CE MDR: Difference between revisions
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<td style="vertical-align: middle; padding-right: 28px; width: | <td style="vertical-align: middle; padding-right: 28px; width: 96px; background: #ffffff; border-radius: 8px;">[[File:CE_MDR_labeling.png|alt=CE logo.|center|frameless|100x100px]]</td><td style="vertical-align: left;"> | ||
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<div style="font-size: 28px; font-weight: 700; color: #ffffff; letter-spacing: -0.5px; margin-bottom: 8px;">CE MDR</div> | <div style="font-size: 28px; font-weight: 700; color: #ffffff; letter-spacing: -0.5px; margin-bottom: 8px;">CE MDR</div> | ||
<div style="color: #c4c4c4; font-size: 15px; line-height: 1.6;">The CE logo indicates compliance with the Medical Devices Regulation (MDR), which ensures a unified regulatory framework for medical devices within the European Union.</div> | <div style="color: #c4c4c4; font-size: 15px; line-height: 1.6;">The CE logo indicates compliance with the Medical Devices Regulation (MDR), which ensures a unified regulatory framework for medical devices within the European Union.</div> | ||
Revision as of 13:06, 10 June 2026
Main Page > TeltoHeart > CE MDR
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CE MDR
The CE logo indicates compliance with the Medical Devices Regulation (MDR), which ensures a unified regulatory framework for medical devices within the European Union.
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Description
This medical device, MyHealth app together with accessory medical device TeltoHeart, is intended to be used for patient heart monitoring in hospital and home environments. Heart monitoring functionality consists of:
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Heart rate and rhythm data is interpreted by an algorithm in the MyHealth app, which detects atrial fibrillation and alerts the patient if any are detected by way of notifications on the accessory device TeltoHeart. Electrocardiogram (ECG) is recorded manually on the TeltoHeart device by the patient and can be sent to their medical practitioner (e.g., cardiologist or other qualified medical staff) for further interpretation and help in diagnosis.
The device does not diagnose any medical conditions. For more precise diagnosis, it is recommended to use standalone electrocardiographs or use smart wearable data only in conjunction with additional medical examination data. The diagnosis is determined only by a medical practitioner.
MyHealth app and TeltoHeart are intended for use by adults aged 22 and above.
Attachments
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SW CE MDR Declaration of Conformity
MyHealth App — Software Class IIa
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Class IIa |
 Page 1 |
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Download PDF version of the declaration: CE MDR Declaration of Conformity (Software Class IIa) →
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HW MDR Declaration of Conformity
TeltoHeart — Hardware Class I
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Class I |
 Page 1 |
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Download PDF version of the declaration: MDR Declaration of Conformity (Hardware Class I) →