Why dose classification of medical device matter
The classification of medical device is defined mainly according to risk to users. For example:
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The duration of medical device contact with the body.
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The degree of invasiveness.
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Whether the medical device delivers medicinal products or energy to the patient.
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Whether they are intended to have a biological effect on the patient.
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Local versus systemic effects
The higher risk the products bear, the higher class they belong.
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There are markets as EU and Australia with 4 classes: I, IIa, IIb and III
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There are markets as China and US with 3 classes: I, II and III.
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Japan, Canada and Brazil have 4 classes of medical device, I, II, III and IV.
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There are markets as Singapore and Malaysia with 3 classes: A, B, C, and D.
How to classify a medical device
In EU using the classification rule manufacturer has to match all classification rules, the highest matched is final classification.
In US and China, manufacturer matches with intended use to product code. Determined product code, the classification is given.
EU
The strictest rule and sub-rule resulting in the highest classification determines the class. There are in general I, IIa, IIb an III medical devices. Applicable classification guidance is MDCG 2021-24, “Guidance on classification of medical devices”.
Unique: In EU there are even Is (sterile), Im (measure) and Ir (reuse) class.
US
In general the classification in US is down classified compared to EU. The key is to match to definition of respective product code in classification database. The main products are class II with 510k. The class III MD is often undergone to PMA with extensive technical documentation. Manufacturer needs just to list class I medical device without review.
China
There is product code system to match intended use at classification catalogue with mean 22 product categories. There are class I, II and III medical devices.
Trend: In general is MD in China at the beginning or regulation higher classified. However authority reclassifies annually the classification, trend is down classification!
Singapore
In Singapore besides guidance on the risk classification of general medical devices, there is special medical devices product classification guide in presentation making example what is medical device and non-medical device. There are A, B, C and D medical devices. The system of classification rules is very similar to European MDR.
Try it yourself: They have a browser based Medical device risk classification tool
What to do otherwise
In case that manufacturer can not find classification of medical device, He can apply for determination of classification in CA or NB. Another option is to find classification of similar products in product database.
Why classification matters
The classification is related to clinical evidence, involvement of review of CA or NB, implement of UDI (sooner or later), quality management system and many diverse post market surveillances. Normally the lowest class I or A medical device is waived by most requirement except in EU and at least latest impacted.
Pathway of registration
Taken US as example, with product code you can find regulation number, submission type GMP exempt guidance and recognized Consensus Standards.
In China knowing class and product code you can find guidance, standards, req of TD, clinical evidence (evaluation and trial).
Post market requirement
This is high demanded in EU. For higher-risk devices (above class IIa) manufacturers must compile a Periodic Safety Update Report (PSUR) and Post-Market Clinical Follow-up (PMCF). Summary of Safety and Clinical Performance (SSCP) is required for Class III and implantable devices, providing transparent public access to essential clinical and safety data.
In contrast, Class I devices typically only require a Post-Market Surveillance Plan and reports, without mandatory PSUR or PMCF unless risk justifies it.
Search of distributor
How to classify medical device is a task for regulatory affairs manager. The other stakeholders as sales-, product manager may search how market entry of competitors is. Using database of medical device with product code (classification) you can know the newest approval of similar products.
Classification intelligence
Whether medical device
This is primary question to clarify whether products are medical device. Manufacturer could have one non-medical and another one medical claim to start the commercialization. As said before, an application and even communication with authority are worthy to know the opinion of CA or NB.
Brief intended use
This is most findings by CA or NB that manufacturer has no general intended use. Due to too complex intended use it makes difficult to find evidence and even to fine equivalent device for technical documentation especially at FDA.
Variant of intended use (intended purpose)
It makes sense to make a different intended use in US and China for European manufacturers. It leverage to a simple requirement of dossier to submit.
For FDA indication for use matters too to state seperately again. For China the intended use translated in Chinese must be under scope of classification catalog to avoid deficiency or extra testing or trial.
In many markets there are scopes of classification panels, it is suggested to approach/consider intended use to the classification panels
Match of other requirements
Do NOT just have numbers or digits of classification or product code. Using these to have a lateral search of competitors, guidance, standards and labelling.