Traceability of Medical Devices: What is UDI and how it is used in Switzerland

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Medical device traceability is now one of the central elements of regulatory compliance in Switzerland. With the entry into force of the new Swiss regulations aligned with the European framework, the Unique Device Identification (UDI) system has become a mandatory tool to ensure unique identification, patient safety and post-marketing surveillance.

For manufacturing companies, manufacturers and importers active in the Swiss market, understanding and properly implementingUDI medical devices is not only a regulatory requirement, but a strategic factor in risk control and quality system robustness. In this context, the support of consultants specializing in regulatory and quality for the life sciences sector can make all the difference in the proper setup of the UDI project.

What is Unique Device Identification (UDI)

The UDI is a unique identification system that allows each medical device to be distinguished by a standardized code that can be read in either human or machine readable format (barcode or DataMatrix).

The UDI system is regulated in Switzerland by the Swiss Agency for Therapeutic Products (Swissmedic) under the Medical Devices Ordinance (MDA), which implements the principles of Regulation (EU) 2017/745 (MDR).

Official normative references:

Structure of the UDI code

UDI consists of two main elements:

UDI-DI (Device Identifier)

Static part identifying:

  • manufacturer
  • device model
  • specific version or configuration

The UDI-DI is also the key reference for registration in regulatory databases.

UDI-PI (Production Identifier)

Dynamic part that may include:

  • batch number
  • serial number
  • date of production
  • expiration date

The combination of UDI-DI and UDI-PI enables complete traceability throughout the supply chain.

UDI and traceability medical devices CH

In the Swiss context, medical device CH traceability becomes particularly relevant following full technical alignment with the European MDR and the need to ensure transparency and control even in the absence of the updated Mutual Recognition Agreement (MRA).

UDI enables:

  • Improving patient safety
  • Facilitating safety recalls and corrective actions (FSCA)
  • Strengthening post-market surveillance (PMS)
  • Support regulatory audits and inspections

UDI data must be registered in the European EUDAMED database:
https://ec.europa.eu/tools/eudamed

Although Switzerland does not operate an equivalent autonomous database, Swissmedic uses EUDAMED as a reference for regulatory cooperation.

Obligations for producers, manufacturers and importers

According to ODmed, UDI is mandatory for most medical devices placed on the Swiss market.

Manufacturer

  • Assigns and maintains UDI
  • Ensures consistency between label, technical documentation and registration in EUDAMED
  • Integrates UDI into the quality management system (QMS)

Importer

  • Verify that the device reports the compliant UDI
  • Check the manufacturer’s correct registration
  • Keeps documentation for traceability

Distributor

  • Verify the presence of UDI
  • Collaborates in the management of any recalls

For life sciences companies, this implies a structured integration of UDI into quality assurance and regulatory affairs processes.

UDI and traceability: is your system really compliant?

Many critical issues related to UDI do not result from code assignment, but from management that is not integrated into the quality system, incomplete procedures, or misalignment between labeling, technical documentation, and EUDAMED.

A structured assessment allows you to identify any gaps with respect to ODmed and MDR, verify the correct assignment of UDI-DI, and ensure consistency between Regulatory, Quality, and Supply Chain.

Pharmanomos Sagl supports producers, manufacturers and importers in the life sciences sector in the compliant implementation of UDI medical devices in Switzerland, integrating regulatory and quality system requirements.

Request a preliminary audit of your UDI system.

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How to implement UDI effectively

The implementation of UDI in medical devices is not limited to the assignment of an identification code, but requires a structured organizational approach involving several business areas.

To ensure effective management that complies with regulatory requirements, there is a need to ensure consistency between device labeling, technical documentation, records in regulatory databases, and corporate information systems.

This process typically involves several business functions, including Regulatory Affairs, Quality Assurance, IT and Supply Chain, and must be integrated into the organization’s quality management system.

Proper implementation of UDI allows not only to meet regulatory obligations, but also to strengthen traceability systems, support post-market surveillance activities, and improve the management of recalls or safety corrective actions.

In this context, a structured view of traceability is a key element in ensuring regulatory compliance and transparency throughout the medical device lifecycle.

Frequent critical issues

The main nonconformities found in audits include:

  • UDI-DI assigned inconsistently with product variants
  • Failure to re-evaluate UDI when significant changes are made
  • Misalignment between technical documentation and database
  • Lack of integration into the quality system

A structured approach, guided by experienced regulatory and quality professionals for the pharmaceutical and medical device industries, enables the prevention of such critical issues and the transformation of regulatory obligation into a competitive advantage.

Conclusions

Themedical device UDI is now a pillar of regulatory compliance in Switzerland. It is not just a labeling requirement, but an integrated identification and traceability system that impacts quality, supply chain, and vigilance.

For manufacturers, manufacturers and importers active in the Swiss market, properly implementing medical devices CH traceability means ensuring safety, regulatory soundness and audit readiness.

Medical devices CH traceability: are you ready for an inspection?

UDI is not only a labeling requirement, but a central element of traceability and post-market surveillance. Errors in UDI management can surface during Swissmedic audits or inspections, with significant regulatory and reputational impacts.

A proactive approach makes it possible to strengthen compliance, reduce the risk of noncompliance, and structure a robust and sustainable quality system over time.

Pharmanomos Sagl – Experts in Regulatory and Quality for the Life Sciences Industry – offers specialized consulting for the pharmaceutical and medical device industry, supporting companies in complying with UDI and traceability requirements in Switzerland.

Contact us for a customized regulatory assessment.

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