Switzerland Medical Device Regulation Changes

Given below are some important Switzerland medical device regulations, which manufacturers must become familiar with:

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.

IVDO

The Federal Council on May 4, 2022, adopted a new regulation “In Vitro Diagnostic Medical Devices Ordinance (IvDO)” which came into May 26, 2022, to ensure patient safety via a stringent regulatory framework for conformity assessments and post-market surveillance of IVDs.

What Does it Mean for Device Manufacturers in Switzerland?

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

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.

In the case of IVDs, manufacturers (domiciled) are required to register under Swissmedic for classes A (sterile), B, C, and D by notifying them individually with certification documents (CE certification) along with submission of form1 and form2.

Class A (non-sterile) are required to register under Swissmedic by notification either individually or as device groups along with the submission of form.

Key Responsibilities of a Swiss AR/CH-REP

• Must act on behalf of the foreign manufacturer and register the devices in accordance with MedDO/IVDO
• 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.