Geneva, 01 December 2025 — Swissmedic’s long-standing guidance document on packaging, ZL000_00_021e_WL, might look like a simple rulebook for drug labeling, but its latest version has thrown a new spotlight on medical device manufacturers. While the core of the document focuses on requirements for human medicinal products (HMPs), device makers involved in combination offerings are now facing critical new packaging mandates and compliance checks.
1. The Non-Negotiable Boundary: No Ce Mark On Medical device Packaging
The most direct instruction affecting device companies found in the latest guidance on drug packaging is a definitive exclusion:
The “CE” mark for medical devices may not appear on medicinal product packages.
This rule serves as a clear regulatory firewall, ensuring that a medicinal product’s compliance status (which is based on Swissmedic authorization) is never confused with a medical device’s compliance status (which is based on the EU’s CE mark and the Swiss Medical Devices Ordinance, or MedDO).
2. Mandatory Listing for Device “Kit” Components
Beyond what’s forbidden, Section 5.2.7 introduces a strict requirement for transparency on what is included in a drug pack:
Any medical devices included in the pack (applicators, alcohol wipes, etc.) must also be listed.
THE SWISSMEDIC PACKAGING RULES IMPACT ON MEDICAL DEVICE MANUFACTURERS
If you manufacture a product that is packaged alongside a drug you are impacted. The connection lies in the Swissmedic definition of a “Combination Pack”.
The guidance explicitly defines a Combination Pack as a package containing two or more products including a medicinal product with a medical device that are intended to be used together. These products are regulated as a single unit, and when the medicinal product component has the primary effect, the entire product falls under medicinal product legislation.
1. Mandatory Device Count on Packaging
A key change flagged in the document’s update is the requirement for “Addition to section 6.7: Information on number of medical devices included in the pack”.
This means that if a medical device (like an injector, a measuring cup, or a specific applicator) is co-packaged with the medicinal product, the drug’s packaging text now must clearly state the number of devices included. This is a crucial labeling task that requires close coordination between the medical device and pharmaceutical divisions of a company.
2. Devices Must Meet MDR Safety Standards
For non-separable combinations (integral, like a pre-filled syringe) and co-packaged combinations (drug and device in the same box), the medical device component, while authorized as part of a medicinal product, must still meet the fundamental safety and performance requirements laid out in Annex I of the EU Medical Device Regulation (EU-MDR 2017/745).
This means medical device manufacturers contributing to combination products must ensure their quality and technical documentation aligns with the stringent EU-MDR standards, even though the final authorization process runs through the drug regulatory stream (HMP legislation).
COMBINATION PRODUCT LABELING : COMPLIANCE CHECKLIST FOR DEVICE MAKERS
For manufacturers whose devices are used in drug combination packs, this Swissmedic guidance is a clear signal to:
- Review Packaging Texts: Immediately check your co-packaged product labels to ensure the number of devices included is clearly stated on the medicinal product’s secondary packaging, in line with the ZL000_00_021e_WL requirements.
- Confirm MDR Compliance: Verify that all associated device components meet the EU-MDR’s basic safety and performance requirements, as this is a fundamental prerequisite for their inclusion in a Swiss-authorized combination product.
- Strengthen Internal Alignment: Ensure robust communication and documentation hand-offs exist between the medical device manufacturing unit and the pharmaceutical marketing authorization holder (MAH) unit to maintain seamless regulatory compliance for the entire combination product.