Class I Medical Device Manufacturers Need an established QMS Under the New MDR
Understanding MDR Technical Documentation: Ensuring Compliance and Patient Safety
Compliance with the EU MDR 2017/745 is mandatory for companies supplying medical devices to the EU market. One of the most important requirements of the regulation is technical documentation—a key pillar of quality management that ensures the safety, performance and compliance of medical devices. To help you understand and apply the guidance, we have put together a summary of MDR Technical Documentation. Read our blog below to learn more.
Why is Technical Documentation Required?
The purpose of technical documentation is to demonstrate the safety, performance, and intended use of a medical device. It is a comprehensive collection of documents that provide in-depth information on a medical device such as its design and manufacturing specifications, clinical evaluation, performance data, labelling, and instructions for use.
MDR requires that manufacturers create and maintain this documentation for every medical device they produce. MDR also requires the documentation to be made available to the appropriate authorities upon request. It must also be kept up-to-date and any changes made to the device must be properly documented and assessed for their impact on safety and performance. This means that manufacturers must have a robust system in place for managing technical documentation throughout the entire lifecycle of the device.
Summary of the Requirements of MDR Technical Documentation
Device description and specification, including variants and accessories
The purpose of this section is to provide an in-depth description of the device including how it would be used and details of any specific features or characteristics. The description should also include information on any variants or accessories that are available for the device, as well as any potential interactions with other devices or materials. Examples of documents could be a general product description.
Information to be supplied by the manufacturer
Manufacturers must provide information to users that allow them to use the device safely and effectively. This section should include further information on how to use the device properly as well as handling, storage, and maintenance advice. In addition, manufacturers should include precautions or warnings that users should be aware of. The information should be clear, concise, and easy to understand. Examples of documents could be Instructions for use (IFU), user manual, product labels.
Design and manufacturing information
This section should detail the design and manufacturing processes used to create the device, including any relevant drawings, diagrams, or specifications. The documentation must demonstrate that the device has been manufactured and designed to meet all applicable requirements of the MDR. This includes any safety and performance requirements that may apply to the device. Examples of documents could be a design and development plan, design input and output matrix, design reviews.
General safety and performance requirements
The purpose of this section is to demonstrate that the device complies with the general safety and performance requirements specified in Annex I of MDR. Manufacturers are required to present a comprehensive assessment of the safety and performance features of the device, describe the potential risks involved in its usage, and the measures taken to reduce these risks. For this part the general safety and performance requirements (GSPR) checklist is used.
Benefit-risk analysis and risk management
Manufacturers must conduct a thorough benefit-risk analysis of the device to assess its overall safety and effectiveness. This section should include an analysis of the risks associated with the device, including any potential hazards, and how these risks are managed and mitigated. It should also describe the procedure employed for clinical evaluation to establish the device’s safety and efficacy. Examples of documents could be a risk management plan, hazard traceability matrix, risk management report.
Product verification and validation
This section should provide evidence that the device has been tested and validated to ensure that it meets the safety and performance requirements set out in the MDR. The documentation should include information on the test methods used, the results obtained, and any actions taken to address any issues that were identified during the testing process. Examples of documents could be a clinical evaluation plan and report, biological evaluation plan and report, verification and validation plan and report)
The Importance of MDR Technical Documentation in Medical Device Compliance
Technical documentation is a critical component of MDR. It ensures that medical devices are designed, manufactured, and marketed in a safe and transparent manner. It also provides the necessary information for regulatory authorities to assess the safety and performance of these devices. Manufacturers must take great care in creating and maintaining technical documentation to comply with MDR and to ensure the safety of patients who rely on these medical devices.
Create, manage, and maintain your mdr technical documentation with MedQdoc
MedQdoc is a software platform that helps medical device manufacturers manage their technical documents and records in a structured and efficient way. It offers several features that support the creation and maintenance of technical documentation for your medical devices, ensuring that they are organised and easily accessible. These features include document management, traceability and version control, collaboration, regulatory compliance, design control documentation, risk management documentation and post-market surveillance.
- Document management: MedQdoc allows users to create, manage, and store all required documentation. Some examples include product and process documentation, risk management files, and clinical evaluations.
- Traceability and version control: MedQdoc ensures traceability and version control for all documents. This enables users to track changes and updates, ensuring that the latest version of the documentation is always available.
- Collaboration: MedQdoc supports collaboration among team members and external stakeholders by providing a centralised platform for communication, document sharing, and task management.
- Regulatory compliance: MedQdoc helps users ensure regulatory compliance by providing templates and checklists for key documents, such as technical files and clinical evaluations, ensuring that all required information is included and up-to-date.
- Design control documentation: MedQdoc provides a comprehensive framework for documenting design control activities, including design inputs, design outputs, design verification and validation, design reviews, and design changes. This helps ensure that the design stages applied to the device are well-documented and can be easily understood by all stakeholders.
- Risk management documentation: MedQdoc facilitates the development and documentation of risk management plans, risk assessments, and risk control activities. This allows the design stages applied to the device to be evaluated and managed based on potential risks.
- Post market surveillance: MedQdoc allows easy recording of the device’s post-market surveillance plans and activities, including how they are being carried out and any results obtained.
Overall, MedQdoc helps medical device manufacturers ensure that their technical documentation is comprehensive, accurate, and up-to-date, while also streamlining the documentation process and enabling efficient collaboration among team members.
MedQdoc is a powerful tool that can help you create, manage, and maintain your MDR technical documentation in compliance with the latest regulations. Whether you are a small start-up or a large medical device manufacturer, MedQdoc can simplify the process and save you time and resources. With MedQdoc, you can ensure traceability, version control, and collaboration across your team, while also benefiting from features such as regulatory compliance templates, design control documentation, risk management documentation, and post-market surveillance support. Don’t let the complexities of MDR technical documentation slow you down.
Contact MedQtech today to learn how MedQdoc can support your needs.
MedQdoc is used across the medical device industry
