Typically, in the UK, IVD Devices are classified in one of four categories. Class B is the default class that takes in all IVD devices that are not covered specifically in other classification rules.

IVD are classified as Class A Non-sterile & Sterile, B, C, or D as per IVDR 2017/746 Risk-Based Classification Approach. Image Credit: Himedia Laboratories Private Limited ...

2.2 The United States 2.2.1 IVD Classification 2.2.2 Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) 2.2.3 Premarket Notification 510 (k) 2.2.4 De Novo Classification for IVD Devices ...

The global Medical Device Contract Manufacturing Market, valued at US$78.58 billion in 2024, stood at US$83.77 billion in ...

Middle East Medical Device Market to 2025 by Product (IVD, Cardiology, Orthopedics), by FDA classification (Class I, II, III) & End-user - Research and Markets ...

Ecobono received an IVD Class I label, enabling the reagents to be used for IVD in China. “Ecobono is a company that focuses on reproductive clinical and nucleic acid testing.

Australia’s Therapeutic Goods Administration floated a draft rule on risk classification for in vitro diagnostics, which does not apply to home use tests, the subject of impending rulemaking.