As the number of device-led delivery formats increases, the NBOp process is triggered more often. That makes consistency, evidence ownership, and supplier alignment much more important than they were when combination products were lower-volume and treated as exceptions. As well as creating a backlog in notified body reviews.
The collision point: where regulation meets market demand
These forces amplify each other.
Article 117 introduces a device evidence checkpoint that many pharma organizations did not historically operate at scale.
At the same time, the market is shifting more products into combination formats such as prefilled syringes and autoinjectors, which increases the number of programs and lifecycle changes that need device-grade evidence.
As volumes rise, so does the frequency of NBOp submissions, variations, supplier engagement and technical evidence preparation. That increases pressure on the same internal experts and on a process that is still maturing in terms of predictability and consistency.
How Ensera helps: device constituent readiness, built on 30 years in sterile devices
Article 117 has changed what “ready for submission” looks like for combination products. It is no longer enough for the device constituent evidence to exist somewhere within a program. It needs to be structured, traceable, and review-ready, with clear ownership across suppliers and internal teams.
With 30 years’ experience in sterile single-use medical devices and pharma expertise, Ensera is well placed to help combination product programs build device constituent readiness for EU submission pathways.
That support covers the full device evidence package required to demonstrate conformity with relevant GSPRs.
In practical terms, our support focuses on four outcomes:
1) Earlier clarity on what evidence is needed, and who owns it
You move faster when you define early which requirements apply, what “good evidence of conformity” looks like, and where it will sit in the dossier. EFPIA’s findings show that poor structure and incomplete submissions are a common source of delay.
2) A submission-ready device constituent package, not fragmented documents
For combination products, evidence is often distributed across device suppliers, contract partners, and the marketing authorization holder. Ensera helps bring those elements together into a coherent package that stands up to review.
3) Fewer surprises during review cycles
Multiple review rounds are common in practice. Better upfront organization, tighter justification of applicability, and stronger traceability can reduce back-and-forth and make timelines more predictable.
4) Change readiness across the product lifecycle
As combination platforms grow, changes become normal: new suppliers, packaging updates, process updates, line extensions. Ensera helps keep the evidence trail continuous so that change does not trigger avoidable rework.
Alongside evidence support, Ensera provides the operational services that sit around the launch of a combination product, including Human Factors validation, sterilization management, final assembly, secondary pack, sterile barrier system packing, labeling, and serialization.
This integrated capability helps keep the compliance requirements aligned with the manufacturing and packaging reality, which is critical when programs are moving quickly and change is frequent.
