In the medical device industry, DHR, DMR and DHF are three integral cornerstones of the design control process. However, because these terms overlap each other in letters and in contents and requirements, they are commonly confused. If you are still struggling with the keep these three pillars straight, read on.
DHF – Design History File
A Design History File (DHF) documents the design process from the inception to release of a product. The DHF should either 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 device.
A DHF should contain or reference:
- User needs, product requirements and other design inputs
- Design and development plans
- Risk management plan and report
- Verification and validation protocols and reports
- Design outputs
- Design reviews
- Design transfer materials
- Other design and development documentation
The DHF is a living document, so any updates to the medical device should be documented and updated in the DHF.
DMR – Device Master Record
A Device Master Record (DMR) details all the information necessary for the manufacturing of the medical device, the specific material, equipment, and production requirements of a medical device.
Per the FDA the DMR should contain or reference:
- Design specifications – drawings, composition, formulation, component specs, and software specs
- Production process specifications – equipment specs, and production methods, processes and environment specs
- Quality assurance procedures and specifications – acceptance criteria and quality assurance equipment
- Packaging and labelling specifications – methods and processes used
- Installation, maintenance, and servicing – procedures and methods
A well-documented DHF helps in maintaining a proper DMR with easy reference to files.
DHR – Device History Record
The Device History Record (DHR) documents all production activities for an individual device.
Per the FDA the DHR should contain or reference:
- Date(s) of manufacture
- Quantity manufactured.
- Quantity released.
- Acceptance records demonstrating compliance with the DMR.
- Primary identification label and labelling for each unit.
- Unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used.
In case of audits, the DHR is essential if the investigator wants to compare it against the DMR for compliance or FDA requirements.
The three D’s are crucial for medical device manufacturers to ensure regulatory compliance. All the files and records are interdependent and a lapse in one document can directly affect the others. For more detailed information on DHF, DMR, DHR or DMF, the team of experts at Prime Path Medtech can help you understand the procedures better as well as support you in the documentation process.
The Medical Device Single Audit Program (MDSAP) allows a single regularity audit of a medical device manufacturer’s quality management system (QMS) to fulfil the requirements of multiple regulatory jurisdictions. The participating Regulatory Authorities (RAs) authorize Auditing Organizations (AOs) to conduct these audits. Thus, medical device manufacturers participating in MDSAP can be audited only once and satisfy the regulatory requirements for all the participating RA’s medical device markets. The current participating RAs are:
- Australia’s Therapeutic Goods Administration of Australia
- Brazil’s Agência Nacional de Vigilância Sanitária
- Canada’s Health Canada
- Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
- The United States’ Food and Drug Administration
The MDSAP Official Observers are:
- The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme
- European Union (EU)
The MDSAP Affiliate Members are:
- Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT)
- Republic of Korea’s Ministry of Food and Drug Safety
The MDSAP was developed based on requirements in the IMDRF MDSAP Model with the mission is to “…jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.” By promoting this efficient use of regulatory resources through work sharing and mutual agreements, appropriate regulatory oversight can be achieved while minimizing regulatory burden on industry. Furthermore, the MDSAP promotes consistency, predictability, and transparency of regulatory programs by standardizing the oversight of third-party auditing organizations, the participation of third-party auditing organizations, and the existing requirements and procedures for conformity assessment.
A three-year MDSAP pilot was performed from January 1st, 2014 to December 31st, 2016. Data was collected and summarized in the Final MDSAP Pilot Report. Based on this report, the MDSAP Regulatory Authority Council (the international MDSAP governing body) determined the program’s success. Thus, the final MDSAP was implemented in 2017.
The essential idea of the MDSAP is that a single audit rather than multiple audits by each RA allows for the optimization of time and resources used in the process. Thus, there is significant cost reduction. The MDSAP further provides flexibility to the manufacturers to choose any of the AOs, all of which are monitored by the RAs. Finally, the program uses a standard template for the audit and a single grading process for nonconformities, standardizing preparation strategies and outcomes.
After the successful completion of a MDSAP audit of a medical device manufacturer, the AO provides an audit report to the participating RAs. In the case of nonconformities, the manufacturer presents remediation plans and evidence of implementation of these plans within a specified timeline.Manufacturers that meet all MDSAP regulatory audit criteria are issued a MDSAP certificate that covers the participating RAs.
In the fast-evolving trading world, a singleauditprogram creates a more efficient, effective and effortless process for both the manufacturers and the regulatory bodies.