Medical Device Technical File – Medral Global
At Medral Global, we specialize in compiling and organizing comprehensive MDR Technical Documentation necessary for CE Marking under the EU Medical Device Regulation (EU MDR 2017/745). Our expert team ensures your technical file meets stringent safety, performance, and compliance standards for successful regulatory submissions.
Regulatory Requirements
According to Regulation (EU) 2017/745, Annex II, the medical device technical file must be comprehensive, well-organized, and readily searchable. It should be prepared by the manufacturer to clearly demonstrate device safety and performance, be specific to the device’s construction and intended use, submitted to a Notified Body or competent authority for approval, and maintained and available throughout the device lifecycle (5 years for low-risk devices, 16 years for high-risk devices). Non-EU manufacturers must ensure this documentation is held by their European Authorized Representative.
The manufacturer must regularly update the technical file to demonstrate compliance with the General Safety and Performance Requirements (GSPR) outlined in Annex I of the MDR.
MDR Technical File Selection Criteria
Separate technical files are required for devices differing in intended use and indication for use, site of application (anatomical location or application type), design or major construction changes impacting safety/performance, state of the art reflecting current standards and technologies, and EMDN/GMDN codes representing different device categories. Each file should demonstrate safety and performance for the specific device variant.
Medical Device Technical File Consulting Services
We offer expert support in requirement identification for CE MDR compliance, accurate risk classification and assessment route selection, systematic file organization and documentation review, clinical evaluation support including PMS, PMCF, PSUR, detailed risk analysis aligned with regulatory standards, and Quality Management System (QMS) implementation and maintenance.
Contact us for detailed guidance on achieving CE Marking and regulatory compliance.
EU MDR Technical Documentation Types by Device Class
Class I devices include active/non-active, sterile/non-sterile, with or without software, measuring and reusable variants. Class IIa devices include active/non-active, sterile/non-sterile, implant, measuring/reusable, and software variants. Class IIb and Class III follow similarly with active/non-active, sterile/non-sterile, implant, measuring/reusable, and software variants.
Special MDR Rules for Specific Devices
Special rules apply to Class III devices incorporating medicinal products (Rule 14), Class IIa/IIb devices for contraception (Rule 15), devices for disinfecting/cleaning/sterilizing (Rule 16), devices made using tissues or cells of human or animal origin (Rule 18), devices containing nano-materials (Rule 19), devices for medicinal inhalation (Rule 20), and devices composed of substances that are absorbed or locally dispersed (Rule 21).
Quality Management System (QMS) Procedures Linked to Technical Documentation
Key QMS procedures essential for MDR compliance and CE Marking include device classification, CE marking, labelling (symbols, language, content), vigilance (adverse event monitoring/reporting), significant change notification, PRRC appointment, language translation of documentation and labelling, and advisory notice procedures for safety concerns or recalls.