The European Union’s Medical Device Regulation (EU) 2017/745 mandates extensive technical documentation to demonstrate the safety, quality, and performance of medical devices. Manufacturers should prepare and maintain this documentation throughout the entire lifecycle of the device to ensure compliance with the stringent regulatory requirements. It serves as critical evidence of compliance and is essential for CE marking and continued market access.
The essential aspects of technical documentation required under the MDR
- Technical documentation serves as a structured repository of information demonstrating that a medical device meets regulatory, safety, and performance requirements. It allows Notified Bodies, Competent Authorities, and other stakeholders to assess the conformity of a device.
- Technical documentation demonstrates how the device satisfies every applicable General Safety and Performance Requirements (GSPRs) outlined in Annex I of the MDR. The documentation presents evidence of compliance with design, manufacturing, performance, and safety.
- Improved traceability comes through deploying the Unique Device Identification (UDI) system. Using UDI, most of the details about implanted devices are opened up to the benefit of patients in terms of understanding and trust. Besides UDI, another critical aspect of tracking adverse events includes improving understanding of the performance of devices in actual settings to make better and, ultimately, safer devices.
- A well-structured technical documentation guarantees a seamless conformity assessment process with the Notified Body and acts as the primary evidence to prove the device complies with CE marking standards. Regulation 2017/745 mandates manufacturers to carry out post-market surveillance (PMS) that includes PMS plans, PMS Reports (PMSR) or Periodic Safety Update Reports (PSUR), Post-market Clinical Follow-up (PMCF) data, and vigilance systems supporting ongoing compliance.
- During inspections or audits, Notified Body and Regulatory authorities may request access to technical documentation. Comprehensive and organized documentation facilitates efficient review processes.
- Manufacturers cannot apply the CE mark or legally market their devices within the European Union without the technical documentation
Key Components of Technical Documentation under MDR
- Device Description and Specification: It gives a precise overview of the device, including its intended purpose, device’s design, components, materials, operating principles, and key technical specifications. It shall also specify the target patient population, intended clinical indication, medical condition, and any size variations, configurations, or features to accommodate different needs or use cases.
- Instructions for Use (IFU) and Labeling: It should provide clear, accurate, and compliant information designed to guide end users in the safe and effective use of the device. It should include the information required by the applicable sections 23 of Annex I of Regulation (EU) 2017/745, The information must be presented in a manner that is easily understandable to the intended user group, including healthcare professionals or laypersons.
- The Design and Manufacturing Information: These include the design inputs and outputs, design controls, and any design changes made during the design development stage. It specifies the raw materials sources, properties, attributes, and compliance with regulatory standards. It outlines the manufacturing processes in brief as well as via schematic representation, including assembly methods, quality control measures, and traceability procedures, ensuring the device consistently meets safety and performance standards.
- GSPR Checklist: It provides documented evidence of the device’s compliance with the General Safety and Performance Requirements (GSPR) outlined in Annex I of Regulation (EU) 2017/745. This checklist provides a systematic reference to the provisions of each of these requirements in the technical documentation that illustrates conformity.
- Benefit-Risk Analysis and Risk Management: It provides a comprehensive record of the risk management activities carried out for the device, considering the requirements of ISO 14971 and ISO/TR 24971. It includes an identification of risks in the device lifecycle using risk analysis, and assess the severity and likelihood of potential hazards. This also contains the mitigation strategies and controls that bring the risks to acceptable levels, followed by proof of the efficacy of the mitigation strategies and controls.
- Product Verification and Validation: To ensure safety with use of device, Pre-Clinical & Clinical Data which includes engineering, laboratory, simulated use, and animal studies, Biocompatibility (in-vivo and in-vitro studies), chemical/physical properties, electrical safety, software validation, stability (shelf life), and overall performance must be tested.
Clinical Evaluation Report (CER): CER documents the device’s clinical safety and performance through robust clinical data. It analyzes evidence from pre-market investigations, post-market surveillance, scientific literature, and equivalent devices. The report outlines the entire evaluation process, addresses all identified risks, confirms the safety in achieving the device’s intended purpose safely, provides conclusions on its benefit-risk profile, and ensures compliance with Regulation (EU) 2017/745.
Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF): PMS under MDR (EU) 2017/745 mandates manufacturers to continuously monitor device performance and safety after they are put on the market. PMS systems must be proactive, systematic, and documented, ensuring compliance with Annex III. PMCF is a key part of PMS, collecting real-world clinical data to confirm safety, performance, and risk-benefit balance. PMCF studies identify emerging risks, support risk management, and update clinical evaluations. Regular Periodic Safety Update Reports (PSURs) and PMS Reports ensure ongoing regulatory compliance and patient safety.
Summary of Safety and Clinical Performance: SSCP ensures transparency by providing objective and evidence-based information on medical device safety and clinical performance under MDR (EU) 2017/745, Article 32 for class III and implantable devices. The device description, intended use, risk-benefit analysis, clinical evaluation outcomes, and post-market surveillance data are all included in the SSCP. By empowering healthcare professionals and, when appropriate, patients to make informed decisions, it enhances regulatory compliance rather than taking the role of the instructions for use (IFU).
- Conclusion
MDR compliance hinges on robust technical documentation, a non-negotiable requirement for every manufacturer seeking CE marking and continued access to the European market. This documentation plays a crucial role in ensuring that only safe and effective medical devices are available to patients and intended users. Therefore, manufacturers must prioritize investing the necessary time and resources to create comprehensive and compliant technical documentation.
Author
Mrs. Kirti Salunke, (M.Pharm)
Team Lead -Medical Device Consultant