The main EU legislation on medical device classification is the EU Medical Device Regulation (Regulation (EU) 2017/745, MDR), and the main guidance document is MDCG 2021-24, Guidance on classification of medical devices. The Regulation divides medical devices into Classes I, IIa, IIb and III. Our earlier WeChat articles covered EU Class I and Class IIa products in detail.
This issue introduces EU Class IIb products under the 22 classification rules of the MDR, in one chart:
More articles:
China NMPA Registration: Applying Real-World Data in Clinical Evaluation of Medical Devices
Detailed Guide to the Medical Device Classification Determination Procedure
The Complete Australian Medical Device Registration Process Explained
Clinical Evaluation Routes and Methods in MDR Certification
Guide to Writing MDR Technical Documentation
EU Safety Rules for Medical Device Apps on Online Platforms
EVERBIZ Certification Services (Shanghai) Co., Ltd. (EVERBIZ) is a professional compliance service platform for testing, certification, consulting and training of medical products, dedicated to helping leading medical R&D companies at home and abroad improve their compliance capabilities and competitiveness. The company has offices and branches in Shanghai (China), Hong Kong, Munich (Germany), Salzburg (Austria) and Thailand, covering nearly 25 industries of compliance products (such as medical devices, new energy, household appliances, lighting, tools, laboratory instruments, machinery, in vitro diagnostics, wireless products and reagents).
Shanghai: Room 705, Building 6, Lane 111, Luxiang Road, Baoshan District, Shanghai | Germany: Landsberger Str. 155, 80687 München, Germany
Austria: Innsbrucker Bundesstraße 136/3, 5020 Salzburg, Austria
Hong Kong: Room A1, 11/F Winner Building, 36 Man Yue Street, Hung Hom, Kowloon, Hong Kong
Thailand: No. 850 Soi Lat Krabang 30/5, Lat Krabang Subdistrict, Bangkok 10520
