Swissmedic Updates Formal Requirements Guidance – Version 19.0 Applicable from February 2026
Swissmedic has published Version 19.0 of its Guidance Document “Formal requirements”, which will apply to all submissions from 1 February 2026. The document consolidates and clarifies the formal and administrative requirements for applications submitted to the Swiss authority, replacing previous versions in case of divergence.
Although the guidance is primarily addressed to administrative bodies, it is highly relevant for manufacturers and marketing authorisation holders, as it defines how dossiers must be structured and submitted to ensure efficient processing by Swissmedic.
Scope and applicability
The guidance applies to all submissions to Swissmedic and covers formal aspects such as submission formats, signatures, documentation structure, timelines, and administrative forms. It does not apply to medical devices as standalone products, clinical trials, inspections, certificates, or legal cases.
However, manufacturers should note that the document does apply to medicinal products that include a medical device component, i.e. combination products.
Key points manufacturers should be aware of
1. Clear responsibility of the applicant
Swissmedic reiterates that, as a general principle, all documentation must be submitted by the applicant, who bears full legal responsibility as the (future) marketing authorisation holder. Submissions by third parties are accepted only in limited cases, such as DMF/ASMF dossiers.
2. Strict formal compliance and timelines
In cases of formal deficiencies, applicants have a maximum of 60 days to rectify shortcomings, with no possibility of extension. Failure to comply may result in negative decisions or delays.
3. Increased emphasis on submission quality and structure
The guidance reinforces requirements for:
Machine-readable (OCR) PDF documents
Clear document structure and bookmarking for large files
Consistent use of official CTD/NTA numbering
Proper use of Swissmedic cover sheets and dividers for paper submissions
Poor formatting or incorrect structuring may lead to formal objections, even if the scientific content is adequate.
Specific implications for manufacturers of combination products
One of the most relevant sections for Smart MDR readers is Section 2.5.15, which details the requirements for medicinal products with a medical device component.
Swissmedic clearly distinguishes between:
Non-separable (integral or co-packaged) combinations, and
Separable (referenced) combinations
Depending on the type of combination and the risk class of the medical device, manufacturers may need to submit:
A CE Declaration of Conformity
A Notified Body certificate (for higher-risk classes)
Or, where the device is not CE-marked, evidence of compliance with Annex I of the EU MDR, including a Notified Body Opinion in accordance with Article 117 MDR.
Swissmedic also highlights that all required documentation for the medical device component should be available at the time of submission, even if a later submission date is exceptionally agreed due to notified body capacity constraints.
Why this matters for manufacturers
While Version 19.0 does not introduce a new regulatory framework, it tightens expectations around consistency, completeness, and formal correctness. For manufacturers, this means:
Greater need for early planning, particularly for combination products
Increased importance of alignment between medicinal product and medical device documentation
Reduced tolerance for administrative errors that can delay approvals or variations
Next steps
Manufacturers planning submissions to Swissmedic in 2026 or later should review their internal submission processes against the updated guidance and ensure that external partners (including notified bodies and DMF holders) are aligned with the new expectations.
The full guidance document “Formal requirements”, Version 19.0, is available on the Swissmedic website and applies from 1 February 2026.
