Industry information
Latest medical devices and important developments and regulatory updates in the EU
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
The European Parliament has approved a further extension of the MDR transition period
Extend the MDR transition period
On 6 January 2023 (European time), the European Commission published Proposal 2023/0005(COD) on the transition period provisions amending Regulations (EU)2017/745 and (EU)2017/746. On February 16, 2023, the European Parliament voted on the transition proposal put forward by the European Commission, and it was formally adopted by 537 votes. The final amendment will be published in the Official Journal of the EU (OJ)
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 medical device bidding/M&A information 1
Eu medical device bidding/M&A information 1
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.
What is the UDI-DI deadline?
MDR UDI medical Devices
UDI obligations: apply the date of implementation of the two new regulations, namely medical devices May 26, 2021, and in vitro diagnostic devices May 26, 2022.
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.
Eu medical device bidding/M&A information 2
Eu medical device bidding/M&A information 2
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.
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.
Seminars and Events 01
Seminars and Events 01
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Seminars and Events 02
Seminars and Events 02
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