Regulation 2017-745 Annex I Chapter III
Requirements concerning the information provided with the product
| Section | Comments |
|---|---|
| 23.1. General requirements regarding the information supplied by the manufacturer | |
| (a) The medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s). In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams. | As it is a software (SW), it does not generate a physical label like those required for physical medical products. However, the relative information that would be available on the label is hosted on the homepage of ONCOhabitats (https://www.oncohabitats.upv.es), available in both Spanish and English, to facilitate its comprehension. Similarly, on this same homepage, a link has been added to the ONCOhabitats instructions for use, described in both Spanish (instrucciones de uso) and English (instructions for use) and in a language adapted so that it can be understood by researchers and doctors who wish to use it. |
| (b) The information required on the label shall be provided on the device itself. If this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit, and/or on the packaging of multiple devices. | Relevant information on the medical device that should be on a label if it were a physical product is available on the main tab of the ONCOhabitats website (https://www.oncohabitats.upv.es). |
| (c) Labels shall be provided in a human-readable format and may be supplemented by machine-readable information, such as radio-frequency identification (‘RFID’) or bar codes. | Not applicable as there is no physical label, but the information provided on the page main page of the website (https://www.oncohabitats.upv.es) is of an appropriate size and colour to be easily read. |
| (d) Instructions for use shall be provided together with devices. By way of exception, instructions for use shall not be required for class I and class IIa devices if such devices can be used safely without any such instructions and unless otherwise provided for elsewhere in this Section. | In the main tab of the web page (https://www.oncohabitats.upv.es) a link to the instructions for use is added, both in Spanish (instrucciones de uso) and English (instructions for use), to facilitate the use by potential users. |
| (e) Where multiple devices are supplied to a single user and/or location, a single copy of the instructions for use may be provided if so agreed by the purchaser who in any case may request further copies to be provided free of charge. | The instructions for use are linked from the main page of the software (https://www.oncohabitats.upv.es) and can be reviewed by users as many times as they wish, both in Spanish (instrucciones de uso) and English (instructions for use). |
| (f) Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing rules adopted pursuant to this Regulation. | The instructions for use, both in Spanish (instrucciones de uso) and English (instructions for use), are hosted only on in digital form (non-paper format), and are linked from the ONCOhabitats website. |
| (g) Residual risks which are required to be communicated to the user and/or other person shall be included as limitations, contra-indications, precautions or warnings in the information supplied by the manufacturer. | In section "0 Introduction and background information" of the instructions for use, described both in Spanish (instrucciones de uso) and English (instructions for use), it is detailed that there are a number of specific residual risks associated with ONCOhabitats that are due to the fact that this software has been developed based on data science, Artificial Intelligence (AI) and Deep Learning (DL), so its results should be taken as a decision support, but never as a substitute. |
| (h) Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognised symbols. Any symbol or identification colour used shall conform to the harmonised standards or CS. In areas for which no harmonised standards or CS exist, the symbols and colours shall be described in the documentation supplied with the device. | It does not apply to ONCOhabitats as it does not correspond to an area where there are symbols to represent it. |
| 23.2. Information on the label | |
| (a) the name or trade name of the device; | The name of the software (SW), ONCOhabitats, is indicated on the main tab of the website web (https://www.oncohabitats.upv.es) , which is the only way to access the SW, as well as the patents. |
| (b) the details strictly necessary for a user to identify the device, the contents of the packaging and, where it is not obvious for the user, the intended purpose of the device; | The main tab of the SW website (https://www.oncohabitats.upv.es) details that the product is a medical device under investigation, its name and intended purpose. |
| (c) the name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business; | The name of the SW, the patents and the tax domiciliation are detailed both in the main tab of the software and in the instructions for use. |
| (d)if the manufacturer has its registered place of business outside the Union, the name of the authorised representative and address of the registered place of business of the authorised representative; | Not applicable, as the manufacturer is located within the European Union. |
| (e) where applicable, an indication that the device contains or incorporates: — a medicinal substance, including a human blood or plasma derivative, or — tissues or cells, or their derivatives, of human origin, or — tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012; |
Not applicable, as the product does not contain or incorporate any of the substances listed in these sections. |
| (f) where applicable, information labelled in accordance with Section 10.4.5.; | Not applicable, as the product does not contain or incorporate any of the substances listed in these sections. |
| (g) the lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL NUMBER or an equivalent symbol, as appropriate; | Not applicable, as it is server-hosted software and therefore has no associated batch or serial number. However, each case processed through the ONCOhabitats SW will be identified with a unique code that is registered in the system. |
| (h) the UDI carrier referred to in Article 27(4) and Part C of Annex VII; | Not applicable, as the product is a SW device that is hosted on a server, so there is no physical element or physical support or packaging associated with it. |
| (i) an unambiguous indication of t the time limit for using or implanting the device safely, expressed at least in terms of year and month, where this is relevant; | As it is a medical device under clinical research, its time of use is fixed by this validation and it subsequently becomes a SW for academic use. |
| (j) where there is no indication of the date until when it may be used safely, the date of manufacture. This date of manufacture may be included as part of the lot number or serial number, provided the date is clearly identifiable; | As it is a medical device under clinical research, its time of use is fixed by this validation and it subsequently becomes a SW for academic use. |
| (k) an indication of any special storage and/or handling condition that applies; | The SW is hosted on a secure server at the Universitat Politècnica de València, under secure protocols and following the premises of the data protection delegate of the University. |
| (l) if the device is supplied sterile, an indication of its sterile state and the sterilisation method; | Not applicable, as the product is a SW hosted on a server, is not related to any sterile product or item, and is not supplied sterile. |
| (m) warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device, and to any other person. This information may be kept to a minimum in which case more detailed information shall appear in the instructions for use, taking into account the intended users; | Both on the main screen of the SW website and in the instructions for use, described both in Spanish (instrucciones de uso) and English (instructions for use), it is emphasised that it is a medical device previously evaluated in a multicentre study (NCT03439332) and that it is currently being validated by a clinical investigation with a medical device in the framework of two projects, ALBATROSS (PID2019-104978RB-I00) and SINUE (INNEST/2022/87). |
| (n) if the device is intended for single use, an indication of that fact. A manufacturer's indication of single use shall be consistent across the Union; | Not applicable because it is not a single-use product. |
| (o) if the device is a single-use device that has been reprocessed, an indication of that fact, the number of reprocessing cycles already performed, and any limitation as regards the number of reprocessing cycles; | Not applicable because it is not a single-use product. |
| (p) if the device is custom-made, the words ‘custom-made device’; | Not applicable, as this is not a custom-made product. |
| (q) an indication that the device is a medical device. If the device is intended for clinical investigation only, the words ‘exclusively for clinical investigation’; | Both on the main tab of the website (https://www.oncohabitats.upv.es) and in the instructions for use, described both in Spanish (instrucciones de uso) and English (instructions for use), it is detailed that it is a SW for academic and clinical research use only, but as it is not exclusive, the phrase "exclusively for clinical research" is not detailed. |
| (r) in the case of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body, the overall qualitative composition of the device and quantitative information on the main constituent or constituents responsible for achieving the principal intended action; | Not applicable. Not intended for introduction into the human body, application to the skin or any of the characteristics listed. |
| (s) for active implantable devices, the serial number, and for other implantable devices, the serial number or the lot number. | Not applicable, as it is not an implantable product. |
| 23.3. Information on the packaging which maintains the sterile condition of a device (‘sterile packaging’) | Not applicable, as the product is a SW hosted on a server, is not related to any sterile product or item, and is not supplied sterile. |
| 23.4. Information in the instructions for use | |
| (a) the particulars referred to in points (a), (c), (e), (f), (k), (l), (n) and (r) of Section 23.2; | The information concerning the sections listed in this point corresponding to section 23.2 has been completed on the instructions, described both in Spanish (instrucciones de uso) and English (instructions for use). |
| (b) the device's intended purpose with a clear specification of indications, contra-indications, the patient target group or groups, and of the intended users, as appropriate; | Page 4, point "0 Introduction and background information" of the instructions for use, described both in Spanish (instrucciones de uso) and English (instructions for use), explicitly details the intended purpose of the medical device, the indications for the SW, being that the patient has a diagnosis of high-grade gliomas and the intended users, which are physicians and researchers who have a need or interest in the study of high-grade gliomas, bearing in mind that this is a medical device for academic use. |
| (c) where applicable, a specification of the clinical benefits to be expected. | On page 4, point "0 Introduction and background information" of the instructions for use, described both in Spanish (instrucciones de uso) and English (instructions for use), it is specified that, for the use of SW in a clinical investigation with medical device, the clinical benefits are a better understanding of the anatomy and physiology of the tumour and thus a support for clinicians in planning surgery for high-grade gliomas. |
| (d) where applicable, links to the summary of safety and clinical performance referred to in Article 32; | Not applicable, as the product is an SW classified as type IIa and is not an implantable product. |
| (e) the performance characteristics of the device; | In the instructions for use, described both in Spanish (instrucciones de uso) and English (instructions for use), the operating characteristics of the product are detailed, explaining how it works at user level and the results it generates. |
| (f) where applicable, information allowing the healthcare professional to verify if the device is suitable and select the corresponding software and accessories; | In the case of ONCOhabitats, as the software is hosted on a server and accessed via a web page, it is not necessary to check the suitability of the medical device. However, it must be borne in mind that the sequences requested by the SW must be uploaded correctly. This information is detailed in points 8.4.3 and 8.3.3 of the instructions for use, described both in Spanish (instrucciones de uso) and English (instructions for use). |
| (g) any residual risks, contra-indications and any undesirable side-effects, including information to be conveyed to the patient in this regard; | Not applicable, as there are no residual risks, contraindications or undesirable side effects associated with the product or involved in its performance. |
| (h) specifications the user requires to use the device appropriately, e.g. if the device has a measuring function, the degree of accuracy claimed for it; | The scientific article is cited in the instructions for use (Del Mar Álvarez-Torres et al., 2020) demonstrating the correct functionality of the software. |
| (i) details of any preparatory treatment or handling of the device before it is ready for use or during its use, such as sterilisation, final assembly, calibration, etc., including the levels of disinfection required to ensure patient safety and all available methods for achieving those levels of disinfection; | Not applicable, as the product is a SW hosted on a server, so no sterilisation, final assembly or any of the other processes mentioned in the section are associated with it. | (j) any requirements for special facilities, or special training, or particular qualifications of the device user and/or other persons; | There is no applicable requirement. However, information is added on the website about the course that is held prior to clinical research with an ONCOhabitats-associated medical device. |
| (k) the information needed to verify whether the device is properly installed and is ready to perform safely and as intended by the manufacturer, together with, where relevant: details of the nature, and frequency, of preventive and regular maintenance, and of any preparatory cleaning or disinfection — identification of any consumable components and how to replace them, — information on any necessary calibration to ensure that the device operates properly and safely during its intended lifetime, and — methods for eliminating the risks encountered by persons involved in installing, calibrating or servicing devices; |
Not applicable. The product is a SW hosted on a web server so the user accesses it from a web page and it does not have any type of requirement associated with it for its correct operation, so there is no need for the user to make any checks. |
| (l) if the device is supplied sterile, instructions in the event of the sterile packaging being damaged or unintentionally opened before use; | Not applicable, as it is not a physical product. |
| (m) if the device is supplied non-sterile with the intention that it is sterilised before use, the appropriate instructions for sterilisation; | Not applicable, as it is not a physical product. | (n) if the device is reusable, information on the appropriate processes for allowing reuse, including cleaning, disinfection, packaging and, where appropriate, the validated method of re-sterilisation appropriate to the Member State or Member States in which the device has been placed on the market. Information shall be provided to identify when the device should no longer be reused, e.g. signs of material degradation or the maximum number of allowable reuses; | Not applicable, as the product is a SW hosted on a web server, so no reuse process is associated with it. |
| (o) an indication, if appropriate, that a device can be reused only if it is reconditioned under the responsibility of the manufacturer to comply with the general safety and performance requirements; | Not applicable, as the product is a SW hosted on a web server, so no reuse process is associated with it. |
| (p) if the device bears an indication that it is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. This information shall be based on a specific section of the manufacturer's risk management documentation, where such characteristics and technical factors shall be addressed in detail. If in accordance with point (d) of Section 23.1. no instructions for use are required, this information shall be made available to the user upon request; | Not applicable, as the product is a SW hosted on a web server and does not carry any associated process indicated in this section. |
| (q) for devices intended for use together with other devices and/or general purpose equipment: — information to identify such devices or equipment, in order to obtain a safe combination, and/or — information on any known restrictions to combinations of devices and equipment; |
Not applicable, as the product is a SW hosted on a web server and does not carry any associated process indicated in this section. |
| (r) if the device emits radiation for medical purposes: — detailed information as to the nature, type and where appropriate, the intensity and distribution of the emitted radiation, — the means of protecting the patient, user, or other person from unintended radiation during use of the device; |
Not applicable, as the product is a SW that does not emit radiation. |
| (s) information that allows the user and/or patient to be informed of any warnings, precautions, contra- indications, measures to be taken and limitations of use regarding the device. That information shall, where relevant, allow the user to brief the patient about any warnings, precautions, contra-indications, measures to be taken and limitations of use regarding the device. The information shall cover, where appropriate: — warnings, precautions and/or measures to be taken in the event of malfunction of the device or changes in its performance that may affect safety, — warnings, precautions and/or measures to be taken as regards the exposure to reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, or temperature, — warnings, precautions and/or measures to be taken as regards the risks of interference posed by the reasonably foreseeable presence of the device during specific diagnostic investigations, evaluations, or therapeutic treatment or other procedures such as electromagnetic interference emitted by the device affecting other equipment, — if the device is intended to administer medicinal products, tissues or cells of human or animal origin, or their derivatives, or biological substances, any limitations or incompatibility in the choice of substances to be delivered, — warnings, precautions and/or limitations related to the medicinal substance or biological material that is incorporated into the device as an integral part of the device; and — precautions related to materials incorporated into the device that contain or consist of CMR substances or endocrine-disrupting substances, or that could result in sensitisation or an allergic reaction by the patient or user; |
Not applicable, as there are no contraindications associated with the product. However, it must be taken into account that this is a SW based on Deep Learning, so this fact must be taken into account when interpreting the results. In addition, the instructions for use of the product indicate that if the user detects any failure or malfunction, he/she should notify the Biomedical Data Laboratory (BDSLab) group of the Universitat Politécnica de València (UPV), using the means of contact available on the website of the same. This information is available in point "0 Introduction and background information", page 4 of the instructions for use, described both in Spanish (instrucciones de uso) and English (instructions for use). |
| (t) in the case of devices that are composed of substances or of 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, warnings and precautions, where appropriate, related to the general profile of interaction of the device and its products of metabolism with other devices, medicinal products and other substances as well as contra- indications, undesirable side-effects and risks relating to overdose; | Not applicable as the product is a SW hosted on a server, which has no contact with the human body of the patients. |
| (u) in the case of implantable devices, the overall qualitative and quantitative information on the materials and substances to which patients can be exposed; | Not applicable as the product is a SW hosted on a server, which has no contact with the human body of the patients. |
| (v) warnings or precautions to be taken in order to facilitate the safe disposal of the device, its accessories and the consumables used with it, if any. This information shall cover, where appropriate: — infection or microbial hazards such as explants, needles or surgical equipment contaminated with potentially infectious substances of human origin, and — physical hazards such as from sharps. If in accordance with the point (d) of Section 23.1 no instructions for use are required, this information shall be made available to the user upon request; |
Not applicable, as the product is a SW hosted on a server and not a physical product, so no disposal process is associated with it. |
| (w) for devices intended for use by lay persons, the circumstances in which the user should consult a healthcare professional; | Not applicable because the SW is published for academic purposes and is therefore not intended for use by laymen. |
| (x) for the devices covered by this Regulation pursuant to Article 1(2), information regarding the absence of a clinical benefit and the risks related to use of the device; | It does not apply because the medical device is a software based on Artificial Intelligence, so its results should be used as a support for doctors, never as a final decision-maker. In addition, its use does not directly influence the risks or benefits for patients, but will always depend on the doctor. |
| (y) date of issue of the instructions for use or, if they have been revised, date of issue and identifier of the latest revision of the instructions for use; | A table with the version number and date of each partner is available on page 2 of the instructions for use, described both in Spanish (instrucciones de uso) and English (instructions for use). |
| (z) a notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established; | Point "0 Introduction and background information" of the instructions for use, described both in Spanish (instrucciones de uso) and English (instructions for use), states that if a fault or incorrect use is detected, the Biomedical Data Laboratory (BDSLab) of the Universitat Politècnica de València (UPV) should be notified, providing a link to the "Contact" section of the group's website. However, if a serious incident occurs, it is indicated that this must also be notified to the Spanish Agency of Medicines and Health Products (AEMPS) by emailing psinvclinic@aemps.es. |
| (aa) information to be supplied to the patient with an implanted device in accordance with Article 18; | Not applicable as the product is not implantable. |
| (ab) for devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, minimum requirements concerning hardware, IT networks characteristics and IT security measures, including protection against unauthorised access, necessary to run the software as intended. | Point "0 Introduction and background information" of the instructions for use, described both in Spanish (instrucciones de uso) and English (instructions for use), indicates that ONCOhabitats is hosted on a secure server at the Universitat Politècnica de València (UPV), under secure protocols and following the premises of the data protection delegate of the University itself. As for the necessary hardware, it is physically located in a server room with an electronic lock that can only be accessed by authorised personnel. Likewise, the data entered by the user and generated by the SW are stored in accordance with the security regulations in force. |
Bibliography
Del Mar Álvarez-Torres, M. et al. (2020) ‘Robust association between vascular habitats and patient prognosis in glioblastoma: An international multicenter study’, Journal of magnetic resonance imaging: JMRI, 51(5), pp. 1478–1486. Available at: https://doi.org/10.1002/jmri.26958.
