It is highly important that the medical devices must be tested properly and proved safe!
The European Union (EU MDR) classification will bring you all about the classification of medical devices and this blog presents how it is being classified. This is not in accordance with the MDD 93/42/EC classification rather the “new one” EU medical device regulation 2017/745 or EU MDR 2017/745 and this seems to be mandatory from 2020 onwards. Also it is noticed that the status period is extended. Global quality services bring you this blog to make you aware of the classes of medical devices.
Number of classification that exists:
The EU MDR 2017/745 has categorized the medical devices into four main divisions and they include,
- Class I
- Class IIa
- Class IIb
- Class III
The products or the devices with the low risk will be put into class I and the products with higher risk stages are into class III. In order to be more specific, these main 4 divisions are further splitted into sub categories like class ls, class lm, and class lr.
Class ls: This comprises the class I products that are delivered as ‘sterile’
Class lm: This comprises the products or devices that are with a measuring function
Class lr: This is a new sub class that is mentioned for products that are reprocessed
Factors taken into account for classification:
Some of the factors that are being considered to undertake this classification include:
- The duration by which the device is going to be used
- Ensuring if the device is surgically invasive or not
- Ensuring that the device is actively used or surgically implantable
- If any medical substances are present in the device
Class I devices:
The medical devices those are considered to be the ‘lowest risk level’ comes under the class I classification. This complies only the lowest level of regulatory standards. In an overall analysis, 47% percent of the medical devices will fall under this category. And the remaining 95% of the medical devices will be an exemption from the regulatory processes. If any of the devices is identified to be in the general category of exempted class I devices, then the premarket notification and FDA clearance is not mandatorily required. The examples of class I devices include elastic bandages, dental floss, enema kits, manual stethoscopes and bedpans.
Class II devices:
The devices or products that come under class II medical devices are the ones that come under the moderate to high risk to the patient or the user. Here in this category 43% of the medical devices will fall, and it is found that almost many of the medical devices fall into this category. They are more complicated than the class I devices and hence require stringent regulatory controls in order to provide the assurance and safety of the user. Examples of these devices include condoms, pregnancy testing kits, and powered wheelchairs.
Class III devices:
The class III devices are said to be the most complex devices and these are also considered to follow the more stringent regulatory controls. Some of the devices include implantable pacemakers and breast implants. These represent only 10% of the medical devices.
Based on the duration of use, the medical devices can be categorized into ‘Transient’, ‘short term’, and ‘long term’.
You need to keep track of your product’s life cycle and every device manufacturer must keep quality in the first place. Global quality services help you to track all the quality and the legacy approach along with the regulations.
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