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MDR Article 117 Consulting Services

Cert3Global provides expert MDR Article 117 consulting services for manufacturers of medicinal products that incorporate medical devices as integral components. Our regulatory experts help you navigate EU MDR requirements, prepare the required technical documentation, and support interactions with Notified Bodies to ensure compliance and successful market authorization.

Whether you are developing a new drug-device combination product or updating an existing product to meet MDR requirements, our team provides practical and compliant solutions to streamline your regulatory journey.

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Get Article 117 Support

Expert MDR Article 117 Support for Drug-Device Combination Products

EU MDR Article 117 introduced new requirements for medicinal products that incorporate medical devices as an integral part of the product. Manufacturers are required to demonstrate that the device component complies with the applicable General Safety and Performance Requirements (GSPRs) under MDR.

These requirements have significantly changed the regulatory pathway for many drug-device combination products. Manufacturers now need comprehensive technical documentation and, in many cases, an opinion from a Notified Body confirming compliance of the device constituent.

Cert3Global provides structured MDR Article 117 consulting services to help manufacturers understand these obligations, prepare compliant documentation, and manage the regulatory process efficiently. Our goal is to simplify complex requirements while helping you achieve successful market authorization.

What is MDR Article 117?

MDR Article 117 is a provision under Regulation (EU) 2017/745 that applies to medicinal products incorporating medical devices as integral components. The regulation requires manufacturers to demonstrate that the device part of the product complies with applicable MDR requirements.

Where the device component does not already hold a CE certificate, manufacturers may need to obtain an opinion from a Notified Body regarding conformity with the General Safety and Performance Requirements (GSPRs).

Examples of products that may fall under Article 117 include:

  • Prefilled syringes
  • Drug-eluting injectors
  • Metered-dose inhalers
  • Insulin pens
  • Combination products containing integrated delivery systems
The purpose of Article 117 is to ensure that the device constituent of combination products meets the same safety and performance expectations as standalone medical devices.

Why is MDR Article 117 Important?

MDR Article 117 is critical because it establishes a clear regulatory framework for drug-device combination products entering the European market.
Failure to meet Article 117 requirements can result in:
  • Delays in market authorization applications
  • Additional regulatory questions and documentation requests
  • Increased compliance costs
  • Delayed product launches
  • Potential market access challenges
By implementing a well-planned Article 117 strategy, manufacturers can reduce regulatory risks and improve submission readiness.

Key Benefits:

  • Supports compliance with EU MDR requirements
  • Facilitates medicinal product authorization procedures
  • Demonstrates safety and performance of the device constituent
  • Reduces regulatory uncertainties and delays
  • Improves submission quality and readiness
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MDR Article 117 Services You Can Rely On

Cert3Global provides practical and end-to-end support for manufacturers of drug-device combination products, helping ensure compliance with MDR Article 117 requirements.

Gap Assessment & Regulatory Strategy

We evaluate your product and identify applicable Article 117 requirements, developing a clear and practical regulatory strategy.

Technical Documentation Review

We assess and organize technical documentation for the device constituent, ensuring alignment with MDR General Safety and Performance Requirements.

GSPR Compliance Support

Our experts help prepare and review documentation demonstrating conformity with applicable GSPRs.

Notified Body Coordination

We support communication and documentation requirements for obtaining the Notified Body opinion required under Article 117.

Submission Readiness Support

We review documentation packages to identify gaps and improve readiness before regulatory submission.

Regulatory Guidance Throughout the Project

Our consultants provide ongoing support throughout the Article 117 process, helping manufacturers address regulatory questions and documentation requirements efficiently.

MDR Article 117 Process

Achieving compliance with MDR Article 117 typically involves the following steps:
  • Determine whether the product falls within the scope of Article 117.
  • Identify the applicable General Safety and Performance Requirements.
  • Prepare technical documentation for the device constituent.
  • Conduct a gap assessment and resolve compliance deficiencies.
  • Engage with a Notified Body when required.
  • Obtain the necessary Notified Body opinion.
  • Include the documentation within the medicinal product authorization dossier.
A structured approach helps manufacturers avoid delays and ensures that documentation is prepared in accordance with regulatory expectations.

Who Needs MDR Article 117 Consulting Services?

MDR Article 117 consulting services are particularly beneficial for:
  • Pharmaceutical companies developing drug-device combination products
  • Manufacturers of prefilled syringes and injectors
  • Manufacturers of inhalation devices integrated with medicinal products
  • Companies seeking EU market authorization for combination products
  • Organizations requiring Notified Body involvement under MDR Article 117
Manufacturers unfamiliar with the updated regulatory requirements often benefit from expert guidance to ensure compliance and avoid unnecessary delays.

Why Choose Cert3Global?

Cert3Global provides focused MDR Article 117 consulting services designed to simplify compliance and improve submission readiness
We provide:
  • Regulatory strategy for Article 117 compliance
  • Technical documentation support
  • GSPR assessment and documentation review
  • Notified Body coordination assistance
  • Practical guidance from experienced regulatory consultants
  • End-to-end support throughout the project lifecycle
Our approach emphasizes regulatory clarity, accurate documentation, and efficient project execution, helping manufacturers confidently navigate MDR Article 117 requirements.

Start Your MDR Article 117 Compliance Journey!

MDR Article 117 introduces additional regulatory requirements for medicinal products that incorporate medical devices. Proper planning, technical documentation, and regulatory strategy are essential for successful compliance.

Cert3Global supports manufacturers throughout the process, helping ensure that the device constituent meets MDR requirements and that regulatory submissions are prepared with confidence.

Book a Free 15-Minute Compliance Call

FAQs

What is MDR Article 117?
MDR Article 117 is a provision under Regulation (EU) 2017/745 that applies to medicinal products containing medical devices as integral components and requires compliance of the device constituent with applicable MDR requirements.
Products such as prefilled syringes, insulin pens, inhalers, and other integrated drug-device combination products may fall under Article 117 requirements.

A Notified Body opinion may be required if the device constituent does not already hold an appropriate CE certificate.

Manufacturers generally need technical documentation demonstrating conformity with applicable General Safety and Performance Requirements.
Yes. Cert3Global provides end-to-end MDR Article 117 consulting services, including gap assessments, technical documentation support, GSPR evaluations, and Notified Body coordination.

Disclaimer

Cert3Global provides regulatory consulting and UK Responsible Person services for cosmetics. Compliance outcomes and market access remain subject to applicable UK cosmetic regulations.