IFU For Medical Devices: What US & EU Companies Must Know

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.

Labeling

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.

Special Cases

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.

Harmonized Standards

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.

Other Considerations

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.