MDR LABELLING REQUIREMENTS
[A] NON-ACTIVE MEDICAL DEVICES
Information on the Label
- Name or trade name of the device.
- Necessary details for a user to identify the device, the contents of the packaging and the intended purpose of the device.
- The name, registered trade name or registered trademark and the address of its registered place of business.
- Its registered place of business outside the Union, the name of the authorized representative and address of the registered place of business of the authorized representative.
- 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
- Where applicable, information labelled in accordance with where devices contain substances
- which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’), of category 1A or 1B, or
- substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health or, once a delegated act has been adopted by the Commission pursuant to the first subparagraph of Article 5(3) of Regulation (EU) No. 528/2012, in accordance with the criteria that are relevant to human health amongst the criteria established there in.
- Where devices, parts thereof or materials used contain substances in a concentration above 0,1 % weight by weight (w/w), the presence of those substances should be labelled on the device itself and/or on the packaging for each unit or, where appropriate on the sales packaging, with the list of such substances.
- If the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials, information on residual risks for those patient groups and, if applicable appropriate precautionary measures should be given in the instructions for use.
- The lot number or the serial number of the device preceded by the words Lot Number or Serial Number or an equivalent symbol.
- The UDI carrier.
- An unambiguous indication of the time limit for using or implanting the device safely, expressed at least in terms of year and month
- Where there is no indication of the date until when it should be used safely, the date of manufacture should be provided. This date of manufacture should be included as part of the lot number or serial number, provided the date is clearly identifiable
- An indication of any special storage and/or handling condition that applies
- If the device is supplied sterile, an indication of its sterile state and the sterilization method.
- 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 should be kept to a minimum in which case more detailed information should appear in the instructions for use, taking into account the intended users;
- If the device is intended for single use, an indication of that fact.
- 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
- If the device is custom-made, the words ‘custom-made device’.
- An indication that the device is a medical device. If the device is intended for clinical investigation only, the words ‘exclusively for clinical investigation’.
- 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.
Information on the Instructions for Use (IFU)
The instructions for use should contain all of the following particulars:
- The particulars referred to in points (a), (c), (e), (f), (k), (l), (n) and (r) of Section B.1should be followed.
- The device’s intended purpose with a clear specification of indications, contra-indications, the patient target group or groups, and the intended users, as appropriate.
- A specification of the clinical benefits to be expected, were applicable.
- Links to the summary of safety and clinical performance (SSCP), were applicable.
- The performance characteristics of the device.
- Information allowing the healthcare professional to verify if the device is suitable and select the corresponding software and accessories were applicable.
- Any residual risks, contra-indications and any undesirable side-effects, including information to be conveyed to the patient in this regard.
- 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.
- Details of any preparatory treatment or handling of the device before it is ready for use or during its use, such as sterilization, final assembly, calibration, etc., including the levels of disinfection required to ensure patient safety and all available methods for achieving those levels of disinfection
- Any requirements for special facilities, or special training, or particular qualifications of the device user and/or other persons
- The information needed to verify whether the device is properly installed and is ready to perform safely and as intended 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
- Methods for eliminating the risks encountered by persons involved in installing, calibrating or servicing devices
- Instructions in the event of the sterile packaging being damaged or unintentionally opened before use if device is supplied sterile.
- If the device is supplied non-sterile with the intention that it is sterilized before use, the appropriate instructions for sterilization.
- 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-sterilization appropriate to the Member State or Member States in which the device has been placed on the market. Information should 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.
- An indication that a device can be reused only if it is reconditioned under the responsibility to comply with the general safety and performance requirements.
- If the device bears an indication that it is for single use, information on known characteristics and technical factors that could pose a risk if the device were to be re-used. This information should be based on a specific section of the risk management documentation, where such characteristics and technical factors should be addressed in detail.
- 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
- 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. The information should 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 affect safety.
- 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.
- Precautions related to materials incorporated into the device that contain or consist of CMR substances or endocrine-disrupting substances, or that could result in sensitization or an allergic reaction by the patient or user.
- 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.
- In case of implantable devices, the overall qualitative and quantitative information on the materials and substances to which patients can be exposed.
- 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 should cover, where appropriate:
- Infection or microbial hazards such as explants, needles or surgical equipment contaminated with potentially infectious substances of human origin.
- Physical hazards such as from sharps.
- For devices intended for use by lay person’s user should consult a healthcare professional.
- For the devices to the groups of products without an intended medical purpose, and/or clinical investigations, information regarding the absence of a clinical benefit and the risks related to use of the device should be provided.
- Date of issue of the instructions for use with its date of issue and identifier of the latest revision of the instructions for use.
- A notice to the user and/or patient that any serious incident 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.
- Information to be supplied to the patient with an implanted device as below
- Information allowing the identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address and the website who manufactures device.
- Any warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions.
- Any information about the expected lifetime of the device and any necessary follow-up.
- Any information to ensure safe use of the device by the patient.
- The information referred from point i to iv should be provided, for the purpose of making it available to the particular patient who has been implanted with the device, by any means that allow rapid access to that information and shall be stated in the language(s) determined by the concerned Member State. The information should be written in a way that is readily understood by a lay person and should be updated where appropriate. Updates of the information should be made available to the patient via the website.
- Provide the above information referred to in point (i) on an implant card delivered with the device along with implant card which should bear their identity.
- The implants such as sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors should be exempted from the obligations
[B] ACTIVE MEDICAL DEVICES
Information on label
- The particulars referred to in B.1 should be also same for active device were appropriate.
- For active implantable devices, the serial number or the lot number should be provided.
Information on Instruction for use.
- The particulars referred in Section B.2 from (a) to (z) should be followed for active devices were appropriate.
- 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;
- Information should 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 should cover following where appropriate:
- Warnings, precautions and/or measures to be taken in the event of malfunction of the device or changes in its performance that 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.
- 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 unauthorized access, necessary to run the software as intended.
[C] STERILE MEDICAL DEVICES
Information on the packaging which maintains the sterile condition of a device (‘sterile packaging’)
The following particulars should appear on the sterile packaging:
- An indication permitting the sterile packaging to be recognized
- A declaration that the device is in a sterile condition
- The method of sterilization
- The name and address of the manufacturer
- A description of the device
- If the device is intended for clinical investigations, the words ‘exclusively for clinical investigations’
- If the device is custom-made, the words ‘custom-made device’
- The month and year of manufacture
- An unambiguous indication of the time limit for using or implanting the device safely expressed at least in terms of year and month.
- An instruction to check the instructions for use for what to do if the sterile packaging is damaged or unintentionally opened before use.