Brancheninformationen
Die neuesten Entwicklungen und Aktualisierungen der EU-Vorschriften und Medizinprodukte
EU UDI Informationen zusammenfassen
Die europäische kommission
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.
Das europäische parlament verabschiedete offiziell die verlängerung der mdr-übergangszeit
Die übergangszeit zum MDR verlängern
Am 6. Januar 2023 hat die europäische kommission einen vorschlag zur änderung der verordnung 2017/745 und 2017/746 bekannt gegeben. Am 16. Februar 2023 legte das europäische parlament eine abstimmung über den übergangsvorschlag der europäischen kommission ab und verabschiedete ihn mit 537 stimmen formell. Die endgültige änderung wird dann im offiziellen bulletin der europäischen union (o.j.) veröffentlicht
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.
Seminare und Veranstaltungen 01
dedede研讨会和活动01
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Seminare und Veranstaltungen 02
dedede研计会和活动02
dedede研计会和活动02Lorem ipsum dolor sit amet, consectetur adipisicing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam