Medical device manufacturers who are manufacturing and marketing their products in Europe have to comply with EU MDR requirements. These requirements apply to all medical device manufacturers, and they can use harmonized standards for proving their compliance with the essential requirements of EU MDR.
Types of Harmonized Standards
There are two types of harmonized standards that medical device manufacturers can apply to comply with European legislation requirements. A medical device manufacturer can verify that any harmonized standards are based upon his device’s type. By doing this, he can determine the requirements of IFU for his medical device.
The two different types of harmonized standards are:
- Vertical Standards
- Horizontal Standards
Vertical Standard is also known as C-type standard. It provides specifications for a specific category of the device.
Application of Vertical Standard
The Vertical Standard or C-type standard includes all categories of medical devices such as
- X-ray Equipment
- Surgical Luminaries
- Radiotherapy simulators
Vertical Standard may contain additional or more detailed requirements for Instructions for Use based upon the type of the device.
In contrast to Vertical Standards, Horizontal Standards apply to all product groups, for example
- Medical devices
- PPE (Personal Protective Equipment)
Horizontal Standard for IFU
Previously, ISO IEC 82709-1:2012 was used as the Horizontal Standard for IFU. It has now been replaced by IEC/IEEE 82079-1:2019.
Difference between EU MDR & IEC/IEEE 82079-1 in Terms of Generality
EU MDR is general in its dialect, whereas IEC/IEEE 82709-1 is more specific. For example, EU MDR tells the manufacturers
“The information and instructions provided by the manufacturer shall be easy for the layperson to understand and apply.”
The standard does not specify the type of information it requires from manufacturers. In contrast to it, IEC/IEEE 82709-1 states the requirements explicitly which it requires from the manufacturers of medical devices.
An example of this can be seen where it instructs medical device manufacturers to make their instructions more understandable for a layperson by doing the following:
Applying the Principles of Minimalism
A manufacturer should apply principles of minimalism while presenting the information to a layperson.
Provision of Relevant and Usable Information
IFU for laypersons shall be usable and relevant to the target audience’s respective goals and tasks.
Use of Consistent Terminology
The medical device manufacturer should use consistent terminology throughout his IFU. This will make the IFU more comprehensible for his audience.
Use of Clear Signs, Fonts, & Graphic Symbols
In order to make IFU more presentable, the manufacturer should use those graphic symbols, fonts, and signs that are clear to the users of medical devices.
Assigning IFU Creation to Competent Persons
The manufacturer should make it the responsibility of able and competent persons to prepare IFU for his medical devices.
Having a sound knowledge of EU MDR requirements and both vertical and horizontal standards is important for a medical device manufacturer. This will help him harmonize all the requirements of EU MDR and horizontal and vertical standards.
Looking Forward to Harmonized Standards for your IFUs?
Alysidia has established itself as one of the most competent information technology service providers in Europe. With our professional expertise, we empower medical device manufacturers across Europe by providing them with quality electronic IFUs. If you are a medical device manufacturer who is looking forward to getting electronic IFUs and getting harmonized with the requirements of EU MDR and IEC/IEEE 82079-1, Contact us today or email us at firstname.lastname@example.org.