Medical Device Technical Documentation for MDRmeans a set of documents demonstrating a specific product’s compliance with the relevant CE marking legislation. The documentation must indicate the applicable product safety standards and requirements and cover the product’s design, manufacture, and operation.
TheTechnical Documentationof a device must be available for inspection by the market surveillance authorities when the product is placed on the EU market, whatever its geographical origin is. In some cases, the technical documentation may also need to be presented to a Notified Body for review.
- AsCE mark consultantsfor medical devices we’ll help you for the process of making a defined technical file with all the product details.
- We will help you in meeting European submission standards that state the product offered is in compliance with the exact requirements of European safety.
Looking Forward To CE Marking Process For Medical Devices ?
We help you in the process of making a defined and comprehensive technical file with all product details required for CE marking.
Contact Us WhatsAppThe manufacturer or their appointed authorized representative must keep theTechnical Documentationfor at least fifteen years from the product’s last date of manufacture.
Medical Device Technical Documentation for MDRis a comprehensive description of your device intended to demonstrate compliance with European requirements. Compiling your technical file or design dossier is a critical step in Europe’s CE Marking process and a requirement for compliance with the Medical Devices Directive, In Vitro Diagnostic Medical Devices Directive 98/79/EC, or Active Implantable Medical Devices Directive 90/385/EEC.
The new Medical Devices Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) will change CE Marking and Technical File requirements for medical devices and IVDs.
Operon Strategist can assist you with the MDR/IVDR transition process.
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Medical Device Technical Documentation for MDR
The technical Documentation or dossier includes detailed information about the design, function, , use, claims, material of construction and clinical evaluation of your medical device.They are required for all classes of devices (Class I, I Measuring, I Sterile, IIa, IIb, and III), but no two files are the same because the type of device dictates the information included therein.Unless you manufacture a Class I device that is not provided sterile and does not have a measuring function, your Technical File must be reviewed by a Notified Body.Understanding how to assemble this information and present it for review by Notified Bodies is essential.
Medical Device Technical Documentation for MDR是一个总结的文档准备的制造商in a clear, well-organized, readily searchable, and unambiguous manner to demonstrate the safety and performance of the device in question.
TheMedical Device Technical Documentation for MDRmust be submitted to Notified Body or Competent Authority for review and approval. It should be preferably made in the English language or in an official language of an EU Member state. It must be available on request for the whole life cycle of the medical device (5 years for low risk and 15 years for high-risk devices). Non-EU manufacturers must keep the file with the authorized representative (AR) in the EU.
MDR Technical Documentation
QA and Regulatory team members are always confused or find it difficult in identifying the required number of medical device technical files for the products planned for European CE Marking.It is advised to remember that medical device technical file or documentation is all about your device to establish safety and performance.It means you cannot combine products with the different intended use, or different class, or different construction material, or even different design.
You need to consider the below parameter while planning to prepare a technical file:
- Device Intended use and Indication of use
- Site of application
- Design change or major constructional changes
- State of the art
Medical Device Technical File
- Requirement & Identification as per CE MDR
- Risk classification and identification of assessment route of CE Marking
- General Safety and performance requirement evaluation.
- Systmatically organize and arrange Files and review.
- Clinical Evaluation documentation covering PMS, PMCF & PSUR
- Risk Analysis
- Medical Device Quality Management System Implementation
One may think that thisMedical Device Technical Documentation for MDRis public but in reality, this document will be reviewed only by medical device experts from the authorities and your Notified Body (TÜV SÜD, BSI… In fact, this is the objective to create a Technical Documentation.In the case of Class I (Self-certified) product, this document is still necessary in case of a review made by your competent authorities. So don’t think that because of self-certification you are not obliged to get it done.
In case of a product higher than pure class I, then there will be a need for a review made by your Notified Body that you must have selected. (This includes class I sterile, with measuring function or reprocessed)
Medical Device Technical Documentation for MDR is a core part of the process of approval of medical devices. Without this documentation, a manufacturer cannot perform the conformity assessment procedure with his medical device, thus, the product cannot be approved. Therefore, it is of great importance to maintain a technical documentation compliant with the standard. The new MDR adds further elements and requirements, which result in a notable extra effort for the technical documentation. Therefore, it is essential not to lose track with so many formalities.