In order to market a medical device in the United States or the European Union (as well as other regions of the world), a manufacturer must comply with the regulatory body requirements concerning the files and records necessary to prove that a medical device was designed and developed in a manner to maximize its safety and effectiveness while minimizing its risks. In the United States, the “Three Ds” are three required documents/file indexes which are important and often confused. Similar documents are prepared in the European Union. These are described in more detail below.
Design History File (DHF):
In the United States, each manufacturer shall establish and maintain a Design History File (DHF) for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.
This means that there must be a repository or reference to all of the records related to the activities carried out during the design and development process, including:
- User needs and design inputs
- Design outputs generated to build the device
- Design verification and validation protocols and reports
- Records of design reviews performed along the way
Device Master Record (DMR):
In the United States, each manufacturer shall maintain Device Master Records (DMRs). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with 820.40. The DMR for each type of device shall include, or refer to the location of, the following information:
- Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;
- Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
- Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;
- Packaging and labeling specifications, including methods and processes used;
- Installation, maintenance, and servicing procedures and methods.
Device History Record (DHR):
In the United States, each manufacturer shall maintain Device History Records (DHRs). Each manufacturer shall establish and maintain procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information:
- The dates of manufacture;
- The quantity manufactured;
- The quantity released for distribution;
- The acceptance records which demonstrate the device is manufactured in accordance with the DMR;
- The primary identification label and labeling used for each production unit;
- Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used.
Technical File (TF) and Design Dossier (DD):
A Technical File (TF) and Design Dossier (DD) are similar concepts to the DHF in the European Union, which are a requirement for obtaining the CE mark. The TF pertains to products that are Class I, IIa, and IIb, while the DD pertains to Class III medical devices. These documents contain a comprehensive description of your medical device intended to demonstrate compliance with European Union regulatory requirements. These documents read more like a technical report than a file of documents, which is the case for the DHF.
Kymanox can support you with compiling these important medical device documents/file indexes during design and development or retrospectively during remediation, as applicable. Our experts can ensure you have all the necessary contents organized effectively to meet the applicable regulatory body requirements.