Important notice about adjusted MDR legislation
15/01/2020
The new European MDR legislation (Medical Device Regulation) enters into full effect as of 26 May 2020. Healthcare organisations have major concerns about the certification (CE mark) of e.g. communication platforms. Unmatched, developer of the LynX® communication platform, assumed its responsibility and researched the issue for you.
MDR is intended to increase patient safety in healthcare organisations by improving the traceability of products. These regulations enter into full effect as of 26 May 2020. Healthcare organisations, primarily hospitals, are rightly wondering whether they and their suppliers are compliant with these regulations. Naturally, the LynX alarm server - which serves as the communication platform for over 400 Belgian healthcare organisations - also comes up as a subject of this study.
LynX® is an alarm server that is designed for healthcare (and other) institutions. The alarm server´s software detects incoming alarm messages originating from a wide range of devices and equipment (personal alarms, classic panic buttons, reanimation systems, electrodes of automatic defibrillators, medical wearables, and so on). The devices and equipment to which LynX® is linked can be both medical and non-medical in kind. After alarm messages are detected, the alarm server immediately determines which care giver the alarm in question should be sent to and passes it on, so the message quickly gets to the right person(s).
Recent research commissioned by the manufacturer Unmatched and conducted by Julie Hantson, a specialist on the subject, arrived at the following conclusions:
The LynX® software itself – as it exists today, in its current version – is not a medical device, which means that this software does not fall within the scope of application of the Medical Device Regulation (MDR), and therefore a CE mark is not required. Taking into account the future expansion of the functionalities of LynX®, Unmatched is prepared to make this upgraded software version compliant with the Medical Device Regulation.
As a result of misleading advertising by a certain competitor/colleague (who will remain nameless here), we find it important to make accurate information available.
15/01/2020
The new European MDR legislation (Medical Device Regulation) enters into full effect as of 26 May 2020. Healthcare organisations have major concerns about the certification (CE mark) of e.g. communication platforms. Unmatched, developer of the LynX® communication platform, assumed its responsibility and researched the issue for you.
MDR is intended to increase patient safety in healthcare organisations by improving the traceability of products. These regulations enter into full effect as of 26 May 2020. Healthcare organisations, primarily hospitals, are rightly wondering whether they and their suppliers are compliant with these regulations. Naturally, the LynX alarm server - which serves as the communication platform for over 400 Belgian healthcare organisations - also comes up as a subject of this study.
LynX® is an alarm server that is designed for healthcare (and other) institutions. The alarm server´s software detects incoming alarm messages originating from a wide range of devices and equipment (personal alarms, classic panic buttons, reanimation systems, electrodes of automatic defibrillators, medical wearables, and so on). The devices and equipment to which LynX® is linked can be both medical and non-medical in kind. After alarm messages are detected, the alarm server immediately determines which care giver the alarm in question should be sent to and passes it on, so the message quickly gets to the right person(s).
Recent research commissioned by the manufacturer Unmatched and conducted by Julie Hantson, a specialist on the subject, arrived at the following conclusions:
The LynX® software itself – as it exists today, in its current version – is not a medical device, which means that this software does not fall within the scope of application of the Medical Device Regulation (MDR), and therefore a CE mark is not required. Taking into account the future expansion of the functionalities of LynX®, Unmatched is prepared to make this upgraded software version compliant with the Medical Device Regulation.
As a result of misleading advertising by a certain competitor/colleague (who will remain nameless here), we find it important to make accurate information available.