Medical device regulations
Medical device regulations
EU UDI server information summary
Unique Device Identifiers European Commission
Regulation (EU) 2017/745 on medical devicesEN••• and Regulation (EU) 2017/746 on in vitro diagnostic medical devicesEN••• introduce an EU device identification system based on a unique device identifier (UDI) allowing easier traceability of medical devices. This requires that manufacturers submit in EUDAMED the UDI/Device information of all devices they place on the EU market. Manufacturers can already enter UDI/Device information in the system on a voluntary basis.
2023.03.15 Council Regulation (EU)2017/745 MDR Amendment 2023/607 and FAQ on extension of CE certificate for MDD
FAQ on the Extension of the Transitional Period MDR Amendment CE Certificate Extension
A written MDR review contract with a notified body must be signed before the specified time (the old certificate is valid by September 26, 2024 at the latest) to apply the extended transition period. 2023/607 and FAQ on CE certificate extension for MDD
Overview of medical device management and regulations in various ries
Food and Drug Administration Medical Device Directive 93/42/EEC
With the rising global medical demand, the overall market size continues to expand. While continuously expanding business boundaries and enriching product structure, domestic and foreign medical device enterprises must strictly abide by relevant laws and regulations to protect the life and health of users.
Eu Rules for the classification of medical devices
Non-invasive devices Active device implantation devices
Medical devices in the European Union are divided into four categories: I, IIa, IIb and III. These four categories overlap and intersect with the categories of non-invasive devices, invasive devices, and active devices.
Introduction to the EU Medical Device MDR regulation
MDR AIMDD Medical Device Directive
The new Medical Device Regulation MDR encompasses medical devices covered by the General Medical Device MDD Directive as well as all products covered by the AIMDD, the purpose of which is to ensure better protection of public health and patient safety.