Table of Contents
The essential Technical File checklist for medical device manufacturers. Download the one-page guide to make sure you’ve got everything you need to achieve MDR compliance and get a CE mark.
If you are a medical device manufacturer and are intending to sell your product in the European Market, than you are required to establish conformity according to the European Union Medical Device Regulation 2017/745 ANNEX IX to XI (EU MDR 2017/745)1. You can establish this conformity by compiling documentation, known as a Technical File, to seek approval for selling your medical devices.
Download the Medical Device Technical File Checklist
According to the MDR, the technical file is a mandatory document for all types of medical devices that has to be prepared in a clear understandable language and must be well-organized and readily-searchable. It is essential to demonstrate the safety and performance of a specific device.The Technical File acts as a documented evidence to demonstrate that a product is safe for its intended use and effectively fulfills the required purpose.
The EU MDR 2017/745 explains and defines the requirements for the medical device (Annex I)2 and it also defines the requirements for the Technical File documentation (Annex II)3. You can pass this conformity assessment and attain approval for a medical device very easily by meeting the requirements for your TECHNICAL FILE. Essentially your file must contain the following elements.
Device description & specifications
The purpose is to fully understand the product, its purpose, specifications, constituents and materials. In this document you must explain your product completely along with system of assigning the basic UDI-DI, description of your product’s classification from rules in Annex VIII and how under Article 51.
- Specifications include product name or trade name along with the basic UDI-DI or any clear identification.
- Device Description is the general description, principle of operation, technical specifications, description of any accessories or variants, key functional elements/parts/components/software and composition.
Information to be supplied by the manufacturer
- INSTRUCTION FOR USE (IFU) – This document must contain your device’s description & specification, purpose and any warnings and precautions. Purpose of the device is the key element in the IFU. It states the intended users along with intended patient, conditions to be diagnosed/treated/monitored, indications, contraindications, warnings, precautions and hazards.
- PACKAGING & LABELLING INFORMATION – Under the MDR, in this document you must explain the complete labeling and packaging information. It should also include any description relating to single-unit sales; transport packaging in case of specific management conditions and it must contain symbols for all hazards, warning, handling instructions, date of manufacture and expiry.
NOTE: It is very important that this information must be publicly available documents and must be in one of the official languages of the EU and in the language required by the Member State.
Design & manufacturing information
In this document you must outline and explain;
- Design schematics, drawings &materials utilized.
- Processes of manufacture
- Data about all sites, where design and manufacturing activities are performed. All other subcontracted steps or processes involved in the production in any way (such as sterilization, production of a particular part or accessory, or packaging) should be explained along with the full information about name and address, as well as a description of which part of the process they perform
- Quality control procedures & checks
This document is prepared in correlation with ISO 13485 and contains information from procedures, research plans, protocols, results of verification and validation, production process in detail.
General safety & performance requirements
This document, also called as GSPR, is mandated under Annex 1 of the MDR. It is required to provide evidence for design and production in accordance with all applicable requirements. This is compulsory to ensure its safe use and effectiveness. This document was previously known as the essential requirements checklist.
Verification & validation information
- VERIFICATION & VALIDATION REPORT – Here you must explain and show documentation of Biocompatibility testing, Safety regarding chemical components, Electricity safety, Stability when stored under prescribed conditions, Sterility and Usability. The results of these test and analysis of this pre-clinical data is compiled in this report. Besides pre-clinical data, it is important to get clinical data, which can be obtained by clinical evaluation or clinical investigation. The European Commission’s main emphasis is on clinical data – not just during design and development, but post-market, too.
- CLINICAL EVALUATION REPORTS (CER) – This report should provide a comprehensive overview of the device’s design and composition, as well its intended applications. This document must elaborate the State-of-the-Art, clinical, biological and technical comparison to a device similar to the Device. Where there are similar devices present compilation of published clinical data and any relevant literature reviews is done. However, if the device is novel than the manufacturer is required to perform Clinical Studies to establish the Technical, Clinical and Biological safety and efficacy.
- BIOLOGICAL EVALUATION REPORT (BER) – This is a compilation of biocompatibility of each material that comes into contact with intact skin or tissue of the human body. This report is compiled in accordance with ISO 10993-1 Biocompatibility standards.
- HS COMPLIANCE MATRIX to ISO 10993-1:20214 – This document is prepared as a checklist to establish the applicable requirements under this biocompatibility standard. It also establishes the biocompatibility tests applicable on the device under ISO 10993
- Post-Market Clinical Follow-Up (PMCF) –You are required to maintain a process to continuously update the clinical evaluation and necessitates the proactive gathering of clinical data and its evaluation,after sale of your device(outlined in Part 2 of Annex XIV)5. These steps allow you to confirm the safety and performance throughout the expected lifetime of your device. This also ensures the acceptability of already identified risks and to detect emerging risks based on factual evidence.
- Post-Market Surveillance (PMS) plan and report–The MDR requires that you as a manufacturer must maintain a compilation of clinical and safety-related data after the approval/CE certification process and market access. This allows you and your Notified Body to systematically identify risks in the practical use of the product, as some risks only become apparent when your medical devices are used, stored, transported or cleaned. It is a beneficial step, as it enables you to ensure that your devices are safe and that there are no uncontrolled risks such as defects or undetected security problems.
The process of identification, understanding, controlling, and prevention of failures that can result in hazards from the use of your device, is called Risk Assessment. Article 10/2 of the Regulation requires that you must establish, document, implement and maintain a product safety risk management system throughout the lifecycle of your medical device. The detailed requirements of the system are listed in the Annex I Chapter I, points 2-9.The MDR is in alignment with EN ISO 14971:2012 and EN ISO 13485:20166. The building of a Risk Analysis Plan & Report, in accordance with these two ISO standards, allows you to comply with the MDR and establish the Risk-Benefit analysis.
- RISK MANAGEMENT PLAN
- RISK MANAGEMENT REPORT
Declaration of Conformity
This is a mandatory document for you and an important step towards your conformity assessment. According to MDR Article 19,manufacturer or authorized representative sign, to declare that the products comply with the EU requirements including all applicable legislations and ISO harmonized standards. It contains the following information:
- name and full business address or that of authorized representative
- the product’s serial number, model or type identification
- classification of the Medical Device under the MDR Annex VIII7/8
- a statement, stating full responsibility
- identification of product allowing traceability – this can include an image
- details of the notified body which carried out the conformity assessment procedure (if applicable)
- relevant legislation with which the product complies, as well as any harmonised standards or other means used to prove compliance
- name and signature
- date the declaration was issued
- supplementary information (if applicable)
Thus in conclusion, you as a manufacturer must have and maintain an up-to-date Technical File, regardless of a device class, or its intended use, design, or even the safety history. These discussed essential elements that constitute the key factors of a Technical File are your easiest way towards establishing and demonstrating compliance with EU MDR 2017/745.
Need help with your technical documentation and MDR compliance? Consult medical device CER writers, medical device regulatory experts, and MDR consultants on Kolabtree.
- European Union Medical Device Regulation 2017/745 [https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745]
- ANNEX I – General safety and performance requirements [https://www.medical-device-regulation.eu/2019/07/23/annex-i-general-safety-and-performance-requirements/]
- EN ISO 10993-1:2021 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- ANNEX XIV Clinical evaluation and post-market clinical follow-up [https://www.medical-device-regulation.eu/2019/08/14/annex-xiv/]
- ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes [https://www.iso.org/standard/59752.html]
- MDCG 2021-24 Guidance on classification of medical devices [https://ec.europa.eu/health/system/files/2021-10/mdcg_2021-24_en_0.pdf]
- EU MDR Annex VIII [https://www.medical-device-regulation.eu/2019/08/08/annex-viii/