What is MDR Technical Documentation for Medical Devices?
Medical Device Technical Documentation for MDR refers to a set of documents that demonstrate a specific medical device’s compliance with relevant CE marking legislation. It includes information on the product’s design, manufacture, and operation, as well as the applicable safety standards and requirements.
Purpose of MDR Technical Documentation for Medical Devices?
The purpose of the technical documentation is to establish the device’s compliance with European requirements and demonstrate its safety and performance. It is a critical step in the CE marking process and a requirement for compliance with the Medical Devices Directive, In Vitro Diagnostic Medical Devices Directive, or Active Implantable Medical Devices Directive.
What are the Regulatory Changes?
The EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have introduced changes to CE marking and Technical File requirements for medical devices and in vitro diagnostics.
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Components of Medical Device Technical Documentation for MDR:
What Does it Include?
The technical documentation encompasses detailed information about the medical device, including its design, function, claims, materials, and clinical evaluation. The specific content of the documentation varies depending on the device’s classification.
Is Notified Body Involvement Necessary?
Unless the device is a Class I device that is not sterile and does not have a measuring function, the Technical File must be reviewed by a Notified Body. Understanding how to assemble and present the information for review is crucial.
Submission and Maintenance of Medical Device Technical Documentation for MDR:
Who Reviews the Documentation?
The Technical Documentation is reviewed by Notified Bodies or Competent Authorities. It is prepared by the manufacturer in a clear, well-organized, and unambiguous manner to demonstrate the device’s safety and performance.
The documentation should preferably be in English or an official language of an EU Member State.
How Long Should it be Maintained?
The manufacturer or their appointed authorized representative must keep the Technical Documentation for at least fifteen years from the product’s last date of manufacture. Non-EU manufacturers must keep the file with their authorized representative in the EU.
Importance and Considerations for MDR Technical Documentation
Why is it important?
The MDR Technical Documentation is a core part of the medical device approval process. Without it, a manufacturer cannot perform the conformity assessment procedure or gain product approval.
Are there specific considerations?
Various factors need to be considered when preparing the technical file, such as the device’s intended use, indication of use, site of application, design changes, risk classification, safety and performance requirements, clinical evaluation, risk analysis, and implementation of a quality management system.
In conclusion, Medical Device Technical Documentation for MDR is a crucial collection of documents that demonstrate a medical device’s compliance with European requirements. It is reviewed by authorities and Notified Bodies, and its proper preparation and maintenance are essential for CE marking and product approval.
Are you in need of assistance with Medical Device Technical Documentation for MDR? Our team of experienced regulatory consultants at Operon Strategist can guide you through the process. Contact us now to ensure compliance and a successful CE mark for your medical device.
