Relevance to CE Marking of Medical Devices Technical Documentation
Technical documentation is a useful tool in support of getting CE marking for medical devices. The I3CGLOBAL team works with the medical device and IVD industry and knows how important it is for regulatory compliance, process flows, and mistake prevention.
1: Importance of medical device technical descriptions
In the world of the medical device industry, technical documentation is an invaluable resource. It gives a close look at many medical devices by examining the design, production and development processes of these products. This documentation is proof that you comply with the European MDR Regulation and Invitro diagnostic device regulation / IVDR Regulation and as a result, notified body approval
Technical documentation allows manufacturers to ensure their devices meet the essential requirements: (1) intended use; (2) design specifications and other information about its operation, every component with substantial manufacturing processes.
Regulatory compliance through full audit trail
The MDR 2017/745 has laid down strict stipulations as to what conditions a medical device manufacturer needs to meet before they get their CE mark. Compliance, and documenting that compliance (daily), is the living nightmare of medical device quality. Technical documentation sits at its core.
Technical documentation allows manufacturers to demonstrate that their products comply with the general requirements of basic safety and performance through a detailed description of its intended purpose, design & construction, as well as information on verification data. This makes sure that the device is safe and effective for what it is intended to do.
Documentation to streamline processes and reduce errors
Good technical documentation (that is comprehensive) goes beyond merely ensuring compliance to make it easier for the manufacturers at any stage of the lifecycle now or in future. It serves as a common touchpoint for all concerned stakeholders – from the development to manufacturing and post-market surveillance of the medical device.
Technical documentation helps streamline workflows and reduce errors as it accurately documents all the relevant processes and procedures as per MDR or IVDR. Manufacturers use it as a road map and reference to verify that all involved follow given procedures consistently covering all the harmonized standards and MDR/IVDR regulations. This process alignment reduces the chance that mistakes will be made, or requirements not met, which improves the quality of the product and patient safety.
Types of Technical Documentation Necessary for CE Marking
For CE marking of medical equipment, a lot of the different kinds of technical documentation should be produced. We can broadly categorize these types of documentation into Product Documentation and Process Documents.
Docs for medical devices
Product documentation consists of all materials related to the medical device (unsurprisingly) Information on the design, intended use and performance of a device or instruction about such.,9. Safety features Key documents in product documentation include the following:
Technical files: These are documents that provide all the details about a medical device including specifications, manufacturing processes, labelling and instructions for the use of your product.
Design and Risk documentation (Inputs, Outputs, Analysis / Management plans & Verification) ·
Clinical evaluation reports – These are systematic literature reviews that assess the safety and performance of a medical device by evaluating clinical data available in scientific literature. The CER must comply with MEDDEV 2.7.1 Rev 4
How the device is labelled and Instructions for Use (IFU): Accurate labelling of a device and IFU are critical if it is to be used safely and effectively. These documents need to include well-written, relevant and accurate information for users.
Documentation process for CE labelling
Process documentation involves the methods by which manufacturers make sure they are in step with regulations to reach CE mark compliance. This involves documenting the steps and systems in areas such as quality management, risk management, post-market surveillance and vigilance.
Quality management system documentation- This typically deals with Quality policies, procedures and records (related to quality) like manuals of quality, SOPs and QA & CA.
Risk management documentation: Manufacturers are required to document the risk management process for their devices, including hazard analysis; risk assessment and the control measures implemented as per ISO 14971
Post-market surveillance documentation: A document that outlines the procedures for monitoring and evaluating performance, safety, and effectiveness data after a device has been released in the market
Vigilance documentation: manufacturers are required to document their procedures for tracking and notifying regulatory bodies of any incidents or complaints related to the device
Technical documentation regulatory requirements
Detail of technical documentation in the MDR 2017/745 / IVDR 2017/746 helps to write down what should be in the technical files and other documentation. Manufacturers are required to maintain technical documentation that provides clear and detailed information which complies with the MDR/IVDR, and they must keep it updated.
How to Write Good Technical Documentation for CE Certification
Developing good documentation for obtaining CE marking certification needs meticulous preparation and support from major players. Below is a structured process one could follow to create & maintain the Technical Documentation:
Define the correct scope, rule and class justification
- Interact with experts from multiple areas including, engineering, quality assurance and regulatory affairs who can provide you with all information to be documented. Our team will work closely with these experts to reduce inaccuracies and increase the comprehensively in our data.
- Use standardised templates for the same type of documents for risk analysis, DOC, usability and GSPR to streamline all types of document creation, review and approval with documentation management
- Review the documentation thoroughly to detect and correct any mistakes, discrepancies or omissions.
- The technical documentation should detail the compliance of a medical device with the essential requirements mentioned in the MDR. This should also include proof of the safety and data, including performance test results and clinical evaluation outcomes to substantiate its claims.
Considerations for Design of Technical Documentation MDR
When CE marking technical documentation is being put together, there are best practices that need to be adhered to for it not only to comply but also effective.
Documentation should be clear, concise and consistent across the board.
Be direct with the information and use plain English in cross-compliance to deliver effectively.
Please, follow a standard document structure and format for readability. Organize logical content with headings, subheadings, & numbering
Documenting evidence that the product conforms and is safe to use
Detailed current information on the design, material of construction, intended use and manufacturing process for said medical device
Safety data, for example, risk assessments or safety testing and clinical evaluation results to support the device’s safety claims as required by MDR compliance.
