Global Medical Device Classification Frameworks and Regulations

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Medical Device Classification in the United States

The US FDA employs a unique medical device classification methodology. A device’s classification is determined by its substantial equivalence to a legally marketed device in the US, known as a predicate.

Legally marketed devices are assigned a three-letter product code, which they share with other substantially equivalent devices. Each product code is associated with one of three classification tiers:

Class I (low risk)

Class II (moderate risk)

Class III (high risk)

To understand how US classification impacts regulatory requirements or what to do if your device has no predicate, take a look at our in-depth article on US medical device classification.

To learn more about how you can streamline your medical device to the US market, click here.

Medical Device Classification in Mexico

Mexico’s medical device regulator, the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), takes a two-pronged approach to classification.

The system considers both device grouping and risk classification. Devices are grouped into six “families” based on their intended use:

• • Medical equipment: appliances, accessories, and instruments for medical use
  • Prosthetics, orthotics, and functional aids
  • Diagnostic agents
  • Dental supplies
  • Surgical and healing supplies
  • Hygiene devices

Grouping criteria assessments are necessary to determine how many registrations your device will require. Device variations, accessories, etc., that may be registered under a single submission in other markets may require individual registrations in Mexico.

Once your device group is identified, classification is determined by the Ministry of Health’s classification rules. These rules are similar to those in Europe, with some deviations that are unique to Mexico. Devices are classified into three tiers of increasing risk:

Class I

Class II

Class III

COFEPRIS maintains a list of devices that are not classified as medical devices or are considered lower risk than Class I. If your device is on this list, it may not require registration at all, or you may be able to expedite the registration process.

Medical Device Classification in Europe

Europe follows a rules-based classification system. Annex VIII of the EU Medical Devices Regulation (EU MDR) 2017/745 comprises 22 classification rules that correspond to the following classification tiers:

Class I (low risk)

• • Class I – non-measuring, non-sterile, non-reusable surgical instrument
  • Class Is – sterile device
  • Class Im – device with a measuring function

Class Ir – reusable surgical instrument

Class IIa (moderate risk)

Class IIb (moderate-high risk)

Class III (high risk)

Your classification dictates your conformity assessment route and the level of involvement from a Notified Body, if required. Additionally, certain devices in the EU are classified as medical devices without a medical purpose and are required to follow additional conformity routes along with the EU MDR regulations. For a closer look at how classification works in Europe, check out our in-depth article on EU medical device classification. Note that IVDs are subject to a different set of classification tiers and rules as laid out in the EU In Vitro Diagnostic Devices Regulation (IVDR 2017/746).

To learn more about how you can streamline your medical device to the EU market, click here.

Medical Device Classification in the United Kingdom (UK)

Following Brexit, the UK is no longer a member of the European Union and has established its own medical device regulatory authority, the Medicines and Healthcare Products Regulatory Agency (MHRA), as well as its own conformity assessment mark, the UKCA. However, the MHRA’s classification and conformity assessment procedures align closely with the EU MDR.

General devices are classified according to increasing risk as follows:

Class I – low risk

Class IIa – low-medium risk

Class IIb – medium risk

Class III – high risk

Classification information for active implantable devices and IVDs can be found in the UK MDR 2002.

Devices sold in the UK are required to register with the MHRA and bear the UKCA mark, even if they already have CE Marking. However, the MHRA will recognize certain EC Certificates on a rolling transitional basis through 2030.

To learn more about how you can streamline your medical device to the UK market, click here.

Medical Device Classification in Switzerland

Switzerland is not a member of the European Union and has its own medical device and IVD regulator, the Swiss Agency for Therapeutic Products (Swissmedic). Medical device and IVD manufacturers must comply with Swissmedic’s regulations, specifically the Medical Device Ordinance (MedDo) and the In Vitro Diagnostic Devices Ordinance (IVDO), before they can legally distribute their products in Switzerland. MedDo and IVDO align closely with the MDR and IVDR. However, you must undergo a conformity assessment and Notified Body review according to Swissmedic’s requirements for your product classification and/or product type.

Medical device classification in Switzerland is similar to the EU MDR:

Class I – low risk

Class IIa – low-medium risk

Class IIb – medium risk

Class III – high risk

IVDs are classified similarly to the IVDR:

Class A – low risk

Class B – low-medium risk

Class C – medium risk

Class D – high risk

Medical Device Classification in Australia

The Australian classification system closely mirrors the EU MDR classification guidelines, with similar risk classification tiers:

Class I

Class I Measuring

Class I Sterile

Class IIa

Class IIb

Class III

AIMD (Active Implantable Medical Devices)

In many cases, your classification in Europe will be the same in Australia. However, there are exceptions, and it’s important to confirm your device’s classification according to the Therapeutic Goods Administration (TGA) Classification Principles and Rules. If your classification under TGA rules does not align with your reference market, the TGA may impose additional regulatory requirements.

To learn more about how you can streamline your medical device to the Australian market, click here.

Medical Device Classification in India

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices and IVDs in India according to the Medical Device (Amendment) Rules 2020 and the Drugs and Cosmetics Act of 1940.

Medical devices are categorized into five tiers based on risk:

Class A (non-measuring/non-sterile) – low risk

Class A (measuring/sterile) – low risk

Class B – low-moderate risk

Class C – moderate-high risk

Class D – high risk

Similar to the FDA, CDSCO uses a predicate model to classify devices. Manufacturers must leverage a substantially equivalent device already registered in India. If no viable predicate exists, the device is considered “innovative.” Innovative devices must meet additional clinical requirements, unless you can provide proof of authorization in an acceptable reference market (e.g., US, EU, UK, Australia, Canada, or Japan) or the device is Class A non-measuring/non-sterile.

Class A non-measuring/non-sterile devices are exempt from regulatory review and can be electronically registered with the CDSCO to begin importation. Class A measuring/sterile, Class B, Class C, and Class D devices must submit technical documentation and, in some cases, clinical evidence, which will be reviewed by the CDSCO before approval for registration in India.

To learn more about how you can streamline your medical device to the Indian market, click here.

Medical Device Classification in Egypt

Several markets have fully adopted or modeled their classification rules after Europe’s classification scheme.

Egypt does not have its own classification system and instead references the classification hierarchy outlined in the EU MDR:

Class I – low risk

Class IIa – low-medium risk

Class IIb – medium risk

Class III – high risk

The Egyptian Drug Authority (EDA) leverages authorizations from other major markets and generally accepts the device classification of your reference market, even if you are not using an EC Certificate. However, if your device is registered at a higher risk level in another acceptable reference market, the EDA may require you to reference the higher-risk authorization. This could result in a more rigorous regulatory process and longer review time.

To learn more about how to streamline your medical device for the Egyptian market, click here.

Medical Device Classification Consulting

While many markets leverage similar classification concepts, rules, and schemes, each market introduces nuanced differences to the classification process. Medical device classifications can be costly and may cause delays in the regulatory process. A regulatory expert can accurately determine your classification, allowing you to proceed confidently with registration. MedEnvoy’s consultants are available to classify your medical device or IVD in the markets we support and to identify the regulatory pathway that’s best for your product. To contact our team, click here.

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