Medical Device File
Medtech Product Development Compliance to Local & Global Regulatory Requirements
HSA has recently set up an Innovation Office, a regulatory advisor for product development, in pursuit of greater efficiency in the development and registration of therapeutic products. This will greatly shorten the time needed for product development by providing professional advice to relevant industries and create a more diverse market for clinical treatments. The Innovation Office is a move that will encourage key players to be more proactive in their development of clinical products and drive the progress of the medical industry.
ARQon has also released a Global Regulatory Strategy that will facilitate a smoother process of product development by helping companies understand the necessary regulatory requirements, the required resources and the estimated timeline to register and seek approval from the local authority of the countries of interest.
For the Product Development and Product Registration in Asia and Global Article click here
Typically, manufacturers must meet the design control requirements and build DHF, DMR, DHR for all classes with the exception of certain Class 1 devices.
A) DESIGN HISTORY FILE (DHF)
21 CFR 820.3(e) provides the definition of DHF:
Design history file (DHF) means a compilation of records which describes the design history of a finished device.
21 CFR 820.30
(1) Each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a)(2) of this section, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.
(2) The following class I devices are subject to design controls:
(i) Devices automated with computer software, and
(ii) The devices listed in the following chart.
(b) Design and development planning. Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves.
(c) Design input. Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.
(d) Design output. Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified. Design output shall be documented, reviewed, and approved before release. The approval, including the date and signature of the individual(s) approving the output, shall be documented.
(e) Design review. Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF).
(f) Design verification. Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF.
(g) Design validation. Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF.
(h) Design transfer. Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.
(i) Design changes. Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.
(j) Design history file. Each manufacturer shall establish and maintain a 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.
These design controls requirements are described in the sections (b) to (i) of 21 CFR 820.30. Steps of a design process includes:
Design and Development Planning,
Summary: DHF contains the records, which provide evidence that the design controls requirements are met, following the design process steps.
B) DEVICE MASTER RECORD (DMR)
21 CFR 820.3(j) provides the definition of DMR:
Device master record means a compilation of records containing the procedures and specifications for a finished device.
21 CFR 820.181 states:
Each manufacturer shall maintain device master records (...) The DMR for each type of device shall include, or refer to the location of, the following information:
Production process specifications,
Quality assurance procedures,
Packaging and labeling specifications,
Installation, maintenance, and servicing procedures and methods.
Summary: DMR is a comprehensive record of all the procedures, instructions and specifications required to manufacture a device. It contains the documents or locations of documents for manufacturing and servicing a device.
C) DEVICE HISTORY RECORD (DHR)
21 CFR 820.3(i) provides the definition of DHR:
Device history record (DHR) means a compilation of records containing the production history of a finished device.
21 CFR 820.184 states:
Each manufacturer shall maintain device history records (...) maintain procedures to ensure that DHR’s 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:
(a) The dates of manufacture;
(b) The quantity manufactured;
(c) The quantity released for distribution;
(d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR;
(e) The primary identification label and labeling used for each production unit; and
(f) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used.
Summary: DHR is the log file of what was produced and the proofs that it was produced respecting plans/procedures/instructions found in the DMR.