Medical Device Classification and Characterization

Medical device classification and characterization is a crucial step in determining the Regulatory pathway for a device, based on its risk level. Freyr offers expert analyses for classifying devices in alignment with regional regulations, aiding in the determination of the appropriate Regulatory pathways for successful registration.

Medical Device Classification and Characterization Overview

Medical device classification is a way to categorize medical devices based on their risk level and the Regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. Medical device classification is the primary step in determining the Regulatory pathway for a given product.

The classification rules for diferent Class of medical devices includes

Class I Devices: These are considered low risk devices, and they pose almost no risk to patient safety. CLass I devices are majorly self-certified and do not require the Notified Body (NB) audit to be sold in the market.
Class II Devices: These devices are further classified into Class IIa and Class IIb. Class IIa devices are medium-risk devices and Class IIb are considered to be medium to high-risk devices. They require the NB’s audit for CE mark on the device considered to have a higher risk than Class I devices and require stringent Regulatory control to provide reasonable assurance of the device's safety and effectiveness. Class II devices are subject to General Controls and Special Controls, which may include performance standards, Post-market Surveillance (PMS), patient registries, and special labeling requirements, as per Annexes II and III, as well as Annex VII and Annex IX.
Class III Devices: These are the high-risk devices that aid in supporting the life of a patient. The Class III devices require strong documentation and are mandatorily subject to the NB’s audits for CE mark approval and to the highest level of Regulatory control. Class III devices typically support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury. Class III devices are subject to General Controls and Premarket Approval (PMA), which is a scientific review to ensure the device's safety and efficacy as per Annex X.

IVD Class medical device are based on four risk classes based on both Patient and Public health

Class A devices are non-sterile devices are self-certified. Class A sterile devices must have a QMS as per Annex IX or XI, technical documentation as per Annex II and III, and a Declaration of Conformity (DoC).
Class B devices must have a QMS as per Annex IX (Chapters I and III), technical documentation as per Annex IX, Chapter II (Assessed per device category), and a Declaration of Conformity (DoC).
Class C devices must have a QMS as per Annex IX (Chapters I and III), and technical documentation as per Annex IX, Chapter II (Assessed per generic device), and a Declaration of Conformity (DoC).
Class D devices must have a QMS as per Annex IX (Chapters I and III), and technical documentation excluding Section 5 as per Annex IX and Chapter II. Class D devices have to be verified by the EU reference laboratory and a Declaration of Conformity (DoC).

The Regulatory requirements for medical devices vary depending on the medical device's classification. The requirements can include compliance with specific regulations, such as Quality System Regulations (QSR) (21 CFR Part 820), labeling (21 CFR Part 801), medical device reporting (21 CFR Part 803), and others. Manufacturers must follow the associated controls established by the classification regulation for their devices.

Additionally, the Regulatory requirements may differ based on the jurisdiction, such as the European Union, the United States, Canada, Australia, and Japan. Each has its own set of rules and regulations for medical device classification and conformity assessment procedures.

Freyr helps in performing a detailed analysis of the medical device and identifies the risk class of the device as per the guidelines set by the local health authorities/the Notified Body (NB). Additionally, Freyr provides a justification conclusion of the risk class of the device based on the local regulation and chooses an appropriate Regulatory pathway for successful device registration in the country.