EU MDR Article 117 Compliance 2026: Preparing For Successful Notified Body Opinions For Drug-Device Combination Products

How Article 117 Compliance, Notified Body Opinions, Technical Documentation, Regulatory Strategy, Drug-Device Classification, and Submission Readiness Are Supporting Successful EU Market Access

Drug-device combination products present unique regulatory challenges under the EU Medical Device Regulation (EU MDR) 2017/745. For medicinal products incorporating a medical device, obtaining a Notified Body Opinion (NBO) under Article 117 has become a critical regulatory requirement for demonstrating compliance before marketing authorization.

Securing a positive Notified Body Opinion requires more than submitting technical documentation. Manufacturers must develop a well-defined regulatory strategy, accurately classify the product, demonstrate compliance with the applicable General Safety and Performance Requirements (GSPRs), and prepare comprehensive technical documentation that satisfies both medicinal product and medical device requirements.

As regulatory expectations continue to evolve, pharmaceutical companies, medical device manufacturers, combination product developers, and regulatory professionals should strengthen submission planning, technical documentation, regulatory intelligence, and engagement with notified bodies to minimize review delays and support successful market access.

Why Article 117 Compliance Is a Strategic Priority

The introduction of Article 117 under the EU MDR has strengthened regulatory oversight of drug-device combination products, ensuring that device components meet applicable medical device requirements before medicinal product approval.

Key drivers include:

• Stronger patient safety requirements 
• Increased regulatory scrutiny 
• Harmonized EU regulatory framework 
• Improved product quality 
• Enhanced technical documentation 
• Greater lifecycle compliance 
• Better risk management 
• Increased collaboration with notified bodies 
• Efficient regulatory submissions 
• Faster market access planning 

Without an effective regulatory strategy, organizations may encounter:

• Delayed Notified Body Opinions 
• Deficiency letters 
• Incomplete technical documentation 
• Product classification challenges 
• Extended review timelines 
• Additional regulatory questions
• Submission delays 
• Increased compliance costs 
• Market entry postponements 
• Commercial risks 

Early preparation significantly improves submission quality and regulatory success.

Executive Overview

Successful Article 117 compliance requires an integrated regulatory approach combining pharmaceutical and medical device expertise.

Organizations should establish compliance programs covering:

• Article 117 requirements 
• Product classification 
• Regulatory strategy 
• Technical documentation 
• GSPR compliance 
• Risk management 
• Clinical and performance evidence 
• Quality Management Systems (QMS) 
• Regulatory intelligence 
• Submission planning 
• Lifecycle management 
• Notified Body engagement 

Companies adopting these capabilities can reduce regulatory risks while improving submission efficiency and market access.

Understanding Article 117 Under the EU MDR

Article 117 applies to medicinal products that incorporate a medical device as an integral part of the product.

Where the device component does not already have a CE Certificate covering its intended use, applicants must obtain a Notified Body Opinion confirming that the device complies with the relevant General Safety and Performance Requirements (GSPRs) of the EU MDR.

The Article 117 process focuses on:

• Device compliance 
• Product safety 
• Risk management 
• Performance evaluation 
• Manufacturing quality 
• Technical documentation 
• Clinical evidence 
• Regulatory conformity 
• Lifecycle compliance 
• Patient protection 

Key Regulatory Authorities

Core Article 117 Requirements

Manufacturers should prepare comprehensive documentation covering:

• Product classification 
• Intended purpose 
• Device description 
• Technical documentation 
• General Safety and Performance Requirements (GSPR) 
• Risk Management File 
• Clinical and performance evidence 
• Manufacturing information 
• Quality Management System 
• Verification and validation 
• Labelling 
• Instructions for Use (IFU) 

Complete and well-structured documentation helps reduce review cycles and supports efficient regulatory assessment.

Regulatory Classification

Accurate classification is fundamental to a successful Article 117 submission.

Organizations should determine:

• Whether Article 117 applies 
• Device classification 
• Product regulatory pathway 
• Applicable conformity assessment route 
• Relevant MDR requirements 
• GSPR applicability 
• Technical documentation scope 
• Supporting evidence requirements 

Incorrect classification may result in unnecessary delays or additional regulatory reviews.

Why Early Regulatory Strategy Matters

A proactive regulatory strategy enables organizations to align medicinal product and device requirements from the beginning of product development.

Early planning supports:

• Efficient submission preparation 
• Improved documentation quality 
• Better risk management 
• Effective Notified Body engagement 
• Reduced Regulatory Questions 
• Faster review timelines 
• Improved cross-functional collaboration 
• Stronger lifecycle compliance 

Establishing regulatory strategy early helps minimize compliance risks while supporting successful EU market access.

Technical Documentation Requirements

A successful Article 117 submission depends on complete, accurate, and well-organized technical documentation.

Key documentation typically includes:

• Device description 
• Design information 
• Manufacturing processes 
• GSPR checklist 
• Risk Management File 
• Clinical evaluation or supporting evidence 
• Verification and validation data 
• Usability information 
• Biological safety 
• Sterilization information (where applicable) 
• Labelling 
• Instructions for Use (IFU) 

High-quality technical documentation supports efficient review by notified bodies.

Working Effectively with Notified Bodies

Early and transparent engagement with notified bodies can significantly improve submission outcomes.

Best practices include:

• Early regulatory planning 
• Clear product classification 
• Complete documentation 
• Timely responses to questions 
• Effective communication 
• Gap assessments 
• Internal technical reviews 
• Cross-functional collaboration 

Strong collaboration helps reduce review timelines and improve submission quality.

Submission Readiness

Before submission, organizations should verify:

• Article 117 applicability 
• Technical documentation completeness 
• GSPR compliance 
• Risk management documentation 
• Clinical evidence 
• Quality system compliance 
• Manufacturing readiness 
• Labelling compliance 
• Regulatory strategy 
• Internal review completion 

Submission readiness assessments help identify gaps before regulatory review.

Regulatory Intelligence

Organizations should continuously monitor:

• EU MDR updates 
• European Commission guidance 
• MDCG guidance documents 
• EMA publications 
• Notified Body expectations 
• Article 117 interpretation 
• GSPR guidance 
• Clinical evaluation requirements 
• Post-market surveillance updates 
• Regulatory best practices 

Regulatory intelligence supports proactive compliance and better submission planning.

Readiness Assessment

Best Practices

Organizations should:

• Develop an early regulatory strategy 
• Confirm Article 117 applicability 
• Prepare robust technical documentation 
• Conduct gap assessments 
• Strengthening risk management 
• Ensure GSPR compliance 
• Maintain strong QMS 
• Engage notified bodies early 
• Monitor EU MDR updates 
• Train regulatory teams 

Common Mistakes

Avoid:

• Incorrect product classification 
• Incomplete technical documentation 
• Weak risk management files 
• Delayed notified body engagement 
• Poor GSPR mapping 
• Insufficient clinical evidence 
• Weak regulatory planning 
• Inadequate internal reviews 
• Delayed responses to queries 
• Ignoring regulatory updates 

Future Trends

Emerging developments include:

• Greater Article 117 experience across industry 
• Enhanced MDR guidance 
• Stronger technical documentation expectations 
• Increased regulatory harmonization
• Digital submission processes 
• Risk-based conformity assessments 
• Improved lifecycle management 
• Greater collaboration with notified bodies 
• Expanded regulatory intelligence 
• Continued focus on patient safety 

Business Benefits

Conclusion

Obtaining a successful Notified Body Opinion under Article 117 requires more than technical documentation it demands a well-planned regulatory strategy, accurate product classification, robust GSPR compliance, comprehensive risk management, and effective collaboration with notified bodies.

By strengthening submission readiness, regulatory intelligence, and lifecycle compliance, organizations can minimize regulatory delays, improve submission quality, and accelerate market access for drug-device combination products across the European Union.

Why Choose Maven Regulatory Solutions?

Maven Regulatory Solutions provides comprehensive regulatory consulting for pharmaceutical, medical device, and combination product manufacturers navigating EU MDR Article 117 requirements.

Our expertise includes regulatory strategy, Article 117 gap assessments, product classification, technical documentation preparation, GSPR compliance, risk management, quality systems, notified body submission support, regulatory intelligence, and lifecycle management.

We help organizations achieve successful Notified Body Opinions while reducing regulatory risks and supporting efficient EU market access.

Frequently Asked Questions

1. What is EU MDR Article 117?
A requirement for certain drug-device combination products to obtain a Notified Body Opinion before EU marketing authorization.

2. When does Article 117 apply?
It applies when a medicinal product incorporates a medical device that does not already have a CE certificate covering its intended use.

3. What is a Notified Body Opinion (NBO)?
An assessment confirming that the device component complies with the applicable EU MDR General Safety and Performance Requirements (GSPRs).

4. Who is affected by Article 117?
Pharmaceutical companies, medical device manufacturers, combination product developers, and marketing authorization applicants.

5. What documentation is required?
Technical documentation, GSPR compliance evidence, risk management files, clinical/performance data, labelling, and Quality Management System (QMS) information.

6. Why is product classification important?
Correct classification determines whether Article 117 applies and the appropriate regulatory pathway.

7. What should companies do before submission?
Confirm Article 117 applicability, complete technical documentation, ensure GSPR compliance, and conduct submission readiness reviews.

8. Why is early engagement with a Notified Body important?
It helps identify regulatory gaps early, reduces review delays, and improves submission quality.

9. Why is regulatory intelligence important?
It helps organizations stay updated on EU MDR, MDCG guidance, Article 117 expectations, and evolving regulatory requirements.

10. How can Maven Regulatory Solutions help?
Maven supports Article 117 gap assessments, regulatory strategy, product classification, technical documentation, GSPR compliance, risk management, Notified Body submissions, regulatory intelligence, and lifecycle management.