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Classification in FDA Vs EU

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(@merzkrashed)
Posts: 123
Estimable Member
Topic starter
 

Hi All,
As Dr.Simon mentioned about classification in EU is based on risk, Higher risk = higher classification, and
Essential Requirements Checklist helps determine classification.
In the US, the FDA determines the device class using medical specialty panels, safety and efficacy. Life sustaining devices are automatically Class III…. Not so in the EU.

Can you give us an example for any medical device that classified in US and EU, is there any difference?
For Example:
Device: Blood Pressure Cuff
Definition:
A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve(cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.
Regulation Medical Specialty:Cardiovascular
Class:II

In EU:
Blood pressure cuff
• Invasive or non-invasive: non-invasive
– Doesn’t channel or store fluids for eventual infusion
– Doesn’t modify blood or other body fluids
– Doesn’t come into contact with injured skin
• Not an active device
• No special rules apply
• Class: I by Rule 1

Hint use this link:
FDA:accessdata.fda.gov
EU:ec.europa.eu/commission

 
Posted : 23/01/2018 10:16 am
(@srg36)
Posts: 117
Estimable Member
 

Orthopedic devices such as hip and knee implants are classified in both the US and EU. In the US these devices are considered class II, but I did a little research about how these devices are classified in the EU, and what I found was surprising to me. In 2007 Directive 2005/50/EC was released about the reclassification of hip, shoulder and knee devices. This directive altered the classification of those devices from Class IIb to Class III, giving the following reasons for this reclassification: the hip, knee, and shoulder are complex joints, the hip and knee are weight bearing joints, the hip and knee are extremely sophisticated implants, shoulder implants are a more recent technique, and hip, knee, and shoulder replacement surgery is increasing in younger patients. I found this very interesting, because I expected the classification to be similar or slightly lower in the EU as compared to the FDA, but actually, the EU places these devices in the highest risk class.

 
Posted : 24/01/2018 4:03 am
(@srg36)
Posts: 117
Estimable Member
 

I cannot post the link to the article where I found this information because I keep getting an error. However, the website was called Emergo Group.

 
Posted : 24/01/2018 4:06 am
 Josh
(@orleron)
Posts: 95
Trusted Member Admin
 

Yes, good catch on the joint implants. They are a higher class in the EU than the US. The impression in general is that EU classifications are somehow less strict or easier or lower, and that's not actually true in modern times. As you can see with the joints, it's often the reverse.

Another example: in the EU any device with a new biomaterial is automatically Class III, even if other devices that do the same thing are a lower class. In the US you could get a good regulatory person to pass that off as a Class II in many cases.

Spiral Medical Development
www.spiralmeddev.com

 
Posted : 25/01/2018 5:37 am
(@reshamn)
Posts: 67
Trusted Member
 

I was able to find one example of where the classification of a device was different in the EU vs the US. Contraceptives such as a female condom is classified as a Class III device in the US where as in the EU it is classified as Class II. This is surprising since there have been many petitions to classify female condoms as Class II, similar to the male condoms in the US. This unfair and unnecessary labeling variation makes it harder for manufacturers to get new types of female condoms approved for sale in the United States, and ultimately harms women’s health. Right now, women in the U.S. can only buy the FC2 female condom, but there are other types available internationally like in EU.

 
Posted : 26/01/2018 8:45 am
(@alexandrabuga)
Posts: 149
Estimable Member
 

Like @srg36, I found the 2005/50/EC directive about the reclassification of hip, shoulder and knee devices from Class IIb to Class III. I also found that in EU All implantable devices and long-term surgically invasive devices are in Class IIb unless they are intended: to be placed in the teeth, in which case they are in Class IIa, - to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are Class III,to have a biological effect or to be wholly or mainly absorbed, in which case they are in Class III, or to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines, in which case they are in Class III and that there was Directive 2003/12/EC introduced a derogation from this rule, reclassifying breast implants in Class III.

Breast implants were reclassified by the FDA from Class II to Class III device, and I was curious to know which regulatory body made the reclassification first. As one would expect, the Directive 2003/12/EC by the EU was put in place in 2003. I was surprised to find that the FDA made the reclassification for breast implants from Class II to Class III in 1988. From the FDA website: In response to emerging safety concerns, the FDA re-classified breast implants to class III devices (requiring premarket approval). However, in accordance with the law, they continued to be reviewed through the 510(k) process until the FDA issued a rule calling for submission of premarket approval applications (PMAs).

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm064461.htm

http://ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_4_1_rev_9_classification_en.pdf

 
Posted : 28/01/2018 7:58 am
(@bb254)
Posts: 113
Estimable Member
 

I work for a cardiovascular company that deals with an FDA classified class II medical device that is sold internationally, specifically Europe. A cardiovascular medical device that I love learning about it the pacemaker. A pacemaker is considered in the EU as an Active Implant Medical Device. It is composed of an electrical circuit which stays within the body after surgery. Both the EU and FDA classify a pacemaker as a class III device. The EU justifies this classification based on the essential requirements checklist and risk evaluation. The FDA determines the classification based on safety, efficacy and risk. Both the EU and FDA require clinical trials for supporting data in approving the active implant device. The FDA requires a PMA to be completed for the approval of a pacemaker. EU asks for a tech Dossier File for class III devices.
References:
http://ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_4_1_rev_9_classification_en.pdf
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=NKE

 
Posted : 28/01/2018 11:35 am
(@hm243)
Posts: 85
Trusted Member
 

The classification of a device is determined by the risk of the device. If the device in question for classification has a higher risk, it is likely to have a higher classification. However, many device classifications differ between the EU and US. For example, the device class for the urinary catheter is not the same in both areas. A urinary catheter is placed in the bladder through the urethra so a patient will be able to release their urine easily. In the EU, the urinary catheter is classified as a Class 1 device if used for transient use. In the US, however, the urinary catheter is classified as a Class 2 device. The higher classification in the US shows that there is a higher risk considered in the US for the device.

http://ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_4_1_rev_9_classification_en.pdf

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=1676

 
Posted : 28/01/2018 12:07 pm
(@kak33)
Posts: 58
Trusted Member
 

There are differences in regulatory approach between the EU and the U.S.. Therefore; there are differences in device classification and we can not assume that meeting the requirements for the U.S. market would satisfy the EU requirements. Another example of a medical device that is classified in US and EU differently is hospital beds. According to FDA guidance, hospital beds including accessories are either Class I or II depending on the type of bed. In the EU, hospital beds and accessories are classified as Class I devices, allowing self-certification. In addition, the beds and their accessories would have to be considered separately, each as medical devices in their own right, especially when such items are sold separately.

 
Posted : 28/01/2018 3:07 pm
(@thuytienlecao)
Posts: 72
Trusted Member
 

I would add on to the list of various devices being classification differently between the US and EU with needle destruction devices. These are not considered medical devices in Europe but they are class III in the United States. In Europe, these devices go through electrical safety and electromagnetic compatibility and compliance to the European low voltage and other electromagnetic compatibility directives. However, in the US, these devices need PMA, clinical trials etc before entering the market.

Another example is dental splints (preventing teeth grinding). As is, these devices are class I in both the US and EU. But if the manufacturer claim that the devices also prevents migranes, they would be considered as class III devices in the US and class I in Europe.

Reference: "Is my product a medical device?" (Emergogroup)

 
Posted : 28/01/2018 3:54 pm
(@savery115)
Posts: 82
Trusted Member
 

In the US, nonabsorbable sutures can be classified as Class II with moderate risk of injury. In addition, absorbable sutures can be classified as Class II. In EU it is considered Class IIb medium to high risk if it is nonabsorable. However, if it is absorbable it is considered Class III. Essentially, the sutures classification is based on the structure of the suture. For Class II sutures they are made up of cotton or linen fibers or coated natural or synthetic fibers in which the coating contributes to suture thickness without adding strength. For Class III sutures they are made up of metal wire of monofilament or multifilament construction.

 
Posted : 28/01/2018 6:22 pm
(@monicagoncalves)
Posts: 59
Trusted Member
 

Medical Device: Mitral Clip
Definition: Mitral Clip is used to is reduce mitral regurgitation (MR ≥ 3+) due to a primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery.
FDA: Class II
EU: Class III

 
Posted : 28/01/2018 6:47 pm
(@dipanpatel)
Posts: 71
Trusted Member
 

The one big difference in classification I see between the FDA and the EMA is the class II classification. In the US, around 25 percent of the class II devices do not go through a clinical trial, whereas the other 75 percent do. This is due to the evaluation of the actual risk of the product and the intended use. The EMA uses a scale of Class IIa and Class IIb to differentiate the between the two type of class 2 devices. This I believe is a better way to provide a ranking. Another key difference was the use of the work efficacy in the literature. This is a very important part of any device and it's interesting the see the difference in roles of the two governing bodies, even though both bodies are effective, the EMA seems to have more of a checklist sort of regulation. Which can be faster and cheaper to go through then the FDA. Which explains the inclination of companies to used the data from EMA trials to support FDA approval.

 
Posted : 28/01/2018 6:53 pm
(@santase)
Posts: 18
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Posted : 16/04/2018 4:07 pm
(@alexandrabuga)
Posts: 149
Estimable Member
 

There's a new EU Medical Device Regulation (MDR) that will be effective in 2020

This article goes into the "6 Things You Need to Do to Prepare for the New EU Medical Devices Regulation":
1. Plan Ahead
2. Conduct a Thorough Review
3. Invest Time and Resources
4. Start Small
5. Adopt Early
6. Address Reclassification if Necessary

"Under the new EU regulatory approach, there will be no grandfathering of legacy or pre-MDR devices. This means that by the end of the transition process, every CE marked device must by fully compliant with the MDR. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has estimated that more than half a million different devices currently CE marked under the MDD must transition to fully comply with the MDR."

https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2017/6/6-things-you-need-to-do-to-prepare-for-the-new-eu-medical-devices-regulation
It will be interesting to see how this new MDR regulation will play out. It should be interesting what large international companies do in the next few years.

 
Posted : 06/05/2018 12:06 pm
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