Medical Device Technical File

At Iqzyme, we specialize in compiling and organizing the comprehensive MDR Technical Documentation required for CE Marking under the EU Medical Device Regulation (EU MDR 2017/745). Our team of experts is proficient in all core areas necessary for successful regulatory submissions, ensuring your technical documentation meets the highest standards of safety, performance, and compliance.

The Regulation (EU) 2017/745, Annex II, mandates that the medical device technical file be a comprehensive, well-organized, and readily searchable document prepared by the manufacturer. This file must clearly and unambiguously demonstrate the safety and performance of the device. The content of the technical documentation should be determined based on the device’s construction and intended use. Manufacturers are required to submit the medical device technical documentation to a Notified Body or competent authority for review and approval. The documentation should preferably be in English or another official language of an EU Member State. It must be maintained and available upon request throughout the entire lifecycle of the medical device, which is five years for low-risk devices and 16 years for high-risk devices. Non-EU manufacturers must ensure that this documentation is held by their European Authorized Representative.

Regardless of the medical device's classification, intended use, construction, or safety history, the manufacturer is obligated to maintain and regularly update the technical file to demonstrate compliance with the General Safety and Performance Requirements (GSPR) outlined in Annex I of Regulation (EU) 2017/745. The regulation specifies the essential elements that must be included in the technical documentation, ensuring comprehensive compliance with regulatory standards. For more detailed information, refer to the following sections.

MDR Technical File Selection Criteria

Selecting the appropriate technical file is crucial for regulatory compliance and product safety. Quality Assurance and Regulatory teams often struggle to determine the correct number of technical files needed for CE Marking. When compiling MDR documentation, it is essential to focus on a specific device to demonstrate safety and performance. Products with different intended uses, classifications, materials, or designs must have separate technical files.

Intended Use and Indication for Use: Each technical file must be specific to devices that share the same intended use and indication for use. Devices with different intended applications must be documented separately.

Site of Application: Devices intended for different anatomical sites or types of application should not be combined in the same technical file.

Design or Major Constructional Changes: Any device that has undergone significant design or construction changes must have its technical file to reflect these modifications and their impact on safety and performance.

State of the Art: The technical file should reflect the current state of the art, incorporating up-to-date standards and technological advancements relevant to the device.

EMDN/GMDN Code: Devices classified under different European Medical Device Nomenclature (EMDN) or Global Medical Device Nomenclature (GMDN) codes should have separate technical files, as these codes reflect distinctions in device categories that may affect regulatory requirements.

Medical Device Technical File Consultants

Requirement & Identification: Ensuring compliance with CE Medical Device Regulation through precise requirement identification.

Risk Classification: Accurate risk classification and identification of the appropriate assessment route for CE Marking.

File Organization: Systematic organization and thorough review of technical documentation.

Clinical Evaluation Documentation: Complete support for PMS, PMCF, and PSUR documentation.

Risk Analysis: In-depth risk analysis to meet regulatory standards.

Quality Management System Implementation: Assistance with the implementation and maintenance of a Medical Device Quality Management System.

For more details on how we can help you achieve CE Marking and regulatory compliance, contact us today.

EU MDR Technical Documentation Types

Class I – Active Device, Non-Sterile with/without Software

Class I – Non-Active Device, Non-Sterile

Class I – Non-Active Device, Sterile / Measuring / Reusable

Class I – Active Device, Sterile / Measuring / Reusable

Class I – Software Device with or without Measuring Function

Class IIa – Active Device, Sterile / Non-Sterile / Measuring / Reusable /with/without Software

Class IIa – Non-Active Device, Sterile / Non-Sterile / Measuring / Reusable

Class IIa – Non-Active Device, Implant Sterile / Non-Sterile / Measuring / Reusable

Class IIa – Software Device, with or without Measuring Function

Class IIb – Active Device, Sterile / Non-Sterile / Measuring / Reusable with/without Software

Class IIb – Non-Active Device, Sterile / Non-Sterile / Measuring / Reusable

Class IIb – Non-Active Device, Implant Sterile / Nonsterile / Measuring / Reusable

Class IIb – Software Device, with or without Measuring Function

Class III – Active Device, Sterile / Non-Sterile / Measuring / Reusable with/without Software

Class III – Non-Active Device, Sterile / Non-Sterile / Measuring / Reusable

Class III – Non-Active Device, Implant Sterile / Non-Sterile / Measuring / Reusable

Class III – Active Device, Implant Sterile / Non-Sterile / Measuring / Reusable / with or without Software

Class III – Software Device, with or without Measuring Function

Special Rule – Class III – Devices incorporate medicinal products under Rule 14

Special Rule – Class IIa/IIb – Devices for contraception under rule 15

Special Rule – Class IIa/IIb – Devices used for disinfecting, cleaning or sterilising medical devices under rule 16

Special Rule – Class III – Devices made using tissues or cells of human or animal origin, or their derivatives under rule 18

Special Rule – Class IIa/IIb/III – Nano-materials under rule 19

Special Rule – Cass IIa/IIb – Devices for medicinal inhalation under rule 20

Special Rule – Class IIa, Class IIb and Class III – Devices composed of substances that absorbed or locally dispersed under rule 21

QMS Procedures Linked with Technical Documentation

Quality Management System (QMS) procedures aligned with the EU Medical Device Regulation (MDR 2017/745) are essential for ensuring that the technical documentation meets all regulatory requirements. These procedures are integral to maintaining compliance and securing CE Marking for your medical devices. Key QMS procedures include:

Procedure for Device Classification: Ensures accurate classification of medical devices according to MDR risk categories.

CE Marking Procedure: Outlines the steps for obtaining CE Marking, demonstrating conformity with the MDR.

Labelling Procedure: Establishes guidelines for compliant labelling, including symbols, language requirements, and content as per MDR.

Vigilance Procedure: Defines the process for monitoring and reporting adverse events, ensuring ongoing compliance with MDR vigilance requirements.

Significant Change Notification Procedure: Details the procedure for notifying regulatory authorities of significant changes to the device that may impact its safety and performance.

PRRC Appointment: Procedure for appointing the Person Responsible for Regulatory Compliance (PRRC) as mandated by the MDR.

Language Translation: Ensures that all technical documentation and labelling are accurately translated into the official languages of the EU Member States where the device will be marketed.

Advisory Notice: Outlines the process for issuing advisory notices to users and authorities in case of safety concerns or recalls.

FAQ Section