E B OOK
A STEP-BY-STEP
GUIDE TO
DETERMINE HOW
YOUR MEDICAL
DEVICE WILL
BE CLASSIFIED
JO N S P EER ,
FO U N DE R & V P OF QA /RA GREEN L IG HT.G URU
A STEP-BY-STEP GUIDE TO DETERMINE HOW YOUR MEDICAL DEVICE WILL BE CLASSIFIED PAGE 1
A STEP-BY-STEP
GUIDE TO DETERMINE
HOW YOUR MEDICAL
DEVICE WILL BE
CLASSIFIED
TABLE OF CONTE N TS
3. Regulatory Classification 101
5. Medical Device Regulatory Classification
11. Medical Device Classification in Europe
13. Medical Device Classification in Canada
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A STEP-BY-STEP GUIDE TO DETERMINE HOW YOUR MEDICAL DEVICE WILL BE CLASSIFIED PAGE 2
A STEP-BY-STEP GUIDE TO
DETERMINE HOW YOUR MEDICAL
DEVICE WILL BE CLASSIFIED
What I am about to share with you is a guide to medical device regulatory
classification.
In this guide, I will provide you with a step-by-step approach for determining
how your medical device will be classified by U.S. FDA, European Commission,
and Health Canada.
Getting a basic understanding of regulatory product classification will be
invaluable to your efforts to bring new products to market.
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REGULATORY CLASSIFICATION 101
Basically, every medical device is regulated in some way by regulatory agencies,
such as FDA, European Commission, and Health Canada. These regulatory
agencies have defined a bunch of rules and regulations (or “laws”) regarding
medical devices.
The rules that apply to your medical device depend on how your product
is classified by the regulatory agencies. Each regulatory agency has defined
several different classifications for medical devices.
The classifications are, for the most part or as a general rule, related
to the perceived risk of the product type.
I know. Clear as mud.
Yes, I can imagine what you might be thinking.
U.S. has one way.
Canada has another way.
Europe another way yet still.
And the rest of the world?
To some extent, you are correct. And fortunately, too, there are quite
a bit of similarities when it comes to medical device classification.
When you start to explore how your medical device product idea will be
regulated, it can be a little discouraging and overwhelming.
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WHY DOES REGULATORY CLASSIFICATION EVEN MATTER?
Knowing how your medical device is classified matters for the following reasons:
1. Product classification will determine what you have to do BEFORE
you can sell your product.
2. Product classification will help you establish what is required during
product development and Design Controls.
3. Product classification is an important component in determining how
much it will cost to bring your product to market and give you some
idea of how long it will take.
Because of this, I’m going to provide you with a little bit of guidance to better
understand what to do and how to do it.
Note, the information I’m about to provide is intended to help educate you on
medical device regulatory classification and what is required for your medical device.
This following content is not a comprehensive guide to regulatory submissions,
yet should give you some basic guidance and direction on identifying how
to establish path to market.
I’ll stick to the “big 3”: U.S., Europe, and Canada.
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MEDICAL DEVICE REGULATORY
CLASSIFICATION
PrintIn the United States, medical devices
are regulated by Food & Drug Administration,
of FDA. The specific branch within FDA is Center
for Devices & Radiological Health (CDRH).
The mission of CDRH is to protect and promote public health. In other words,
ensure medical devices are safe.
In the U.S., medical devices are either Class I, Class II, or Class III. The FDA CDRH
classification is based primarily on risk the medical device poses.
Class I are generally deemed low risk and Class III highest risk. The types
of controls required is dependent on your product’s classification.
Classification is directly related to intended use and indications for use.
The distinction between this terms is a bit confusing.
Intended Use is the general purpose of the medical device or its function
(what you “claim” the medical device does)
Indications for Use describe the disease or condition the medical device
will diagnose, treat, prevent, cure, or mitigate, including a description
of the target patient population
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A STEP-BY-STEP GUIDE TO DETERMINE HOW YOUR MEDICAL DEVICE WILL BE CLASSIFIED PAGE 6
Keep this in mind. The intended use and indications for use of your medical
device express the reason why you had this idea for a new medical device.
FINDING THE APPLICABLE FDA REGULATIONS
FOR YOUR MEDICAL DEVICE
Once you define intended use and indications for use, now you need to find the
possible regulations and product codes. Tracking down regulatory classification
for your product via FDA takes a little bit of time and perseverance.
Without boring you with too many details, FDA has established several general
categories based on the medical specialty: CFR 21 Parts 862 to 892.
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When you find the possible categories and click on the FDA regulation number,
the list of possibilities suddenly seems endless. Here is a partial view of the
options for “870 Cardiovascular devices”:
This can be frustrating and overwhelming.
When you find a regulation that appears to be a possible fit, you can click
on the link and get more details to make a determination.
For example, if I think my device fits in “870.1250 Percutaneous catheter,”
I click the link and get this information:
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The details provided give me some idea if my intended use and indications
for use align with this specific regulation.
I also discover the FDA device classification.
In this example, I learn that my product is Class II (performance standards),
which means I will need to submit a 510(k) to FDA prior to getting market
clearance.
(I share more about types of FDA submissions further on in this guide.)
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NEXT – FIND THE APPLICABLE PRODUCT CODES
Finding the applicable regulation for you medical device and classification
is the first part. Now you need to find the applicable product codes.
Here’s how:
Go to the FDA Product Classification Database and type in the regulations
number you found. If you find more than one possibility, then you will need
to repeat this process for each.
When you click “search”, you will get a list of possible product codes.
You can then review each individual code to determine the best option
for your product by clicking on each code.
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DETERMINING YOUR FDA PATH TO MARKET
Knowing the applicable regulation and product code (as described above)
is necessary for you to determine the classification of your medical device.
Once you have this information, you will now be able to determine the “path”
to get your product registered with FDA.
Here are the options:
• Class I (low to moderate risk): general controls
• Class II (moderate to high risk): general controls and Special Controls
• Class III (high risk): general controls and Premarket Approval (PMA)
Let me boil it down to this.
If you find your product is “exempt,” then only general controls apply and
no formal FDA submission is required. You do, however, need to register your
establishment with FDA and then list the product.
If you find your product requires special controls, this means you will have
to prepare a 510(k) submission to FDA and receive clearance before going
to market. And then need to register your establishment and list the product.
If you find your product requires premarket approval, this means you will have
to follow the FDA PMA process to receive approval before going to market.
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MEDICAL DEVICE CLASSIFICATION
IN EUROPE
The regulations for a medical device in EU
are established through the Medical Device
Directives by the European Commission.
The path to market in Europe is to obtain
a CE mark.
To figure out what is required to CE mark your medical device, you first must
determine the EU classification per Annex IX in the Medical Device Directive
(93/42/EEC as modified by 2007/47/EC).
Fortunately, there is a pretty easy to follow guidance document to determine
medical device classification in EU.
You will need to determine if your medical device is:
• Non-Invasive
• Invasive
• Active
For each of the broad categories, there are certain rules which apply. These
categories coupled with the duration for use make determining classification
fairly straightforward.
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Let’s consider the percutaneous catheter example used earlier when discussing
FDA classification.
I determine my medical device fits into the “invasive” category, narrowing my
search down to rules 5, 6, 7, and 8. I narrow the rules down further because
my medical device is short-term because it is used for a period greater than 24
hours and less than 30 days.
I determine rule 7 is the best fit.
My percutaneous catheter will administer medicines, making my product a Class
IIb medical device in Europe.
DETERMINING YOUR EU PATH TO MARKET
EU has a similar product classification system as the U.S.
• Class I
• Class IIa
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• Class IIb
• Class III
In all cases, a CE mark technical file is required. I suggest following a guidance
document to help you with putting the technical file together.
All EU medical device classes require working with a Notified Body except for Class I.
You will also need to work with an Authorized Representative to take care
of product registration in Europe.
MEDICAL DEVICE CLASSIFICATION
IN CANADA
The medical devices regulations in Canada
are established by the Government of Canada
and regulated by Health Canada.
Like the U.S. and EU, you first must determine
the medical device classification for Canada.
Like EU, Canada has a pretty easy to follow guidance document and it’s very
similar to Europe..
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Like EU, you will need to determine if your medical device is:
• Non-Invasive
• Invasive
• Active
For each of the broad categories, there are certain rules which apply.
These categories coupled with the duration for use make determining
classification fairly straightforward.
I’ll use the percutaneous catheter example again.
I determine my medical device fits into the “invasive” category, narrowing
my search down to rules 1, 2, and 3. After reviewing the options, I determine
that rule 1 applies.
Click to see the full infographic on the next page
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Based on my intended use, my medical device is Class II in Canada.
DETERMINING YOUR CANADA PATH TO MARKET
Medical device product classification in Canada is similar but different from EU
and U.S.
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A STEP-BY-STEP GUIDE TO DETERMINE HOW YOUR MEDICAL DEVICE WILL BE CLASSIFIED PAGE 16
• Class I
• Class II
• Class III
• Class IV
Prior to going to market in Canada, you must apply for a medical device license.
A license is not required for Class I medical devices. This Health Canada
guidance walks you through the process. Class III and Class IV medical devices
also require summary technical documentation (STED).
You will also need to obtain ISO 13485 certification with CMDCAS (Canadian
Medical Device Conformity Assessment System).
A STEP-BY-STEP GUIDE TO DETERMINE HOW YOUR MEDICAL DEVICE WILL BE CLASSIFIED PAGE 17
A STEP-BY-STEP
GUIDE TO DETERMINE
HOW YOUR MEDICAL
DEVICE WILL BE
CLASSIFIED
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