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IFU for Medical Devices

Ferry Vermeulen Law & Legislation

Creating instructions for use (IFU) for medical devices requires quite a lot of responsibility.

In fact, you need to combine your techcomm skills with project management, administrative and legal skills. Luckily, what needs to be included in the instructions for use for medical devices has been determined in relevant legislation.

If there is any industry in which it is important to make sure that users can use devices safely, effectively and efficiently, it is the medical industry.

And let's not forget the importance of decreasing your liability by means of adequate instructions for use.

If you want to create IFU for medical devices you need to be aware of both the content and the process to follow.

In this guide I’m going to show you everything you need to know when creating IFU for medical devices.

I will not only show you how to create IFU for the European market, but also for the US market.

Let’s dive right in!

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REQUIREMENTS FOR MEDICAL DEVICES

About the (EU) 2017/745 Regulation

The (EU) 2017/745 Regulation replaces the Medical Devices Directive 93/42/EEC and the Active Implantable Medical Devices Directive 90/385/EEC.

The new Medical Device Regulation will enter into force from May 26th 2020.

First of all, why has the directive become a regulation and what's the difference between the two?

A regulation has binding legal force throughout the Member States of the EEA. A directive lays down certain results that must be achieved, but each individual Member State is free to decide how directives will be transposed into national laws.

For example, in the Netherlands, labels and instructions for use must be in Dutch. This requirement is contained in Article 6 (2) of the Medical Devices Decree (Dutch: Besluit medische hulpmiddelen) and article 6 of the In-vitro Diagnostic Medical Devices Decree.

The example above describes how the Medical Device Directive is transposed into Dutch law. With the replacement of the directive by a regulation, those individual national laws will disappear.

The regulation harmonises the rules for the placing on the market and putting into service of medical devices and their accessories on the EU market. 

The purpose of the regulation is to ensure the free movement of safe medical devices within the EU community. 

But what exactly is a medical device?

A medical device is defined as any instrument, apparatus, appliance, software, implant, reagent, material or other item intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the following specific medical purposes: 

  • diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, 
  • diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, 
  • investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, 
  • providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations. 

The regulation requires all these devices to:

  • be suitable for their intended purpose; 
  • be safe and effective;
  • not compromise the clinical condition or the safety of patients, or the safety and health of users. 

The regulation also applies to accessories for medical devices and to certain product groups without a medical purpose, such as contact lenses, products intended to be totally or partially introduced into the human body through surgically invasive means, products intended for the purpose of modifying the anatomy or fixation of body parts, high intensity electromagnetic radiation emitting equipment and equipment intended for brain stimulation.

The regulation does not apply to in vitro diagnostic medical devices, medicinal products, cosmetic products, human blood, transplants and food.

Classification: List of Medical Devices Classes

Medical devices have been divided into several classes by the regulation:

  • Class I
  • Class IIb
  • Class IIb
  • Class III

A Notified Body must be involved in the assessment of classes IIa, IIb and III of medical devices as categorised by the Medical Device Regulation. The instructions for use are part of the conformity assessment procedure. They will be tested on completeness at least and sometime also on correctness.

Instructions for use must be part of a medical device. By way of exception, instructions for use are not required for class I and class IIa devices if such devices can be used safely without any such instructions.

That's why the classification of your device also determines if and how you should provide your instructions. 

Let's take a closer look at the classification.

List of Class I Medical Devices

Class I: These are the low risk medical devices.  They include:

  • Most non-invasive devices; 
  • Invasive devices intended for transient use; 
  • Reusable surgical instruments.

List of Class IIa Medical Devices

These are medium risk devices. They include:

  • most invasive devices intended for short-term use;
  • most surgically invasive devices intended for transient use;
  • most active therapeutic devices intended to administer or exchange energy;
  • most active devices intended for diagnosis and monitoring; 
  • most software intended to provide information which is used to make decisions about diagnosis or therapeutic purposes; 
  • most active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body;
  • most devices intended specifically to be used for disinfecting or sterilising medical devices;
  • devices specifically intended for recording of diagnostic images generated by X-ray radiation;
  • devices incorporating or consisting of nanomaterial if they present a negligible potential for internal exposure;
  • most invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to administer medicinal products by inhalation.

List of Class IIb Medical Devices

Class IIb are medium risk devices as well, but include:

  • most invasive devices intended for long-term use;
  • active devices intended to emit ionizing radiation for therapeutic purposes, including devices which control or monitor such devices, or which directly influence their performance;
  • most devices used for contraception or prevention of the transmission of sexually transmitted diseases;
  • all devices intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate, hydrating contact lenses, devices incorporating or consisting of nanomaterial if they present a low potential for internal exposure.

List of Class III Medical Devices

Class III are all high risk implantable devices. They include:

  • devices intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body;
  • active devices that are intended for controlling, monitoring or directly influencing the performance of active implantable devices;
  • all devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the devices;
  • most devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non- viable or rendered non-viable;
  • devices incorporating or consisting of nanomaterial if they present a high or medium potential for internal exposure;
  • active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management by the device, such as closed loop systems or automated external defibrillators.

What Information Should be Included in the Instructions for Use?

Most likely by now you know that you have a Medical Device that must include instructions for use. The next question would be: What information do I need to put in my instructions?

The Regulation includes the following (slightly reworded and restructured) list: 

  • The (trade) name of the medical device;
  • The (trade) name (or registered trade mark) and the address of the manufacturer;
  • The date of issue of the instructions for use, or revision dates and information about where to find the latest revision of the instructions for use;
  • If applicable, an indication that the medical device contains or incorporates a medicinal substance (including a human blood or plasma derivative), tissues or cells (or their derivatives of human origin), or tissues or cells of animal origin (or their derivatives)
  • If applicable, information about substances that are subject to label requirements (according to section 10.4.5. of the Regulation);
  • If the medical device is supplied sterile, an indication of its sterile state and the sterilisation method;
  • If applicable, instructions for when a sterile packaging is damaged or accidently opened before use;
  • Instructions for sterilisation (only applies to medical devices that are supplied non-sterile and should be sterilised before use);
  • If applicable, a statement when the medical device is intended for single use;
  • In the case of medical devices that are composed 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, including quantitative information on the main constituent(s) responsible for achieving the principal intended action;
  • The intended purpose, including any contra-indications, a specification of indications, the patient target group(s), and of the intended users;
  • Training or qualification requirements and information about the device user and/or other persons and information about special facilities;
  • Storing and handling information;
  • Information that is needed to verify if the medical device is properly installed and ready to be used as intended. This information must include, where relevant, instructions regarding maintenance, cleaning/disinfection, replacement of consumables, calibration and how to eliminate risks;
  • Detailed information about all preparatory treatments or handling of the device before it is ready for use or during its use (e.g. sterilisation, calibration, final assembly). Also, the levels of disinfection required and the available methods for achieving these levels must be included.
  • If applicable, the clinical benefits that can be expected;
  • If applicable, links to the summary of safety and clinical performance (see article 32 of the Regulation);
  • The performance characteristics of the medical device;
  • If applicable, information allowing the healthcare professional to verify if the medical device is suitable to work with.
  • If applicable, information allowing the healthcare professional to select the correct corresponding software and accessories;
  • Any residual risks, contra-indications and any undesirable side-effects. This must include information to be conveyed to the patient.
  • Any relevant warnings, precautions, contraindications, measures to be taken and limitations of use regarding the device. 
  • All relevant warnings and precautions when substances are intended to be introduced into the human body;
  • Specifications the user requires to use the medical device appropriately, e.g. if the device has a measuring function, the degree of accuracy claimed for it must be given;
  • For reusable devices, information on the processes for cleaning, disinfection, packaging and, if applicable, the validated method of re-sterilisation as determined by the country where the product is sold and used. When there are, for example, signs of degradation or in case the maximum number of allowable reuses has been reached, it must be mentioned that the device shall not be used anymore;
  • If applicable, a statement that a medical device can be reused when it is reconditioned under the responsibility of the manufacturer;
  • Devices intended for single use only must contain information about the risks if the device were to be re-used;
  • Medical devices intended for use together with other devices and/or general purpose equipment must include information to identify such devices or equipment so they can be safely used together and/or information about any known restrictions to combinations of devices and equipment;
  • For devices emitting radiation for medical purposes, detailed information about the nature, type and the intensity and distribution of the emitted radiation, and information about how to protect users, patients or other persons shall be given; 
  • For implantable devices, the overall qualitative and quantitative information about the materials and substances to which patients can be exposed;
  • For implanted devices, information to identify the device (name, serial number etc), warnings and precautions regarding reciprocal interference, medical examinations or environmental conditions, information about the expected lifetime and any other information to ensure safe use of the device.
  • Detailed instructions for the safe disposal of the medical device, its accessories and the consumables.
  • A description of when the user should consult a healthcare professional (in case the device is intended for use by lay persons)
  • For groups of products without an intended medical purpose that are listed in Annex XVI of the Regulation (such as contact lenses and liposuction equipment) information regarding the absence of a clinical benefit and the risks related to use of the device.
  • A notice that users and/or patients must report any serious incident that has occurred in relation to the device to the manufacturer and the competent authority of the country in which the user and/or patient is established;
  • For devices that incorporate electronic programmable systems (including software, or software that are devices in themselves) the minimum requirements concerning hardware, IT networks characteristics and IT security measures necessary to run the software as intended must be given.

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You can find this overview in full in Chapter III of the Regulation. However, when you scan the entire Regulation for 'instructions for use', you find that this list is not complete.

In other sections, the following requirements can be found as well:

  • The CE marking must appear in the instructions for use (and on any sales packaging).
  • For implantable devices and for class III devices, the manufacturer must draw up a summary of safety and clinical performance. The manufacturer must mention in the instructions (or on the label) where this summary is available. The content of the summary has been determined in the Regulation.

For the sake of completeness, I suggest that you ctrl + f the Regulation for 'instructions for use' as well.

How to Comply with the Medical Device Regulation

So where do the instructions fit into the compliance process for Medical Devices? Let's put this into context.

In order to comply with the Medical Device Regulation, you should follow the six steps of the CE Marking process.

  1. Check whether your product falls under the Regulation and identify other applicable regulations, directives and standards to use in order to comply.
  2. Identify which requirements of the legislation that you found in step 1 apply to your specific product.
  3. Determine if your medical device can be self-assessed, or if you need a Notified Body. For medium to high risk devices, the manufacturer needs to hire a Notified Body to assess the medical device and determine its conformity to the regulation. For low risk devices (class I) the assessment is a self-certification.
  4. Assess the product’s conformity.
  5. Compile the technical file. The technical file includes a detailed device description and specification as determined in Annex II of the Regulation, the label or labels on the device and on its packaging, the instructions for use, design and manufacturing information, general safety and performance requirements, benefit-risk analysis and risk management and product verification and validation information.
  6. Affix the CE mark and draw up the declaration of conformity

CE marking process

How to Apply Harmonised Standards

Each medical device that falls within the scope of the Medical Device Regulation has to meet the requirements of the Regulation.

These requirements are very general in nature as they apply to all medical devices.

You can use harmonised standards to prove compliance with the essential requirements of the Regulation. Products that meet the requirements of harmonised standards benefit from a presumption of conformity with the corresponding essential requirements.

A C-type standard provides specifications for a given category of device. This is a so-called vertical standard.

There are C-type harmonised standards for all kinds of categories of medical device, such as X-ray equipment, surgical luminaires and radiotherapy simulators, just to name a few. For an overview of available harmonised standard, see here

These standards may contain additional, or more detailed, requirements for the instructions for use.

It is recommended to verify whether there are any harmonised standards for your device type and accordingly identify what requirements for the instructions these contain. 

Besides the vertical standards, there are also horizontal standards that you can apply in order to comply with the requirements for the European legislation.

A horizontal standard is a standard that applies to all product groups, such as machinery, toys, medical devices and personal protective equipment, and is not limited to just one (vertical) product category.

The horizontal standard for Information for Use is the IEC/IEEE 82079-1:2019 standard (note: at the time of writing, this standard has been published but is not yet part of the European Legislation Framework; therefore, until then, its predecessor, the ISO IEC 82079-1:2012 applies).

Let's have a look at the following example that shows us the difference between a general requirement in a directive/regulation versus a more detailed requirement in a standard.

The regulation tells us that 'the information and instructions provided by the manufacturer shall be easy for the lay person to understand and apply'. 

The 82079 standard gives many requirements for how you can assure that your instructions are understandable. Some of these requirements are:

  • apply the principles of minimalism;
  • make sure the information for use is usable and relevant for the target audiences with respect to their expected tasks and goals;
  • use consistent terminology;
  • use text fonts, safety signs and graphical symbols that are clearly legible for the target audiences;
  • assign the creation of information for use to competent persons.

Who Can Draw Up the IFU for Medical Devices?

I have given the answer already in the last bullet of the previous section: your instructions for use should be drawn up by a competent person.

So what is a competent person?

According to the 82079 standard, a competent person is 'a person who has acquired through training, qualifications or experience, or a combination of these, the knowledge and skills enabling that person to perform a specified task'.

The standard clearly describes the task-related competencies that the creation of information for use should include. These are, amongst others:

  • conducting research and analysing the life cycle of a product;
  • developing a content strategy;
  • gathering safety-related information;
  • developing content;
  • validating the correctness of the content.

A company should identify the tasks to be performed to achieve the required results. They should evaluate the competencies which are needed to perform these tasks successfully and designate the tasks and responsibilities to persons who cover these competencies.

In some cases, only one person may be assigned to cover all responsibilities and tasks but in large organizations several persons, or maybe even a team or whole department, may be set up.

How to Use an Information Management Process to Develop Better Instructions for your Medical Device

When creating instructions for medical devices, you will find out that there is more to do than just technical writing. 

You have to gather and analyse technical, marketing, compliance, legal and quality information. You have to structure and develop content and publish, distribute and maintain it,

Working closely with several departments is inevitable. 

Each collaborator will have his or her specific ideas about how the instructions for use must be written to comply with regulations and meet marketing objectives. 

An information management process can help you with this. Besides requirements for the instructions for use, the 82079 standard also gives requirements on the information management process.

The standard's starting point is that if you want to ensure that users can use a product safely, efficiently and effectively, your information management process should meet certain requirements.

The information management processes should be implemented for planning, designing, producing, and sustaining information for use. 

The information management process requirements apply to all medical devices that are NOT consumer products.

The following four information management process groups are defined in the 82079 standard:

  1. analysis and planning of information;
  2. design and development (this includes reviewing, editing, and testing);
  3. production and distribution of information for use; and
  4. sustainment (including maintaining and improving the instructions).

Regarding the analysis and planning of information, the standard states that instructional procedures have to be formulated based on a market analysis, or an analysis of the characteristics, needs and intended tasks of the target audiences.

This analysis can include, amongst others, an analysis of the target audience (such as experience, background, language, skills, tasks, working environment and available tools), media, information sources, risk management, contractual agreements and legal considerations.

The development process shall include, for example, the preparation of information design concepts, templates, information gathering, selection of a content structure; editing and reviewing the content and usability testing.

The production and distribution process should include the integration, preparation, reproduction, packaging and distribution of physical media or electronic copies of the information for use.

And lastly, the sustainment, maintenance and improvement process includes continual target audience feedback and the establishment of a method for receiving information on changes, updating and making these updates available.

For more details about this, consult the 82079 standard as there is simply too much information to cover it all here.

Which Media Can You Use for Publishing Your IFU Medical Devices?

In Europe, it is generally agreed for products that safety instructions at least should be provided with the product, meaning that all non-safety related instructions can be provided online.

When the European Commission replaces the IEC 82079-1:2012 Preparation of Instructions for Use by the IEC/IEEE 82079-1:2019 Preparation of Information for Use, most likely by the end of 2019, there will be less strict requirements.

Why?

Because the new standard states the following:

‘The supplier shall determine the media and format of the information for use according to the nature of the target audiences and based on their needs’

However, regulations for medical devices have always been somewhat of an outlier. 

Regulation (EU) No 207/2012 on electronic instructions for use of medical devices already mentioned that ‘for some medical devices the provision of instructions for use in electronic form instead of in paper form can be beneficial for professional users’.

This possibility of providing the instructions for use in electronic form instead of in paper form is limited to certain medical devices.

Risk analysis should be conducted to determine the appropriateness of electronic instructions for use.

When the following devices are intended for use exclusively by professional users and when the use by other persons is not reasonably foreseeable, their instructions may be provided in electronic form: 

  • implantable medical devices and their accessories intended to be used exclusively for the implantation or programming of a defined active implantable medical device;
  • fixed installed medical devices ;
  • medical devices and their accessories fitted with a built-in system visually displaying the instructions for use;
  • stand-alone software covered by Directive 93/42/EEC.

mediums for the instructions

Should You Translate Instructions for Medical Devices?

The short answer: yes!

The longer answer: 

The Regulation requires that the instructions are translated into the language(s) accepted by the Member States where the device is made available to the user or patient.

Most, if not all, Member States require the instructions to be translated, but from a product liability point of view, it is always best to translate the instructions.

Also, the label or labels on the device and on its packaging must be provided in the languages accepted by the Member States where the medical device is envisaged to be sold.

The translation requirement also applies to the EU declaration of conformity.

What are the Labelling Requirements for Medical Devices in Europe?

Although this post is about the IFU, I think it makes sense to briefly discuss the medical device labelling requirements as well.

Labels of Medical Devices label shall bear the following:

  • the name/trade name of the medical device;
  • details necessary for a user to identify the device, the contents of the packaging and, where it is not obvious to the user, the intended purpose of the device;
  • the name and address of the manufacturer;
  • if the business is outside the European Union, the name and address of the authorised representative;
  • where applicable, an indication that the device contains or incorporates a medicinal substance (including a human blood or plasma derivative), tissues or cells of human origin or tissues or cells of animal origin;
  • where applicable, information labelled in accordance with section 10.4.5. of the regulation;
  • the lot number or the serial number of the medical device;
  • the UDI carrier
  • an unambiguous indication of the time limit for using or implanting the device safely;
  • the date of manufacture (only where there is no indication of the date until when it may be used safely); 
  • an indication of any special storage and/or handling conditions that apply;
  • if the device is supplied sterile, an indication of its sterile state and the sterilisation method;
  • warnings or precautions to be taken;
  • 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;
    • 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;
  • for active implantable devices, the serial number, and for other implantable devices, the serial number or the lot number.

What are the Requirements for IFU for Medical devices in the U.S.?

All of the above information was about the requirements that Europe has for the instructions for medical devices. How are things in the U.S. organised?

In the United States, the Code of Federal Regulations (CFR) Title 21 Parts 800 – 1299 applies to medical devices. Part 801.5 mentions the directions for use. The text is as follows:

“PART 801 -- LABELING

Subpart A--General Labeling Provisions

Sec. 801.5 Medical devices; adequate directions for use.

Adequate directions for use mean directions under which the layman can use a device safely and for the purposes for which it is intended. Section 801.4 defines intended use. Directions for use may be inadequate because of, among other reasons, omission, in whole or in part, or incorrect specification of:

(a) Statements of all conditions, purposes, or uses for which such device is intended, including conditions, purposes, or uses for which it is prescribed, recommended, or suggested in its oral, written, printed, or graphic advertising, and conditions, purposes, or uses for which the device is commonly used; except that such statements shall not refer to conditions, uses, or purposes for which the device can be safely used only under the supervision of a practitioner licensed by law and for which it is advertised solely to such practitioner.

(b) Quantity of dose, including usual quantities for each of the uses for which it is intended and usual quantities for persons of different ages and different physical conditions.

(c) Frequency of administration or application.

(d) Duration of administration or application.

(e) Time of administration or application, in relation to time of meals, time of onset of symptoms, or other time factors.

(f) Route or method of administration or application.

(g) Preparation for use, i.e., adjustment of temperature, or other manipulation or process.”

As this text is legislative drafting, it is mandatory and thus should be obeyed.

The document Guidance on Medical Device Patient Labelling, that has been published by the FDA, serves as a supporting document and describes in more detail what content to include in the instructions.

The guidance says the following about the instructions.

  • Both risk/benefit information and instructions for use may be included.
  • You should consider developing instructions for use when patients or lay caregivers need to:
    • maintain the device;
    • monitor and report on the operation or output of the device (e.g., pacemakers, glucose monitors);
    • explain the operation of the device to others;
    • explain the patient’s medical situation to others;
    • know how to alter their lifestyles or care regimens to properly integrate the use of the device; and/or
    • know how to safely dispose of the device.
  • You should consider developing both risk/benefit information and instructions for use when patients or lay caregivers need to:
    • operate, interpret, and manipulate the device;
    • know how to be careful in using the device, such as understanding the basis for warnings, precautions, and contraindications;
    • co-operate with the prevention, treatment, or diagnosis of an illness.
  • If appropriate, give instructions on post-operative or post-procedural care.
  • State why it is important to follow the care regimen explained in the medical device patient labelling. This will help to motivate the user to follow the instructions.
  • The user needs to know what to do, how to do it, and when to do it. The operating instructions should:
    • focus on how to operate the device. It is usually not necessary to provide a detailed explanation for lay users of the mechanism of action of the device or why it does what it does. That approach can lead to information overload.
    • assume that the user does not have device or medical knowledge or ability;
    • provide logically ordered steps for the task and make the user aware of the importance of doing the steps in order;
    • state the purpose and the expected outcome of each task.
    • tell the user what steps are essential and which ones are optional;
    • be written at an eighth-grade reading level or below to reach most of the population;
    • be clear the first time they are read. Many people do not reread something they do not understand.
  • Give clear setup instructions. If a user is not responsible for the setup of the device, tell the user this and omit the setup instructions. Include in setup instructions for the lay user:
    • a parts list, if appropriate;
    • a list of materials and tools needed for setup;
    • unpacking instructions, if appropriate;
    • instructions on proper disposal of packing materials or how to return packaging to you for reuse;
    • directions for where the device should be placed, such as a table top or floor.  Also state if the device should remain in one place after setup.
    • any warnings or safety instructions specifically related to setup, placed right before the corresponding task or instruction;
    • results of an incorrect setup;
    • numbered setup instruction steps in logical order;
    • any special preparation required before first use of the device, such as cleaning or disinfecting;
    • space to write in user-specific instructions;
    • who to call if there is a problem. You may refer users to the assistance section in the medical device patient labelling.
  • If the device requires any type of checkout procedure for safety and effectiveness, clearly and completely explain this process. Include:
    • when the checkout should be done, such as at the time of setup and/or before each use;
    • sep-by-step procedures for checking proper function of necessary parts of the device;
    • what to do if the checkout shows that the device is not working properly.
    • who to call if there is a problem;
    • a clock or calendar graphic may be useful to show the user correct times or days to check the device.
  • Give clear and easy-to-follow operating instructions. These instructions should include:
    • special preparation the user needs before operation, such as hand washing or device warm-up procedures;
    • any warnings or safety instructions specifically related to operation, placed immediately before the corresponding task or instruction;
    • results of incorrect operation;
    • operating steps in logical order, with the expected results;
    • space for user-specific instructions;
    • who to call if there is a problem. You may refer users to the assistance section in the medical device patient labelling.
  • State the importance of monitoring the activity of the device. This section explains that the user needs to make sure the device is acting the way it should. Give examples of what to check to make sure the device still works properly. For example, check to see that leads are connected, wires are not damaged, and the power is supplied to the device.
  • Give clear and complete cleaning instructions: 
    • List the supplies needed.
    • Give step-by-step procedures.
    • State how often to clean the device.
    • Tell the user what cleaning accomplishes.
    • Tell the user what the results of failure to clean will be.
    • Include appropriate warnings and precautions for cleaning agents.
    • Describe the results of using improper cleaning solutions or methods.
    • Include suggestions for the proper disposal of the suggested cleaning agents, if appropriate.
  • Provide maintenance instructions.
    • Clearly describe what maintenance actions are the responsibility of the user.
    • If a particular kind of user, such as the lay user at home, is not responsible for maintenance, briefly outline proper maintenance actions, who is responsible, and how often the action should be done.
    • If the device has some maintenance procedures to be done by the user and some done by others, such as the biomedical engineer, you may wish to write this section in two parts.
    • The two parts will help make clear to users what they should and should not be doing to maintain the device.
  • Provide storage instructions.
    • Clearly describe proper preparation for storage and storage conditions.
    • State the results of improper storage conditions.
    • If extended storage may affect the device, inform the user.
    • It may be necessary to include information that addresses extended storage in the sections on setup, checkout, operation, and maintenance.
  • Provide failure time information.
    • State how long the device will last.
    • State what to expect when the device fails.
    • Let the user know if it is safe or dangerous when it fails and the effect on the patient.
    • Include this type of information in the Risks and Benefits section of the medical device patient labelling if appropriate.
  • When appropriate, explain how to safely dispose of the device;
  • Provide accessory information.
    • If the device comes with or is used with accessories, discuss all appropriate content areas for each accessory.
    • You could have a separate accessories section or include information on the accessories in the content areas that apply.
    • You may need to include a general warning at the beginning of the medical device patient labelling, advising users of problems that may occur if they use accessories other than those you recommend.
  • If the patient will receive an additional device after an operation or procedure, include information about the additional device in the medical device patient labelling. Describe why this additional device would be needed, what symptoms might be expected post-treatment, and any other information about the additional device that has an impact on the safe and effective use of the primary device.
  • Provide an easy-to-find troubleshooting section.
  • You could include the following additional information:
    • clinical study information;
    • disease and self-care information;
    • adverse events;
    • warranty;
    • travel or international use.
  • an index;
  • date of printing;
  • user assistance information.

A few last notes:

  • Besides these directions on the content, the guide also gives guidance on readability;
  • Besides this legislation and guidance document and general 'horizontal' standards, such as the ANSI Z535.6, there are no vertical standards for the instructions for medical devices in the U.S.

Conclusion

Medical Devices are the most heavily regulated of products. 

Also, the instructions have to fulfil quite a lot of requirements.

As there is a lot incomplete information out there on the internet, I created this post for the sake of creating better information for use as well as happier and safer users.

So, go and create your IFU for medical devices yourself or send us an email if you are looking for support.

You can also buy our instructions for use medical device template.

As always, leaving a short comment when this post is of use would be highly appreciated!