU MDR 2017/745 and Directive 93/42/EEC are those that fall under the Classes I, IIa, Iib or III

Via notification form and product list template

Swiss manufacturers

Custom made devices

Via notification form

Swiss manufacturers, Ars, importers / distributors

Systems and procedure packs

Via notification form

Swiss based assemblers

MD – Devitalized human tissue

Via notification form

AR, legal manufacturer

Device products

Via notification form

Legal manufacturers, Ars, importers / distributors

Repacked or relabeled medical devices

Via notification form and product list template

Swiss importers / distributors

Medical devices manufactured and used in health institutions

Via notification form

Swiss health institutions

Swissmedic Notification Requirements for IVDs

Type of Device

What has to be done?

Responsible Entity

IVD

Via notification form

Authorized representatives or Swiss manufacturers

Self-testing IVDs, other IVDs

Via notification form

Individual

IVD manufactured in-house by the producing or partner company

Via notification form

Swiss manufacturers

Expertise

Freyr Expertise

  • Swiss Authorized Representative Services
  • Medical Device Ordinance (MedDO) Compliance
  • IvDO Compliance
  • Swissmedic Device and IVD Notifications
  • Swissmedic Registrations
  • Device Information and Label Translations
  • Gap Analysis – MedDO and IvDO