Design Dossier

Medical device companies seeking entry to the European marketplace must compile a technical file or design dossier and submit it to a Notified Body for review.

Medical device design dossiers play an important role in the regulatory process for medical device manufacturers selling their products within the European marketplace. These manufacturers must follow the appropriate regulatory pathway for obtaining a CE marking, which certifies their medical device to be sold in Europe.

Companies must begin by establishing a quality management system in compliance with the ISO 13485:2016 medical device quality standard, which then must be audited by a Notified Body. Once the medical device has been adequately tested, the company must compile a technical file or design dossier that demonstrates that the product complies with the design specifications established during the product development process.

The design dossier must be submitted to a Notified Body for approval, so it is important that medical device companies understand the formatting guidelines for their design dossier and what information to include.

FREE DOWNLOAD: Click here to download our Definitive Guide to ISO 14971 Risk Management for Medical Devices.

The Difference Between a Technical File and a Design Dossier

There has been some confusion regarding the difference between a technical file and a design dossier for medical devices. The terminology for these documents can vary depending on the regulatory directive and specific annex being referenced. Technical files, sometimes referred to as technical documentation, are required for all Class I, Class IIa and Class IIb medical devices. Design dossiers refer to the technical documentation for Class III devices.

Medical device companies are required to produce and maintain technical files for all of their products, and these documents are subject to review by Competent Authorities and Notified Bodies. Design dossiers are meant to be submitted to Notified Bodies for a design examination prior to obtaining a CE marking.

Contents of a Design Dossier for Medical Devices

The purpose of a design dossier is to facilitate a design examination by a Notified Body whose goal is to verify that your medical device conforms to its technical specifications. When these design examinations are delayed, the most common cause is that the medical device company failed to provide sufficient information, or that the information needed could not be found within the design dossier.

Here's an overview of how to organize your design dossier for submission:

• Start with administrative information - include the manufacturer's name and address, the name and location of your EU representative, the file status and revision history, and which medical device directives apply to your specific product. You should also mention the classification of your device, any unique identifiers or product codes, and reference any previous submissions relevant to your device.

• Deliver detailed technical documentation- the goal of your design dossier is to prove that your product meets technical specifications, so you'll be supplying a lot of technical documentation to make your case, including a drafted declaration of conformity. You should include a description of your device and its intended use, along with any market history or sales data you may have collected.  Your technical documentation should also reference:
  • Essential device requirements
  • Manufacturing processes
  • User information, e.g. brochures, marketing, instructions and labels
  • Design verification and validation
  • Risk management
  • Clinical evaluations and data
  • Post-market surveillance plan
  • Sterilization validation
  • Packaging
  • Shelf life testing
  • Product End-of-life and disposal considerations
  • Software validation

Build Your Design Dossier with Greenlight Guru

Medical device companies that rely on paper-based quality systems face significant challenges when constructing a design dossier. Documents must be pulled and transferred from various computer files for inclusion in the design dossier, and there's no way to ensure that all of the documents are kept up-to-date all the time.

With Greenlight Guru's medical device QMS software, companies can establish a secure, cloud-based QMS with features such as advanced document control and management that make it easy to maintain and produce up-to-date technical documentation during audits. With just a few clicks, medical device companies can access all existing technical documentation, which can be compiled into a design dossier and then submitted to a Notified Body.

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