The goal of this publication is to help you in the development of the technical documentation associated to your medical device and in its presentation. The earlier you start with a clear vision of its structure and its presentation for submission, the easier it will be to develop it efficiently without impacting drastically your development activities.
This is the fourth part of a series of 6 articles on this topic. It focuses on the description of the expected content of a technical documentation.
The information gathered in this publication should be particularly useful for:
- Project Managers,
- Quality & Regulatory Managers.
The expected content for the technical documentation is described in the Annex II and III of the MDR (EU 2017/745) and shall include:
- Device description and specification, including variants and accessories,
- Information to be supplied by the manufacturer (labeling and instructions for use),
- Design and manufacturing information,
- General safety and performance requirements,
- Benefit-risk analysis and risk management,
- Product verification and validation,
- Pre-clinical and clinical data,
- Additional information required in specific cases,
- Post-market surveillance plan.
More details about their exact expectations are provided in the next chapters.
Device description and specifications
The following information regarding device description and specifications shall be provided:
- Product or trade name with a general description of the device including its intended purpose and the description of its intended users,
- Product unique identifier or other unambiguous reference allowing traceability and compliant with the UDI system (MDR Annex VI) as soon as this system is in place.
- Description of the intended patient population and medical conditions to be diagnosed, treated and/or monitored and other considerations such as patient selection criteria, indications, contra-indications, and warnings.
- Principles of operation of the device and its mode of action, scientifically demonstrated if necessary.
- The rationale for the qualification of the product as a device.
- The risk class of the device and the justification for the classification rule(s) according to MDR Annex VIII.
- Explanation of any novel features.
- A description of the accessories or other devices and products which are intended to be used in combination with your device.
- A description or complete list of the various configurations/variants of the device that are intended to be made available on the market.
- A general description of its functional elements (e.g., parts and components), composition, functionality and where relevant its qualitative and quantitative composition.
- A description of the raw materials incorporated into key functional elements and making either direct or indirect contact with human body parts.
- Technical specifications, such as features, dimensions and performance attributes of the device and any variants/configuration and accessories
In addition, references to previous and similar generations of your device:
- An overview of the previous generation(s) of the device produced by the manufacturer,
- And/or an overview of identified similar devices available on the European Union or international markets.
Labelling and instructions for use
Your technical documentation shall include:
- A description of the label or labels on the device and on its packaging, such as single unit packaging, sales packaging, transport packaging in case of specific management conditions.
- The instructions for use in the languages accepted in the Member States where the device planned to be sold.
Design and manufacturing information
Your technical documentation shall include:
- Information to allow the design stages applied to the device to be understood,
- Complete information and specifications, including the manufacturing processes and their validation, their adjuvants, the continuous monitoring, and the final product testing. Data shall be fully included in the technical documentation,
- Identification of all sites, including suppliers and sub-contractors, where design and manufacturing activities are performed.
General safety and performance requirements
The documentation shall contain information for the demonstration of conformity with the general safety and performance requirements set out in Annex I of the MDR that are applicable to the device considering its intended purpose, and shall include a justification, validation and verification of the solutions adopted to meet those requirements. The demonstration of conformity shall include:
- The general safety and performance requirements that apply to the device and an explanation as to why others do not apply,
- The method or methods used to demonstrate conformity with each applicable general safety and performance requirement,
- The harmonized standards, Common Specifications (CS) or other solutions applied,
- The precise identity of the controlled documents offering evidence of conformity with each harmonized standard, CS or other method applied to demonstrate conformity with the general safety and performance requirements. The information referred to under this point shall incorporate a cross-reference to the location of such evidence within the full technical documentation and, if applicable, the summary technical documentation.
Benefit-risk analysis and risk management
The documentation shall contain information on:
- The benefit-risk analysis referred to in Sections 1 and 8 of Annex I of the MDR,
- The solutions adopted and the results of the risk management referred to in Section 3 of Annex I of the MDR.
Product verification and validation
The documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of this Regulation and the applicable general safety and performance requirements.
Pre-clinical and clinical data
The documentation shall contain:
- Results of tests, such as engineering, laboratory, simulated use and animal tests, and evaluation of published literature applicable to the device, considering its intended purpose, or to similar devices, regarding the pre-clinical safety of the device and its conformity with the specifications,
- Detailed information regarding test design, complete test or study protocols, methods of data analysis, in addition to data summaries and test conclusions regarding in particular:
- The biocompatibility of the device including the identification of all materials in direct or indirect contact with the patient or user,
- Physical, chemical, and microbiological characterization,
- Electrical safety and electromagnetic compatibility,
- Software verification and validation (describing the software design and development process and evidence of the validation of the software, as used in the finished device. This information shall typically include the summary results of all verification, validation and testing performed both in-house and in a simulated or actual user environment prior to final release. It shall also address all the different hardware configurations and, where applicable, operating systems identified in the information supplied by the manufacturer),
- Stability, including shelf life.
- Performance and safety. Where applicable, conformity with the provisions of Directive 2004/10/EC of the European Parliament and of the Council ( 1 ) shall be demonstrated. Where no new testing has been undertaken, the documentation shall incorporate a rationale for that decision. An example of such a rationale would be that biocompatibility testing on identical materials was conducted when those materials were incorporated in a previous version of the device that has been legally placed on the market or put into service,
- The clinical evaluation report and its updates and the clinical evaluation plan referred to in Article 61(12) and Part A of Annex XIV of the MDR,
- The PMCF (Post Market Clinical Follow-up) plan and PMCF evaluation report referred to in Part B of Annex XIV of the MDR or a justification why a PMCF is not applicable.
Additional information required in specific cases
In the following specific cases, the technical documentation shall additional information:
- Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product, including a medicinal product derived from human blood or human plasma.
- Where a device is manufactured utilizing tissues or cells of human or animal origin, or their derivatives.
- In the case of devices that are composed of substances or combinations of substances that are intended to be introduced into the human body and that are absorbed by or locally dispersed in the human body.
- In the case of devices containing CMR or endocrine-disrupting substances.
- In the case of devices placed on the market in a sterile or defined microbiological condition.
- In the case of devices placed on the market with a measuring function.
- If the device is to be connected to other device(s) to operate as intended.
Post-market surveillance plan
The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles 83 to 86 of the MDR shall be presented in a clear, organized, readily searchable and unambiguous manner.
- The post-market surveillance plan shall address the collection and utilization of available information, in particular: information concerning serious incidents, including information from PSURs, and field safety corrective actions; records referring to non-serious incidents and data on any undesirable side-effects; information from trend reporting; relevant specialist or technical literature, databases and/or registers; information, including feedbacks and complaints, provided by users, distributors and importers; and publicly available information about similar medical devices.
The post-market surveillance plan shall cover at least: a proactive and systematic process to collect any information referred to in previous point. The process shall allow a correct characterization of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market; effective and appropriate methods and processes to assess the collected data; suitable indicators and threshold values that shall be used in the continuous reassessment of the benefitrisk analysis and of the risk management; effective and appropriate methods and tools to investigate complaints and analyses market-related experience collected in the field; methods and protocols to manage the events subject to the trend report, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period; methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users; reference to procedures to fulfil the manufacturers obligations laid down in Articles 83, 84 and 86; systematic procedures to identify and initiate appropriate measures including corrective actions; effective tools to trace and identify devices for which corrective actions might be necessary; and a PMCF plan as referred to in Part B of Annex XIV of MDR, or a justification as to why a PMCF is not applicable.
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