The EU Medical Device Regulation (MDR) has significantly reshaped expectations for products at the interface of pharmaceuticals and medical devices. Among its most impactful provisions is Article 117, which introduced a more structured framework for the assessment of integral drug–device combinations (IDDCs).
Article 117 is often framed as an additional regulatory burden. In reality, it is better understood as part of a broader transition towards greater consistency, transparency, and technical depth in regulatory assessment. The requirement for device components to meet safety and performance standards has long existed; what has changed is how this requirement is demonstrated and reviewed - most notably through the formal involvement of Notified Bodies.
As integral drug-device combinations (IDDCs) continue to evolve - incorporating software, on body delivery systems, and increasingly complex risk profiles - Article 117 should be viewed not simply as a compliance exercise, but as a strategic enabler of product robustness, patient safety, and regulatory predictability.
Article 117 – why it matters
At its core, Article 117 requires applicants to demonstrate that the device component of an IDDC complies with MDR Annex I General Safety and Performance Requirements (GSPRs). This can be achieved through one of three routes:
- The use of a CE marked device(s) or device parts.
- Declaration of Conformity for Class I devices.
- Notified Body Opinion (NBOp).
While this framework introduces greater clarity, it does not create an entirely new expectation. Under the previous Medical Device Directive (MDD), compliance with essential requirements was already mandated. However, interpretation and implementation varied, and the absence of a formalised assessment mechanism resulted in fragmented expectations across Member States.
The introduction of Notified Bodies into this process addresses that variability. It ensures that device related aspects are assessed with the same level of technical scrutiny and consistency now expected across the MDR landscape.
The Growing Importance of Device Expertise
The increasing complexity of device technologies embedded within medicinal products has made specialist expertise essential. Today’s IDDCs frequently combine multiple disciplines, from mechanical engineering to software controlled dosing mechanisms.
These products may include features such as:
- On body delivery systems.
- Digitally controlled or time dependent dosing.
- Advanced materials and user interface considerations.
Such complexity demands an assessment approach that extends beyond traditional pharmaceutical evaluation. The formal role of Notified Bodies ensures that device specific risks are systematically identified, assessed, and mitigated, strengthening the overall robustness of the combined product.
From Theory to Practice
Although Article 117 was initially perceived as a new and evolving requirement, it is now firmly embedded in regulatory practice. Across the industry, the Notified Body Opinion has emerged as the dominant pathway for demonstrating conformity. This reflects a broader shift in mindset. Rather than relying on minimal justification routes, organisations are increasingly recognising the value of a structured and independent device assessment - both to meet regulatory expectations and to support product quality.
Demonstrating GSPR Compliance
For many pharmaceutical companies, one of the more significant adjustments under Article 117 is the requirement to present evidence in alignment with MDR expectations. This often requires a shift in documentation structure and terminology. Some principles are particularly important:
- Technical documentation should follow the logic of MDR Annex II, ensuring that evidence is organised, traceable, and clearly linked to each requirement.
- All GSPRs must be considered, even where they are not applicable. In such cases, clear and explicit justification is essential.
It is also important to recognise that overlap between pharmaceutical and device assessments does not imply duplication. Rather, it reflects complementary perspectives. For example, stability will be assessed from both a chemical and a functional standpoint, each addressing different aspects of product performance over time.
Labelling provides another point of intersection. While governed by pharmaceutical legislation, it may also be reviewed by the Notified Body where it functions as a risk control measure -highlighting the need for integrated regulatory thinking.
Classification and Practical Application
Classification of the device component continues to generate discussion. While relevant in determining whether a Notified Body Opinion is required, classification under MDR was not specifically designed for integral products.
In practice, its role is pragmatic rather than determinative - supporting risk understanding and guiding the conformity route. For most IDDCs, the outcome is clear: a Notified Body Opinion will be required, and planning should reflect this from an early stage.
Managing Change
If initial compliance is becoming better understood, the management of post authorisation changes remains an area of ongoing development. Expectations differ depending on the product’s regulatory history, and the distinction between initial opinions and updates is still maturing in practice.
What is clear is that change management under Article 117 requires early planning and cross functional alignment. Timelines for Notified Body review do not always align with pharmaceutical variation procedures, making proactive coordination essential to avoid delays.
The Role of Documentation Quality
One consistent insight across Notified Bodies is the direct relationship between documentation quality and review efficiency. Well structured, well justified submissions enable smoother assessments and more predictable timelines.
In practice, this means:
- Clear mapping of GSPRs to supporting evidence.
- Strong justification of applicability decisions.
- Early and effective engagement with device suppliers.
Organisations that invest in these areas are better positioned not only to meet timelines, but to reduce regulatory friction across the product lifecycle.
Planning for Success
With appropriate preparation, Article 117 requirements can be integrated effectively into development programmes. Early engagement with the Notified Body, realistic timeline planning, and recognition of the device component as an integral part of the product are all critical.
Where these elements are in place, the NBOp process becomes both manageable and predictable - supporting timely market access without compromising on quality.
Beyond Compliance: Building Confidence in Combination Products
Article 117 reflects a broader evolution in healthcare, where innovation increasingly sits at the intersection of drugs and devices. In this context, regulatory expectations are not simply increasing - they are becoming more integrated and more technically demanding.
Organisations that respond by building internal expertise, strengthening technical documentation, and engaging proactively with Notified Bodies will not only achieve compliance, but also enhance product quality, patient safety, and long term resilience.
Regulatory excellence, in this environment, is no longer just a requirement. It is a differentiator.
Why choose BSI
BSI has been at the forefront of Article 117 implementation, issuing the first Notified Body Opinions under the MDR and developing deep experience across a wide range of combination products.
Our medicinal and biologics specialists bring extensive expertise across drug development, GMP systems, and Quality by Design, supporting scientifically robust and regulator aligned assessments.
From the 18th Survey with data status 31 October 2025:
Total number of applications for Article 117 MDR opinions received: 468 | BSI 60%
Total number of applications for Article 117 MDR opinions issued: 369 | BSI 75%
To further support manufacturers, BSI offers a Dedicated Interactive Review Service, providing structured, real time engagement between technical experts and applicants. This approach enhances clarity, improves timeline predictability, and supports a more efficient review process -helping organisations navigate Article 117 with confidence.
At BSI our average timing for issuance of a NBOp from the assessment start date is 34 days* for dedicated service and 74 days* for our standard service.
*BSI publishes our Lead-Times on a quarterly basis.
Register for our Article 117 dedicated webinar on the 16 of July.
Theresa Jeary, Head of Medicinal & Biologics, Regulatory Services, BSI
