Dear all,
We hare happy to announce the renewal of the CE MDRs (Medical Devices Regulation) for most InBody Models.
What is CE Medical Devices Regulation (MDR)?
CE MDR stands for Conformité Européenne Medical Devices Regulation, a regulation established bythe European Union to ensure the safety, quality, and performance of medical devices. The CEmarking signifies that our products comply with the essential requirements outlined in the MDR andcan be legally marketed and sold within the European Economic Area (EEA). The Medical DevicesRegulation (MDR) was introduced to address shortcomings and enhance the previous regulatoryframework, Medical Device Directive (MDD), for medical devices in the European Union.
What's changed compared to the CE Medical Device Directive (MDD)?
Unlike the Medical Device Directive (MDD), which operated in a directing capacity, the Medical Devices Regulation (MDR) represents a binding regulation. It aims to establish a uniform approach throughout all EU member states, prioritizing consistency in standards, offering clearer definitions, and reducing ambiguity compared to the MDD. The overarching goal of MDR is to enhance patient safety, bolster the reliability of medical devices, and create a cohesive market for these products across the EU.
Why is this important?
Securing CE MDR certification highlights our unwavering dedication to excellence and strictadherence to the highest standards in the medical device industry. Beyond being a testament to ourcommitment, this achievement strengthens our position in the market, fostering trust among ourcustomers, partners, and regulatory authorities. Attaining CE MDR certification is a significantaccomplishment given the demanding regulations, setting our brand apart in the industry. It is worthnoting that a considerable number of medical device companies may not have successfully obtainedthis prestigious certification.
Device list :
BIA Devices :
InBody770 - Basic UDI-DI : 880920959C7YC
BWA ON - Basic UDI-DI : 880920959M3Z2
BWA2.0 - Basic UDI-DI : 880920959I3YN
InBodyH20/H20Ⓑ - Basic UDI-DI : 880920959G5YL
CHA1.0 - Basic UDI-DI : 880920959P5ZF
InBody120 - Basic UDI-DI : 880920959F3YD
InBody270/260/470 - Basic UDI-DI : 880920959F9YR
InBody380 - Basic UDI-DI : 880920959P9ZP
InBody580 - Basic UDI-DI : 880920959R6ZP
InBody970 - Basic UDI-DI : 880920959I4YQ
InBody S10 - Basic UDI-DI : 88092095983X6
InBody370S - Basic UDI-DI : 880920959I5FW
Class IIa - MDA0203, MDS1009, MDS1010
Blood Pressure Monitor :
BPBIO320, BPBIO320n - Basic UDI-DI : 880920959F2YB
BP170, BP170B, BP160, BP160B - Basic UDI-DI : 880920959L5Z3
BPBIO220, BPBIO210 - Basic UDI-DI : 880920959K6Z2
BPBIO250 - Basic UDI-DI : 880920959K9Z8
BPBIO320S, BPBIO330, BPBIO330n, BPBIO330S Basic UDI-DI : 880920959F2YB
BPBIO750 - Basic UDI-DI : 880920959H2YH
Please find attached an explanation sheet, as well as a copy of the MDR Certificate.
Explanation_240115_CE Medical Devices Regulation (MDR) (1).pdfINBODY_200385_APR_Certificate_MDR_issue 2 (1).pdf