Medical device certification has to remain somewhere at the top of entrepreneurs’ priority lists in the Medtech industry. It’s a clearance to move your product from a workshop to the public. What is the difference between a class 1 and class 2 medical device? What you should know about medical devices classification to better understand the process?
Paweł Zieliński – Marketing Manager Consonance
How Medical Devices are Classified
Depending on how your product is categorized by the regulatory bodies, different restrictions may apply to your medical device. Each regulatory body has established a number of distinct categories for medical devices. If you’re reading this I think you’ve already bumped into terms like FDA or MDR.
Categories (medical device classification) relate to the perceived risk of the product category.
Makers of medical devices that sell globally need to become familiar with the rules that apply in those areas. This can be difficult for most manufacturers to do and is easier said than done. While following one set of regulations, the US, Canada, and Europe all adhere to others.
Fortunately for the Medtech industry, there are significant similarities between global laws and standards governing medical devices. What I’d like to focus more on is classification established through EU MDR 2017/745 by the European Commission (EC).
It is important to understand how your medical equipment is categorized for the following reasons:
- How your product is classified will affect what steps you need to take before selling it.
- You may set requirements, particularly design controls, throughout the product development phase with the use of product classification.
- Product categorization is a crucial factor in figuring out how much it will cost and how long it will take to get your gadget on the market.
MDR risk class system
Getting a CE marking is the first step in marketing in Europe. The criteria for obtaining CE certification are determined by the EU categorization of your medical equipment. The details required to identify your device class are included in the medical device regulation (EU MDR) of the European Union.
You must ascertain if your medical device:
- Non-Invasive – any device that does not enter the body by a hole or through the skin. Although these devices are normally Class I, some regulations and exceptions may apply, making them Class II or higher.
- Invasive – any instrument that enters the body entirely or partially, either by a bodily orifice or through the surface of the body, is considered to be invasive.
- Active – any device whose function depends on an energy source other than that produced by gravity or by the human body and which operates by altering the density of that energy.
There are specific guidelines that apply for each of the major categories and are listed in Annex VIII of the new medical device legislation. Determining categorization is rather simple when these criteria are taken into account, together with the time frame for use.
For instance, a device used continuously for less than 60 minutes is regarded as transitory duration, from 60 minutes to 30 days as short-term, and longer than 30 days as long-term.
The United States and the European Union both use the same approach for classifying products:
- Class I – Non-sterile or no measuring function (low risk)
- Class I – Sterile and a measuring function (low/medium risk)
- Class IIa (medium risk)
- Class IIb (medium/high risk)
- Class III (high risk)
Before being sold in the European Union, all medical devices must first receive a CE label, which involves comprehensive technical paperwork. All classes of medical devices in the EU, with the exception of Class I devices that can be self-certified, need collaboration with a Notified Body.
In order to handle product registration in Europe, businesses must engage with an authorized representative.
Class I Devices
Equipment that provide a low to moderate danger to the patient and/or user are classified as Class I medical devices. Today, 95% of medical devices fall into this group, which accounts for 47% of all devices and is free from regulation. An application for premarket notice must be submitted if a gadget fits within a general group of exempted Class I devices.
Class IIa Devices
The MDR classifies Class IIa medical devices as medium-risk devices. In contrast to a Class I item, the manufacturer must now wait for a notified body to provide a declaration of conformity following its conformity evaluation. Catheters, hearing aids, and temporary contact lenses are a few examples of this risk category.
Class IIb Devices
Class IIb medical devices are categorized as medium- to high-risk devices under the MDR, hence a notified body is also necessary for their CE route. Devices in this danger category include ventilators, insulin pen, long-term contact lenses, and incubators.
Class III Devices
Class III devices are regarded as high-risk and are subject to the strictest regulations, including the device’s clinical evaluation.
Devices like pacemakers, artificial heart valves, surgical mesh, breast implants, and other items that must be continuously monitored throughout the course of their lifespan fall under this risk category. This class represents up to 10% of regulated products.
If you want to know more, listen to the latest episode of podcast Medtech NOW!
Are you about to start your new Medtech endeavor? Is getting a certificate for a medical innovation that hard or expensive? We discussed with Kinga Kierepka, Head of Quality Assurance at Consonance about QMS, ISO 13485, CE mark, timeline, costs, device classification and more.
Medical Device Classification rules
The key is risk. The dangers related to each medical equipment are used to categorize them. The level of regulatory control increases with class number, further defining the regulatory standards for a generic equipment type. The intended purpose of the device and any specific indications for its usage, in addition to the danger the device poses to the patient and/or the user, are used to classify it.
Determining your device classification for Europe
The risk class of a medical device is determined by the EU using a rules-based methodology. There are 22 rules for categorizing any medical equipment in Annex VIII of the MDR. The regulations are broken down into four sections, and each section’s regulations only apply to a certain class of devices.
- Non-invasive devices are covered by Rules 1-4.
- Invasive devices are covered by Rules 5-8.
- Active devices are covered under Rules 9–13.
- Nanomaterials and other devices that don’t fit within the first three categories are covered by special regulations 14–22.
The duration of the device’s use is also taken into consideration when deciding whether rules within a category apply. The three durations that are listed in the MDR are:
- Temporary: Intended to be used continuously for no more than 60 minutes
- Short Term: Intended for continuous usage for up to 30 days, but no more than 60 minutes.
- Long Term: Intended for usage for a period of time longer than 30 days.
Getting your device certified can be difficult and usually requires investments. Because there is a possibility to fail with a device clearance, a reasonable choice is to hire a company which offers medical devices regulatory consulting services. Their purpose is to guide you through the entire process and provide you expertise which raises the maximum chances of speeding up the time-to-market process.