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 which 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.
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.
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:
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.