For pharmaceutical and combination product manufacturers, Article 117 of the Medical Device Regulation introduced a significant regulatory requirement that continues to generate questions across the industry. Organisations developing medicinal products that incorporate a medical device constituent must now demonstrate that the device component complies with the relevant General Safety and Performance Requirements (GSPRs) of the MDR when the device is not already CE marked.
This requirement is fulfilled through the Notified Body Opinion process, often referred to as the NB Opinion or NBOp process. Unlike a traditional MDR conformity assessment, Article 117 is not intended to result in CE certification of the device. Instead, it provides an independent assessment of the device constituent that supports the medicinal product’s Marketing Authorisation Application (MAA) or variation submission.
Understanding how the Notified Body Opinion process differs from a standard MDR submission is essential for pharmaceutical companies, combination product manufacturers and regulatory teams seeking to avoid unnecessary documentation, delays and costs.
What Is an Article 117 Notified Body Opinion?
Article 117 applies to medicinal products that incorporate a device constituent where the medicinal product delivers the primary mode of action and the device itself is not separately CE marked.
Under this framework, a Notified Body reviews the device constituent to determine whether it complies with the applicable MDR Annex I General Safety and Performance Requirements. The resulting opinion is then included as part of the Marketing Authorisation Application submitted to the European Medicines Agency or relevant national competent authority.
The purpose of the assessment is not to certify the device independently. Instead, it provides assurance that the device component incorporated into the medicinal product satisfies the relevant medical device safety and performance expectations.
This approach creates a bridge between pharmaceutical regulation and medical device regulation, ensuring that combination products are assessed appropriately while avoiding duplication of regulatory oversight.
How the Notified Body Opinion Process Differs from a Standard MDR Submission
One of the most common misconceptions is that an Article 117 submission is simply a smaller version of a normal MDR conformity assessment.
In reality, the objectives of the two processes are fundamentally different. A standard MDR submission is designed to achieve CE certification and market access for a standalone medical device. The assessment evaluates the complete device lifecycle, including quality management systems, post-market surveillance processes and ongoing regulatory obligations.
The Article 117 process has a much narrower focus. The assessment is limited to the device constituent within the medicinal product and evaluates compliance with applicable GSPRs relevant to that specific use. Instead of receiving an MDR certificate, manufacturers receive a Notified Body Opinion report that supports the medicinal product application. The outcome is therefore an expert regulatory opinion rather than a device certification.
What Documentation Is Typically Required?
Although Article 117 submissions are more focused than full MDR technical documentation packages, manufacturers must still provide sufficient evidence to demonstrate compliance. A clear device description and intended purpose should be included, explaining the role of the device constituent within the medicinal product. The GSPR checklist is often considered the most important document within the submission package. It should be comprehensive, clearly justified and fully traceable to supporting evidence.
Risk management documentation is also required. However, unlike a standalone medical device submission, risk management activities must consider both the device itself and the interaction between the device and medicinal product. Manufacturers should demonstrate that risks arising from the combined use of the product have been appropriately identified, assessed and controlled. Additional documentation may include design verification and validation evidence, biocompatibility data, usability information where applicable, performance testing and evidence supporting compatibility between the medicinal product and device constituent.
Relevant standards should be identified clearly, along with justifications explaining how compliance has been demonstrated.
Risk Management Considerations
Risk management is one of the areas where Article 117 submissions differ most significantly from traditional medical device submissions. The assessment must consider the device constituent in the context of the complete combination product. The interaction between the device, medicinal product, user and clinical environment must also be considered.
Risk analyses should therefore address device functionality, drug delivery performance, user interaction and potential failures arising from the combined system. Manufacturers should ensure that risk management documentation clearly demonstrates how these integrated risks have been assessed and controlled throughout development.
Working with Device Suppliers
Many combination product manufacturers do not design or manufacture the device constituent themselves. Instead, the device component is frequently supplied by a specialist subcontractor or device manufacturer. This creates a practical challenge because pharmaceutical companies may not have access to the supplier’s complete technical documentation. Fortunately, Article 117 submissions do not always require every underlying design document.
In many cases, evidence of the supplier’s quality processes, quality agreements, summaries of testing activities and supporting compliance documentation may be sufficient. The key objective is demonstrating compliance with applicable GSPRs rather than reproducing the entire technical file. Effective collaboration between pharmaceutical companies and device suppliers is therefore critical to successful submissions.
Why Early Engagement with the Notified Body Matters
One of the strongest recommendations emerging from practical Article 117 experience is the importance of early engagement with the chosen Notified Body. Open communication before submission helps clarify expectations, identify potential concerns and avoid unnecessary documentation requests later in the process. Early discussions can also influence timelines, project planning and overall costs.
Notified Bodies often have different areas of expertise and varying approaches to combination product assessments. Speaking with reviewers in advance helps ensure that submission strategies align with expectations from the outset. For complex products, these discussions can significantly improve efficiency and reduce the likelihood of avoidable delays.
Common Challenges During Article 117 Submissions
Manufacturers frequently underestimate the importance of the GSPR checklist.
The assessment focuses heavily on demonstrating compliance with Annex I requirements, weak justifications or incomplete mappings often create review challenges.
Another common issue arises when organisations fail to address combination product specific risks adequately. Risk management documentation that focuses only on the device without considering interaction with the medicinal product is often insufficient. Difficulties obtaining information from device suppliers can also create delays. Establishing clear information-sharing arrangements early in development helps mitigate this risk. Finally, many organisations mistakenly prepare submissions as if they were full MDR technical files, creating unnecessary complexity and increasing preparation time.
LFH supports pharmaceutical and combination product manufacturers throughout the Article 117 Notified Body Opinion process. Our team helps organisations prepare robust GSPR checklists, risk management documentation, technical evidence packages and regulatory strategies that support efficient submissions and successful Marketing Authorisation Applications.
FAQs – Article 117
What is an Article 117 Notified Body Opinion?
It is an independent assessment of a device constituent within a medicinal product to demonstrate compliance with applicable MDR General Safety and Performance Requirements.
Does an Article 117 submission result in CE marking?
No. The outcome is a Notified Body Opinion report rather than an MDR certificate.
Who needs an Article 117 Notified Body Opinion?
Manufacturers of medicinal products containing non-CE marked device constituents where the medicinal product provides the primary mode of action.
Do I need a full MDR technical file?
No. Only documentation necessary to demonstrate compliance with relevant GSPRs is generally required.
Is a separate MDR quality management system audit required?
No. There is no standalone MDR certification audit associated with the Article 117 process.
Why is the GSPR checklist important?
The GSPR checklist forms a central part of the assessment and demonstrates how the device constituent complies with applicable MDR requirements.
