Swissmedic Highlights Critical Deficiencies in Notified Body Opinions for Integral Combination Products
On 21 January 2026, Swissmedic published a focused review on Notified Body Opinions (NBOps) for integral combination products, underscoring substantial variability and content-related deficiencies in submitted opinions. This move signals more rigorous expectations for manufacturers bringing such products to the Swiss market—especially those affected by Article 117 of the EU MDR.
Background
Since Switzerland aligned its national requirements with the EU MDR (2017/745), any application for a medicinal product with an integral medical device component must demonstrate conformity with the General Safety and Performance Requirements (GSPRs) set out in Annex I of the MDR. In the absence of a CE certificate, a Notified Body Opinion is required for Class Is, Im, IIa, IIb, or III device components.
Swissmedic recently evaluated ten NBOps to assess whether they sufficiently support the authorisation process. The findings are a wake-up call for manufacturers.
Key Deficiencies Identified
Swissmedic found that most NBOps failed to provide complete or reliable evidence of GSPR conformity. Recurring issues included:
Unclear scope: It was often ambiguous which components were actually assessed.
Incorrect classification: Devices like spring-loaded autoinjectors were incorrectly considered non-active.
Missing or outdated standards: Superseded standards were frequently cited.
Insufficient data: Gaps were identified in areas like biocompatibility, usability, transport, and aging.
Inadequate GSPR coverage: Important requirements like GSPR 14.1 were missing or justified implausibly.
Importantly, Swissmedic confirmed that these deficiencies limit the usefulness of NBOps during regulatory review.
Updated Expectations for Manufacturers
Swissmedic has now issued clear instructions for what high-quality NBOps should include:
Explicit identification of which components are and aren't covered
Accurate classification and coding
A full, justified mapping of applicable and non-applicable GSPRs
Clearly presented verification and validation data, applicable to the final device version
A clear conformity statement from the Notified Body
Transparent traceability, including responsible individuals, versioning, and revision history
Swissmedic stresses that applicants themselves are responsible for critically reviewing the NBOp before submission. Failure to do so can lead to authorisation delays, while well-prepared NBOps may support timely approvals.
Why This Matters
For manufacturers of drug–device combination products, this development emphasizes the importance of strong collaboration with Notified Bodies and rigorous internal QA. Even for CE-marked devices, a superficial or incomplete NBOp could undermine your market access in Switzerland.
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