United States IFU Legislation
The US has several federal agencies responsible for controlling and regulating public safety. Of them, the Health and Body portion is responsible for, among other things, medical devices. The Food and Drug Administration (FDA), acting under the Federal Food, Drug and Cosmetic Act (FFDCA), has created the Code of Federal Regulations Title 21 that covers medical devices and pharmaceuticals.
IFUs specifically are mentioned in the section regarding medical device labeling. “Labels” can take the form of either the sticker on the container, a brochure, booklet, manual, direction sheets, tags, or other similar accompanying literature.
While not exactly “instructions for use” per se, the labels you add to your medical devices are also under regulation by the FDA, so we’ll cover them now. Part 801 of the CFR mentioned previously is our point of focus, as it specifies:
- Intended use: Medical Device Manufacturers must designate all the potential applications of a medical device (i.e. what it’s used for and how to use it). Contraindications, by contrast, are instances where the device should not be used because the risk outweighs the benefit.
- Directions: In addition to the intended uses, the end-user must have clear directions on how to use a medical device. The details regarding recommended dosage amount, frequency, and method of application must be correct and complete.
- Manufacturer identification: The name and address of the manufacturer or distributor must be stated on the package. Phrases like “manufactured for…” or “distributed by…” are necessary when the name on the label is not the same as the producer.
- Clear, prominent statements: Required information must be displayed prominently in large text and cannot be cluttered with other design elements. Any symbols used outside of the FDA’s approved standard must be explained clearly as well.
- A consistent date format: Whether it’s an expiration or production date, YYYY-MM-DD is the approved format with a few exceptions.
- A Unique Device Identifier (UDI): This feature is required for most medical devices and even their accompanying software. It contains elements like a batch number, serial number, expiration date, and manufacturing date. It should be easily scanned by automated machines to quickly enter them into computer systems.
Labeling is only a portion of the medical device compliance process. Various other features and documentation must be included as well.
Quality System Regulations
This portion of the FDA’s rulings has to do with “current Good Manufacturing Practices” when it comes to manufacturing and releasing medical devices. In terms of Instructions for Use, the requirements are:
- Device identification on the cover, such as a picture, product name, or model number.
- Handling information to prevent damages during transportation.
- Storage information for safekeeping and prevention of cross-contamination.
- Accurate installation processes.
- A place to file service reports to the manufacturer.
The manufacturer must additionally have a system in place for receiving and evaluating consumer complaints and potentially responding with investigations.
Designing the Instruction Manual
The FDA publishes the Guidance on Medical Device Patient Labelling to help pharmaceutical companies write comprehensive instruction manuals for their medical devices. Some of what it asks for are the following.
- A table of contents: The instructions will inevitably be long and detailed, so keep organized and make navigation easy with a table of contents.
- A glossary: The manual should include consistent terminology to promote understanding. Explain the meaning of the terms and abbreviations you use, especially if your target audience likely does not have medical knowledge.
- A risk and benefit section: Health practitioners must make decisions for their patients on whether deploying the use of a medical device is worth it for someone’s specific circumstances. A risk/benefit section facilitates this decision.
- Clear operating instructions: Start with any relevant warnings or safety tips before listing out individual steps in a logical order. Include cleaning/maintenance instructions and have an emergency contact in place just in case. It’s recommended to have a list of components with a labelled diagram of each too.
- Troubleshooting: Medical devices might cause problems during use. Troubleshooting information is necessary in the manual for this reason, and it typically takes the form of a 3-column table listing out the exact problems, the cause, and the solution.
If a medical device is either not approved for marketing or is under current clinical evaluation, then it is considered an investigational device. As a result, there must be a clear indicator on the product label saying so. The FDA requires that investigational devices have the Investigational Device Exemption (IDE) so that information can be collected as part of premarket approval.
The FDA also specifies a series of IFU regulations regarding in vitro diagnostic devices, medical devices using biological samples to check on the status of one’s health.
European Union IFU Legislation
Compared to analogous legislation in the US, European IFU medical device validation regulations largely separate the requirements for device instructions, packaging, and labeling. They take the form of the (EU) 2017/745 Regulation.
The regulation covers all types of medical devices and their accessories but explicitly does not cover in vitro diagnostic devices, cosmetics, food, or medicinal products. For in vitro diagnostic medical devices, the Regulation (EU) 2017/746 instead will take over.
Classes of Medical Devices
The EU categorizes medical devices into 4 categories: Class I, Class IIa, Class IIb, and Class III.
- Class I involves low-risk medical devices like reusable surgical tools and any non-invasive devices.
- Class IIa are moderate risk with more invasive devices.
- Class IIb are similar to IIa except they also include more long-term invasive devices among others.
- Class III are the high-risk medical devices.
Only devices in Class I are exempt from official assessment by a Notified Body, and Instructions for Use are only required for Class IIb and Class III devices since they are complex enough to call for them. In vitro diagnostic devices have a separate but similar classification system of Class A, B, C, and D.
What To Include in the IFU
The EU Regulation contains plenty of data points that must be included in the Instructions for Use for a medical device. We recommend going through and finding all the sections that mention IFU and building a checklist from there. A few requirements we’ve picked out are the following.
- Name of the device
- Address of the manufacturer
- Indication of medicinal substances
- Whether or not the device is single-use or reusable
- Preparation procedures like sterilization, assembly, or calibration
- Intended use and contraindications
- Information for the healthcare professional to assist in the implementation of the medical device
- Relevant warnings and precautions
- Disposal instructions
- IT requirements to run any associated software
- The CE marking must be visible on the sales packaging
In vitro medical devices are also covered under the Regulation, and the regulatory requirements are similarly comprehensive. To ensure compliance, we recommend:
- Identifying which regulations, directives, and standards are applicable to your medical device. Then choose the requirements that apply to the exact type of medical device you are analyzing.
- Determining whether you can assess your own medical device or you need a Notified Body from the government to help. Keep in mind our Class distinctions above.
- Performing the assessment to check for compliance.
- Building a technical file, which includes the description, the label, Instructions for Use, and other important information.
- Applying the declaration of conformity to finish the process.
Another question worth asking is who to entrust your IFU writing to. The EU regulation actually uses the term “competent person,” which refers to anybody with experience, education, or qualifications in a particular task.
Whether you have a dedicated writer or a team of experienced IFU specialists, it’s your task to identify what needs to be done and who is competent in the related fields.
Pharmaceutical manufacturing companies have an opportunity to prove compliance with certain essential requirements by using harmonized standards. The C-type standard, for instance, covers a given category of devices, whether they are X-ray equipment, radiotherapy devices, or otherwise. Examples include:
- EN 455-1:2000: Medical gloves that can be only used once
- EN ISO 11990:2018: Laser equipment
- EN 14683:2019+AC:2019: Medical face masks
There are obviously far more out there, so double-check with the Regulations to see which ones are applicable to you.
The Information Management Process
Writing the Instructions for Use is about more than just technical writing. You have to tell your writers what to include and what information is accurate. To that end, businesses must gather and analyze all the technical specifications, compliance procedures, storage instructions, marketing objectives, and other relevant data first. Doing so requires strong collaboration amongst multiple departments.
An information management process helps determine exactly how the IFU will be written, hence why the 82079 standard mentions it directly. The requirements include:
- Proper planning for the analysis and creation of the information. The instructions of a medical device must be based on the result of market analysis and a look at the needs of the target audience. A pharmaceutical company must also analyze risk management and look at the legal agreements it has during this phase.
- General development of the IFU, including editing and testing. The writers gather information by performing usability testing and looking at information design concepts. They also decide on the content structure.
- Distribution of the information for use. How will you package and distribute the content of the IFU? Will it be electronically or physically or both?
- Improving the IFU in the future. Writing IFUs should be a regular process. Be ready to take feedback on the medical device and make adjustments to the instructions accordingly.
You don’t want to publish Instructions for Use only to realize that you accidentally left out an important detail or made a mistake in the writing process. An information management process minimizes this risk and ensures that your end user can use the medical device correctly.
EU regulations generally agree that safety instructions must be included with the product, while non-safety content can be provided separately like online. However, the legislation on medical devices is a little different.
Regulation (EU) No 207/2012, which understands that some instances may call for online instructions, specifies what circumstances or medical devices call for electronic rather than paper IFUs.
You also should look at translating your instructions too. EU Regulation calls on the languages accepted by the member states when the medical device comes out. Such a requirement extends to both the labeling and the instructions.
The Importance of Medical Device Certification
Medical devices are heavily regulated in both the United States and the European Union. The Instructions for Use specifically have their own requirements on top of the development and labeling of the device itself.
Because understanding all these regulations are paramount to increasing your compliance rate and boosting the effectiveness of your medical devices out on the field, it makes sense why pharmaceutical companies and device manufacturers are looking to give medical device training to their staff.
But where do you look for effective and up-to-date training resources from actual medical professionals? Get in touch with the industry leader in pharmaceutical, biotech, and medical device certifications. We have a training program for your specific needs.
What is required in a medical device IFU? ›
Instructions for Use (IFU) should include a detailed description of your device–including identifying the differences between your medical device and competitor products or previous versions of your own device. In addition, labeling requirements are constantly changing.Are IFUs required for medical devices? ›
Regulations for developing IFUs or “labeling” for medical devices can be found in the Code of Federal Regulations (CFR), and are specifically covered in 21 CFR 801.1–801.437. Thus, 21 CFR 801.1–801.437 are mandatory requirements.What is required on EU labeling for medical device? ›
Every manufacturer is required to incorporate the medical device symbol, which states that the product supplied to the EU market is a medical device. It is mandatory to affix this symbol on the device and all levels of packaging. In addition, the label should project the trade name and the device's original name.What is the FDA IFU for medical devices? ›
The IFU provides detailed, action-oriented, step-by-step written and visual instructions for the patient on how to use the drug including instructions on preparation, administration, handling, storage, and disposal.Is IFU part of Labelling? ›
Instructions for Use (IFU) are part of the labeling regulations.Is IFU part of labeling? ›
The FDA defines Instructions for Use (IFU) as a part of labeling, which includes all the documentation of the product, its certifications, a guide for users on how to use the product, and much more.What are instruction for use requirements? ›
Definition of “Instructions for Use”
In accordance with the Medical Device Regulation, the term “instructions for use” refers to the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken.
- Name of the device.
- Address of the manufacturer.
- Indication of medicinal substances.
- Whether or not the device is single-use or reusable.
- Preparation procedures like sterilization, assembly, or calibration.
- Intended use and contraindications.
Still, FDA does allow manufacturers to deliver eIFU rather than in paper form.What are the 7 mandatory label information? ›
These include the Product Name/ Name of the Food, Use of Brand Name and/or Trademark, Complete List of Ingredients, Net Contents and Drained Weight, Name and Address of Manufacturer, Repacker, Packer, Importer, Trader and Distributor, Lot Identification, Storage Condition, Expiry or Expiration Date), Food Allergen ...
What are EU Labelling guidelines? ›
The label must be legible, firmly secured, and accessible, and the manufacturer or the authorized representative established in the European Union is responsible for supplying the label and for the accuracy of the information contained therein. Only the information provided in the Directive needs to be supplied.How many languages must be on a label IFU for the EU? ›
To achieve this, professional users and also laypersons must be able to rely on comprehensible product information and instructions for use – a challenge with a regulation whose scope includes 24 official languages.What is the importance of IFU? ›
The IFU allows sterile processing all over the world to do our job, which is to render the medical device/instrument safe for patient use. With medical devices/instruments becoming more and more complex in design and the products used to make them require that they are processed according to the IFU.What are 3 different types of applications for medical devices submitted to the FDA? ›
- 510(k) (Premarket Notification)
- PMA (Premarket Approval)
- De Novo Classification Request.
- HDE (Humanitarian Device Exemption)
Manuals are comprehensive enough to include information that would otherwise be found in separate guides or instructions, such as usage scenarios, diagnostic procedures, installation instructions, etc. Simply put, IFU is a procedure (presumably tested procedures) used for accomplishing specific tasks.What are the 4 types of Labelling? ›
There are four major types of labels that companies and small businesses are using for their products and operations: brand labels, informative labels, descriptive labels, and grade labels.What are the 3 categories of labeling? ›
There are three kinds of labels: • Brand • Descriptive • Grade Labeling Marketing Essentials Chapter 31, Section 31.2 Page 40 The brand label * gives the brand name, trademark, or logo.What is the ISO standard for IFU? ›
Most countries have a mandatory requirement for the IFUs or Labels in their local language. To streamline this requirement, ISO 15223 standard provides a list of signs and symbols that depict common terms such as Manufacturer, Lot number, storage conditions, Expiry, eIFU and many more.Which labeling is mandatory? ›
Mandatory labelling or labeling (see spelling differences) is the requirement of consumer products to state their ingredients or components. This is done to protect people with allergies, and so that people can practice moral purchasing.What is manufacturers IFU? ›
These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device.
Who regulates medical device labeling? ›
Introduction to Medical Device Labeling
The U.S. Food and Drug Administration (FDA) develops and administers regulations under authority granted by laws passed by Congress that apply to food, drugs, cosmetics, biologics, radiation-emitting electronic products, and medical devices.
- Memory - reference instruction.
- Register - reference instruction.
- Input-Output instruction.
- Data transfer instructions.
- Data manipulation instructions.
- Program sequencing and control instructions.
- Input and output instructions.
- Direct instruction. The Direct instruction strategy is highly teacher-directed and is among the most commonly used. ...
- Indirect instruction. ...
- Independent study. ...
- Interactive instruction. ...
- Experiential Learning.
Medical devices do not require an MSDS for hazard communication as stated in 29 CFR 1910.1200.Do cosmetic devices need FDA approval? ›
Under U.S. law, cosmetic products and ingredients do not need FDA approval before they go on the market. The one exception is color additives (other than coloring materials used in coal-tar hair dyes), which must be approved for their intended use.Can you market a medical device without FDA approval? ›
In short, no. In order to market or sell a medical device, it must be registered, cleared, or approved by the FDA. In 1976, Congress amended the Federal Food, Drug, and Cosmetic Act to allow the FDA to regulate medical devices before they're legally sold in the US. This was done to ensure safety and effectiveness.What FDA regulation is required for medical device compliance? ›
The MDR regulation is a mechanism for FDA and manufacturers to identify and monitor significant adverse events involving medical devices. The goals of the regulation are to detect and correct problems in a timely manner.What are the 3 mandatory statements that must be seen on label? ›
Mandatory Labeling Elements
nutrition facts; ingredient statement (including allergen declaration); and. name and address of responsible firm.
Amounts shall be expressed to the nearest 0.5 ( 1/2) gram increment below 5 grams and to the nearest gram increment above 5 grams. If the serving contains less than 0.5 gram, the content shall be expressed as zero.
What are 5 label requirements? ›
- Sugar, fat, and sodium content.
- Calorie counts and serving size.
- A European Green Deal. Europe aims to be the first climate-neutral continent by becoming a modern, resource-efficient economy.
- A Europe fit for the digital age. ...
- An economy that works for people. ...
- A stronger Europe in the world. ...
- Promoting our European way of life. ...
- A new push for European democracy.
The common principles and values that underlie life in the EU: freedom, democracy, equality and the rule of law, promoting peace and stability.What are the new EU MDR requirements? ›
The new MDR includes a mandate for Unique Device Identification (UDI) that is intended to facilitate the traceability of all medical devices sold in the region. Devices must be marked with a device identifier (DI) and each batch or production series of the product will be marked with a production identifier (PI).What are the 3 procedural languages of the European Union? ›
The working/procedural languages of the European Commission are English, French and German.What are translation requirements for EU MDR? ›
The EU MDR puts the onus on manufacturers, rather than their member states, to comply with the translation requirements. These requirements include: -Translations must be available in all EU languages: Accompanying every device must be a translation of all required documentation in each of the 24 official EU languages.What are the minimum requirements for sample labeling? ›
- Patient name.
- Patient medical record number, with check digit.
- Patient location.
- Collection date and time.
- Specimen type and/or source.
- Test required (note any special handling required)
- Ordering physician.
Essentially all medical devices used in hospitals come with a user instruction manual, commonly called Instructions for Use (IFU) or Directions for Use.Why it is important to follow the recommendations and instructions of the manufacturer? ›
Manufacturer instructions provide us with technical information that can help form a risk assessment, that will then allow us to develop suitable controls and wear protective equipment to protect us against the hazards associated to a machine or equipment.What is the purpose of the current regulatory standards for medical devices equipment and materials? ›
These regulations fall under the Consumer Protection Act 1987 and ensure medical devices meet the requirements so that they are acceptably safe to use and suitable for their intended purpose.
What are the two types of control placed on medical devices by FDA? ›
The regulatory controls for each device class include: Class I (low to moderate risk): general controls. Class II (moderate to high risk): general controls and Special Controls.What are the 4 phases of FDA approval? ›
- Step 1: Discovery and Development.
- Step 2: Preclinical Research.
- Step 3: Clinical Research.
- Step 4: FDA Drug Review.
- Step 5: FDA Post-Market Drug Safety Monitoring.
3 Basic Pathways to Medical Device Approval. There are 3 basic processes to obtain FDA marketing approval for medical devices, depending on the nature of the device and the circumstances under which approval is sought: 1) the PMA process; 2) the PMN process; and 3) the humanitarian device exemption (HDE) process.What are the regulatory requirements for medical devices? ›
The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval.Is an IFU the same as a user manual? ›
Summarizing it, operation manuals focus on how to operate a medical device, while IFU focuses on instructions for performing tasks on a medical device.How are medical devices regulated in the US and EU? ›
In US Medical Devices are regulated by FDA- Centre for Devices & Radiological Health, in EU they are regulated by European Medical Agency, in China they are regulated by State Food & Drug Administration and in India they are regulated by Central Drug Standard Control Organization.What is EU MDR compliance? ›
What is EU MDR Compliance? EU MDR compliance is accomplished by demonstrating conformity with all relevant aspects of the Medical Device Regulation (EU) 2017/745. Manufacturers will need to demonstrate compliance in order to gain regulatory approval of their medical devices.