Celebrating 10 years of innovative, global,
Regulatory solutions & services for Life Sciences industry

Regulation Changes

MedDO

Swissmedic revised Therapeutic Products Act (TPA) and Medical Device Ordinance (MedDO) for alignment with the European Medical Device Regulation (MDR), and the revised MedDO has come into force from May 26, 2021.

ClinDO

The Human Research Act (HRA) and Ordinance on Clinical Trials with Medical Devices (ClinO-MD) define the corresponding requirements for clinical trials of medical devices and for devices without a medical purpose.

What Does it Mean for Device Manufacturers in Switzerland?

Device manufacturers based in Switzerland must register the devices with MedDO and would not require appointing a Swiss AR/CH-REP as per Swiss medical device regulations.

What Does it Mean for Device Manufacturers Outside Switzerland?

Device manufacturers outside Switzerland must appoint a Swiss AR/CH-REP to register their devices in Switzerland as per the new medical device regulations.

Timeline of Change (visual timelines) with Class of Device

Timeline changes with Medical Device Classes

How to Register Under the New Regulations?

Swiss manufacturers, producing Class I devices according to the EU MDR 2017/745 and Directive 93/42/EEC and those that fall under the Class I, IIa, IIb, or III, must register their products via notification form and product list template.

Type of Devices

What Must be Done?

Responsible Entity

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

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 relabelled 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

Key Responsibilities of a Swiss AR/CH-REP

  • Must act on behalf of the foreign manufacturer and register the devices with MedDO
  • Verify the declaration of conformity and the technical documentation
  • Verify if appropriate conformity assessment procedures have been carried out by the manufacturer
  • Verify that the manufacturer has complied with the registration obligations
  • Keep a copy of the technical documentation, the declaration of conformity, and relevant certificates along with any amendments and supplements
  • In response to a request from Swissmedic, provide information and documentation necessary to demonstrate the conformity of a device
  • Forward Swissmedic request for samples or access to a device and ensure Swissmedic receives the samples or is given access to the device
  • Cooperate with Swissmedic on any preventive or corrective action or Field Safety Corrective Action (FSCA)
  • Immediately inform the manufacturer about any complaints and reports received from the market

Location of the Swiss AR

Any legal entity or natural person situated in Switzerland can act as a Swiss AR. The Swiss AR is responsible for product safety and will be held liable for defective products placed in Switzerland.

Qualifications and Requirements for a Swiss AR

Swiss AR must register with Swissmedic and obtain a Swiss Identification Number (CHRN). The Swiss AR must have a Person Responsible for Regulatory Compliance (PRRC) in the organization. The Swiss Agent must also have a written mandate with the manufacturer.

Liability

According to the Swiss Product Liability Act, a Swiss AR, along with the manufacturer, is jointly and legally liable for the defective products. A Swiss AR and the manufacturer are obliged to take liability insurance with sufficient coverage. The liability of a Swiss AR cannot be waived by contract.

Resources

  • Swissmedic’s New Medical Device Regulations

    Know More
  • Swixit and Its Impact on the MedTech Industry

    Know More
  • What is MedDO?

    Know More

Book a Meeting

Subscribe for our Newsletter

This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

Quick Inquiry
x