The instructions for use (IFU) pertaining to medical devices substantially differ between the Medical Device Regulation (MDR) and the Medical Devices Directive (MDD). Despite the distinction, however, their IFU should demonstrate an economic operator’s (EO) conformity with technical requirements to ensure medical devices in the market are safe to use. We explained IFU requirements in detail in this post.
All European Economic Area (EEA) member nations are bound by the same regulations, but each state is allowed to adapt how a directive will be integrated into its national legislation so long as the same outcomes are attained.
In the Netherlands, for example, labels and directions for usage must be stated in Dutch. As such, the MDR contains Article 6 (2), “Besluit medische hulpmiddelen.”
According to the MDR, a Notified Body must be involved in evaluating Class IIa, IIb, and III medical devices. Part of the compliance evaluation is the inclusion of an IFU, which must be verified not just for completeness but also accuracy.
There are, however, exceptions. Some Class I and IIa devices may drop IFU as a requirement if they are easy to use.
IFU Regulation Differences between the MDR and the MDD
The EU importer accords greater importance to consumer safety and security than the MDD. As such, the MDR reclassified certain medical and in vitro diagnostic devices into higher risk classes than the MDD.
Given that, EOs must revisit and reevaluate their quality assurance, risk management, and post market expectations to stay abreast of the changes made because compliance to the MDR is a must.
Things to Consider When Writing an MDR-Compliant IFU
IFU are meant for the consumption of users with varying comprehension levels. Chapter III of the MDR requires the following:
- Trade name, registered trademark, and address
- Dates of issue or revision dates
- Incorporated substances (human blood, plasma, tissues or cells of animal or human origin)
- Device sterility, qualitative composition, and quantitative information
- Intended use and contra-indications
- Training requirements and proper use
- Correct installation, storage, handling (maintenance, calibration, preparation)
- Clinical benefits
- Associated risks and security measures
- Safe disposal
- Local authority to report incidents
Soft or Hard Copy, Which Is Better for an IFU?
All EU member countries require any kind of product to come with safety instructions at the least. Further instructions can be offered online. In fact, EU Regulation No. 207/2012 states that “for some medical devices, the supply of instructions for use in electronic form rather than in paper form can be helpful for professional users.”
What matters most when providing IFU, regardless of format, is that it provides explicit and accurate instructions after the concerned device undergoes extensive risk analysis.
When Should You Make Modify and Update a Medical Device’s IFU?
Changes made to IFU differ in purpose. Some are done to include information and instructions for new features. Others are made to revamp old, or possibly incorrect, instructions. Regardless of the modification’s purpose, it must be done in a timely manner—at the same time the medical device is released.
Although IFU are not considered legal documents, they are required to keep all medical device users and their patients safe.
More Information? GrowthImports
We provide non-EU medical and in-vitro device manufacturers with independent European-wide importing services compliant with Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) requirements.
Import your medical goods Into Europe with our hassle-free market access Importing service while maintaining flexibility, compliance and Increased quality standards.
With over 30 years of combined experience, GrowthImports is dedicated to ensure the facilitation of a compliant and smooth international MDR/IVDR compliant importing process in the European market.
Boompjes 5 | 7607 HE Almelo
T: +31 85 13 08 966