Information for use (IFU) and labels must be provided with every In-Vitro diagnostic medical device, containing information to identify the device, its manufacturer and any relevant safety and performance information for the user or any other person.
Such information may be found on the device itself, in the packaging, or in the user instructions (IFU), and if the manufacturer has a website, it must be made available and maintained up to date on the website.
Updates in Labelling Requirements (Chapter III, EU IVDR)
- The name or trade name of the device
- The UDI carrier as referred to in Article 24 and Part C of Annex VI
- 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
- Where relevant, an indication of the net quantity of contents, expressed in terms of weight or volume, numerical count, or any combination of thereof, or other terms which accurately reflect the contents of the package
- Where appropriate, an indication of the sterile state of the device and the sterilisation method, or a statement indicating any special microbial state or state of cleanliness
- Warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device or 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
- If the instructions for use are not provided in paper form in accordance with point (f) of Section 20.1, a reference to their accessibility (or availability), and where applicable the website address where they can be consulted
- 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
- If the device is intended for self-testing or near-patient testing, an indication of that fact
- Where rapid assays are not intended for self-testing or near-patient testing, the explicit exclusion hereof
- Where device kits include individual reagents and articles that are made available as separate devices, each of those devices shall comply with the labelling requirements and with the requirements of this Regulation
- The label for devices for self-testing shall bear the following particulars:
(i) The type of specimen(s) required to perform the test (e.g. blood, urine or saliva)
(ii) The need for additional materials for the test to function properly
(iii) Contact details for further advice and assistance
The name of devices for self-testing shall not reflect an intended purpose other than that specified by the manufacturer - Information on the packaging which maintains the sterile condition of a device (‘sterile packaging’):
The following particulars shall appear on the sterile packaging:
(a) an indication permitting the sterile packaging to be recognised as such,
(b) a declaration that the device is in a sterile condition,
(c) the method of sterilisation,
(d) the name and address of the manufacturer,
(e) a description of the device,
(f) the month and year of manufacture,
(g) an unambiguous indication of the time limit for using the device safely, expressed at least in terms of year and month and, where relevant, the day, in that order,
(h) an instruction to check the instructions for use for what to do if the sterile packaging is damaged or unintentionally opened before use
Updates in Information for use Requirements(CHAPTER III, EU IVDR)
- The device’s intended purpose:
- what is detected and/or measured
- its function (e.g. screening, monitoring, diagnosis or aid to diagnosis, prognosis, prediction, companion diagnostic)
- the specific information that is intended to be provided in the context of:
—a physiological or pathological state;
— congenital physical or mental impairments;
— the predisposition to a medical condition or a disease;
— the determination of the safety and compatibility with potential recipients;
— the prediction of treatment response or reactions;
— the definition or monitoring of therapeutic measures - whether it is automated or not
- whether it is qualitative, semi-quantitative or quantitative
- the type of specimen(s) required
- where applicable, the testing population; and
- for companion diagnostics, the International Non-proprietary Name (INN) of the associated medicinal product for which it is a companion test
- The intended user, as appropriate (e.g., self-testing, near patient and laboratory professional use, healthcare professionals
- For devices intended for use in combination with or installed with or connected to other devices and/or general-purpose equipment:
— information to identify such devices or equipment, in order to obtain a validated and safe combination, including key performance characteristics, and/or
— information on any known restrictions to combinations of devices and equipment.
- In-use stability which may include the storage conditions, and shelf life following the first opening of the primary container, together with the storage conditions and stability of working solutions, where this is relevant
- If the device is supplied as sterile, an indication of its sterile state, the sterilisation method and instructions in the event of the sterile packaging being damaged before use
- Information that allows the user to be informed of any warnings, precautions, measures to be taken and limitations of use regarding the device. That information shall cover, where appropriate:
- warnings, precautions and/or measures to be taken in the event of malfunction of the device or its degradation as suggested by changes in its appearance that may affect performance,
- 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, therapeutic treatment or other procedures such as electromagnetic interference emitted by the device affecting other equipment,
- 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,
- 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,
- if the device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, decontamination, packaging and, where appropriate, the validated method of re-sterilisation. Information shall be provided to identify when the device should no longer here used, such as signs of material degradation or the maximum number of allowable reuses
- Any warnings and/or precautions related to potentially infectious material that is included in the device
- Where relevant, requirements for special facilities, such as a clean room environment, or special training, such as on radiation safety, or particular qualifications of the intended user
- Conditions for collection, handling, and preparation of the specimen
- Details of any preparatory treatment or handling of the device before it is ready for use, such as sterilisation, final assembly, calibration, etc., for the device to be used as intended by the manufacturer
- 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, including cleaning and 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;
— methods for mitigating the risks encountered by persons involved in installing, calibrating or servicing devices.
- Where applicable, recommendations for quality control procedures
- The metrological traceability of values assigned to calibrators and control materials, including identification of applied reference materials and/or reference measurement procedures of higher order and information regarding maximum (self-allowed) batch to batch variation provided with relevant figures and units of measure
- Assay procedure including calculations and interpretation of results and where relevant if any confirmatory testing shall be considered; where applicable, the instructions for use shall be accompanied by information regarding batch to batch variation provided with relevant figures and units of measure
- Where relevant, clinical performance characteristics, such as threshold value, diagnostic sensitivity and diagnostic specificity, positive and negative predictive value
- Where relevant, reference intervals in normal and affected populations
- Information on interfering substances or limitations (e.g. visual evidence of hyperlipidaemia or haemolysis, age of specimen) that may affect the performance of the device
- 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 consumables contaminated with potentially infectious substances of human origin
- environmental hazards such as batteries or materials that emit potentially hazardous levels of radiation)
- physical hazards such as explosion
- A notice to the user that any serious incident that has occurred in relation to the device shall be reported to the manufacturer and the competent authority of the Member State in which the user and/or the patient is established
- Where device kits include individual reagents and articles that may be made available as separate devices, each of these devices shall comply with the instructions for use requirements contained in this Section and with the requirements of this Regulation
- 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
- In addition, the instructions for use for devices intended for self-testing shall comply with all of the following principles:
- the information provided shall include a statement clearly directing that the user should not take any decision of medical relevance without first consulting the appropriate healthcare professional, information on disease effects and prevalence, and, where available, information specific to the Member State(s) where the device is placed on the market on where a user can obtain further advice such as national helplines, websites
- for devices intended for self-testing used for the monitoring of a previously diagnosed existing disease or condition, the information shall specify that the patient should only adapt the treatment if he has received the appropriate training to do so
Symbols used on IVDR labels and IFUs
Please note: Symbols listed here are used in common for Medical Devices and IVDs
Manufacturing Information Symbols
| Symbol | Description |
 | Manufacturer Symbol to be accompanied with Manufacturer name and address adjacent to the symbol |
 | EU Authorised Representative Symbol to be accompanied with Local EU authorised representative name and address. If the Authorised Representative is the Importer and Distributor, these details need not be duplicated. |
 | Date of manufacture Format YYYY-MM- DD For a “Sterile” device, Manufacturing Date and Expiration Date symbols to be mentioned |
 | Country of manufacture Indicates the country of manufacture of the medical device. In the application of this symbol, the “CC” shall be replaced by either the two-letter country code or the three-letter country code defined in ISO 3166-1. |
 | Use by Date or Expiry Date Represents Expiration Date Can be used in place of “Date of manufacture” For a ‘Sterile’ device, Manufacturing Date and Expiration Date symbols to be mentioned |
 | Information available on web Indicates that patient can get additional information on web about the product. |
 | Importer Required to be provided with their name, registered trade mark and address Importer to add label to the device ensuring the label does not obscure any information on the label provided by the manufacturer |
 | Distributor Required to be provided with their name, registered trade mark and address |
 | CE marking (with notified body number) Symbol to indicate “CE” conformity XXXX not present for self-declaration devicesXXXX replaced with the respective notified body number that assessed the medical device |
 | In-Vitro Diagnostic Medical Device To indicate the product is an In- Vitro Diagnostic Medical Device |
IVD Symbols
| Symbol | Description |
 | For self-testing A lay person can use the device marked with this symbol even without professional medical experience. |
 | Not for self-testing Indicates that devices must be used by trained professionals in an appropriate setting. |
 | For near-patient testing Indicates that the device must be used by a trained professional in a near-patient setting. |
 | Not for near-patient testing Indicates that device must be used by trained professional in laboratory setting. |
Identification / Product Traceability Symbols
| Symbol | Description |
 | Batch code or Lot code Batch or Lot code to be mentioned adjacent to the symbol |
 | Catalogue number Indicated catalogue number to be mentioned adjacent to the symbol |
 | Serial Number Indicates manufacturer serial number to identify device (Mandatory for implantable devices) |
 | Model number To identify the model number or type number of the product This symbol to be accompanied by the model number or catalogue number of the product, adjacent to the symbol |
 | Unique Device Identifier Contains 2 parts UDI-DI – Device Identifier & UDI-PI – Production Identifier Symbol is not mandatory, can be indicated using Bar Code/RFID/QR Code |
 | Patient Number Indicates a unique number associated with an individual patient NOTE # is part of the symbol. The patient number appears adjacent to the symbol. |
Sterility Information
| Symbol | Description |
 | Non-Sterile Indicates a medical device has not been subjected to a sterilisation process |
 | DO NOT Re-sterilize Indicates the device should not be subjected to any re-sterilization |
 | Sterile* Indicates the device has been subjected to sterilization process / methods |
 | Sterilized using Aseptic techniques* Subject to sterilization using aseptic processing techniques |
 | Sterilized using Ethylene dioxide* Subject to sterilization using Ethylene dioxide |
 | Sterilized using irradiation* Subject to sterilization using irradiation |
 | Sterilized using vaporized hydrogen peroxide* Subject to sterilization using vaporized hydrogen peroxide |
 | Single Sterile Barrier Indicates a single sterile barrier system This symbol can be used in adjacent or in combination with Sterile* symbols |
 | Double Sterile Barrier Indicates two sterile barrier systems This symbol can be used in adjacent or in combination with Sterile* symbols |
 | Single Sterile with protective packaging inside Indicates a single sterile barrier system with protective packaging inside NOTE: The protective packaging located inside the sterile barrier system is designed to prevent damage to the contents or to help with aseptic presentation. It does not provide a microbial barrier to maintain sterility |
| Single Sterile with protective packaging outside Indicates a single sterile barrier system with protective packaging outside NOTE: The protective packaging located outside the sterile barrier system is designed to prevent damage to the sterile barrier system and the contents. The protection can be against physical hazards, particulate contamination or other environmental hazards, but it does not include a microbial barrier. |
Cautions / Warning / Information to User
| Symbol | Description |
 | Cautions to use the device Indicates user to consult for important cautionary information such as warnings |
 | Refer to Instructions for Use (IFU) or refer to electronic Instructions for Use (eIFU) Indicates need for the user to consult instructions for use to use the device appropriately and safe For eIFU mention web address alongside the IFU symbol |
 | Translation To identify that the original medical device information has undergone a translation which supplements or replaces the original information This symbol shall be accompanied by the name and address of the entity that is responsible for the translation activity, adjacent to the symbol. If multiple symbols (i.e., Authorized Representative, Importer, Distributor, Translation, or Repackaging) identify the same responsible entity, the name and address need not be duplicated. This symbol should only be used when the translation activity was undertaken by someone other than the manufacturer. |
 | Repackaging To identify that a modification to the original medical device packaging configuration has occurred. This symbol shall be accompanied by the name and address of the entity that is responsible for the repackaging activity, adjacent to the symbol If multiple symbols (i.e., Authorized Representative, Importer, Distributor, Translation, or Repackaging) identify the same responsible entity, the name and address need not be duplicated. This symbol should only be used when the repackaging activity was undertaken by someone other than the manufacturer. |
 | Single Patient – multiple use Indicates a medical device that may be used multiple times or multiple procedures on a single patient |
 | DO NOT Re-Use Device intended only for single use |
 | Indicates do not use if package is damaged Also indicates, do not use device if sterile barrier or its packaging is compromised |
 | Biological risks Indicates that there are potential biological risks associated with the medical device |
 | Contains natural rubber latex Indicates the presence of natural rubber or dry latex as a material, within the construction of the device or in the packaging of the medical device |
Device containing substances or incorporates
| Symbol | Description |
 | Contains human blood or plasma derivative Indicates a medical device that contains or incorporates human blood or plasma derivatives |
 | Contains medicinal substance Indicates a medical device that contains or incorporates a medicinal substance |
 | Contains tissues or cell derivatives of animal origin Indicates a medical device that contains or incorporates a medicinal substance |
 | Contains tissues or cell derivatives of human origin Indicates a medical device that contains biological tissue, cells, or their derivatives, of human origin |
 | Contains hazardous substances Indicates a medical device that contains substances that can be carcinogenic, mutagenic, reprotoxic (CMR), or substances with endocrine-disrupting properties |
 | Contains nano materials Indicates a medical device that contains nano materials |
Storage Symbols
| Symbol | Description |
 | Fragile, handle with care Indicates a medical device that can be broken or damaged if not handled carefully |
 | Keep dry Indicates a medical device that needs to protected from moisture |
 | Temperature Limit Indicates the temperature limits to which the medical device can be safely exposed |
 | Humidity Limitation Indicates the humidity range to which the medical device can be safely exposed |
 | Atmospheric pressure limitation Indicates the atmospheric pressure range to which the medical device can be safely exposed |