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[[file:CE MDR labeling.png|border|class=tlt-border|right|upright=0.3|130px|CE logo.]]
[[Category:TeltoHeart]]
The CE logo indicates compliance with the Medical Devices Regulation (MDR), which ensures a unified regulatory framework for medical devices within the European Union.


==Description==
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'''Software as a Medical Device:''' The MyHealth app, in conjunction with the TeltoHeart smart wearable, is intended for use in patients suspected of having arrhythmias. An advanced PPG-based atrial fibrillation detection and Heart rate monitor algorithms alerts the patient and advises them to perform a 6-lead electrocardiogram either at home or in a hospital environment. Heart monitoring functionality consists of:  
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* Automatic recording of heart rate extrapolated from PPG signal;
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* Detection of suspected atrial fibrillation from PPG-based AF algorithm;
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* Manual 6-lead ECG recording using physical electrodes.  
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Heart rate and rhythm data is interpreted by an algorithm which detects atrial fibrillation and alerts patient if any are detected by way of notifications on the device. <br>
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Electrocardiogram (ECG) is recorded manually 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. <br>
<div style="font-size: 28px; font-weight: 700; color: #ffffff; letter-spacing: -0.5px; margin-bottom: 8px;">CE MDR</div>
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 medical practitioner. MyHealth app is intended for use by adults aged 22 and above.
<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>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #718096; margin-bottom: 16px;">📋 Regulatory Details</div>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Product Software Name</div>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Single Registration Number (SRN)</div>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Product Classification</div>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">EC Certificate Number</div>
<div style="font-size: 15px; font-weight: 700; color: #2d3748; font-family: 'Courier New', monospace;">MDR-009</div>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Notified Body Number</div>
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<div style="font-size: 15px; font-weight: 700; color: #2d3748;">SIQ Ljubljana</div>
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==Attachments==
<!-- Description -->
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #718096; margin-bottom: 14px;">📄 Description</div>
<div style="font-size: 14px; color: #2d3748; line-height: 1.7; margin-bottom: 16px;">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:</div>


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| [[File:TeltoHeart_DoC_CE_MDR_page_01.png|thumb|left|300px|x300px|CE MDR Declaration of conformity, TeltoHeart page 1]]
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| [[File:TeltoHeart_DoC_CE_MDR_page_03.png|thumb|left|300px|x300px|CE MDR Declaration of conformity, TeltoHeart page 2]]
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| [[File:TeltoHeart_DoC_CE_MDR_page_02.png|thumb|left|300px|x300px|CE MDR Declaration of conformity, TeltoHeart page 3]]
<tr><td style="padding: 12px 16px; font-size: 14px; color: #2d3748; line-height: 1.6;">Automatic recording of heart rate data extrapolated from PPG signal</td></tr>
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<tr><td style="padding: 12px 16px; font-size: 14px; color: #2d3748; line-height: 1.6;">Detection of suspected atrial fibrillation from PPG-based AF algorithm</td></tr>
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<tr><td style="padding: 12px 16px; font-size: 14px; color: #2d3748; line-height: 1.6;">Manual 6-lead ECG recording using physical electrodes</td></tr>
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<div style="font-size: 14px; color: #2d3748; line-height: 1.7; margin-bottom: 12px;">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.</div>


You can find PDF version of the declaration '''[[Media:CE_MDR_Declaration_of_conformity,_2024-03-20.pdf|here]]'''. <br>
<div style="font-size: 14px; color: #2d3748; line-height: 1.7; margin-bottom: 12px;">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.</div>
 
<div style="background: #ebf8ff; border: 1px solid #bee3f8; border-left: 4px solid #3182ce; border-radius: 8px; padding: 12px 16px; font-size: 14px; color: #2c5282; line-height: 1.6;">MyHealth app and TeltoHeart are intended for use by adults aged 22 and above.</div>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #718096; margin-bottom: 14px;">📎 Attachments</div>
 
<!-- SW Class IIa -->
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<div style="font-size: 15px; font-weight: 700; color: #1a1a2e; margin-bottom: 4px;">SW CE MDR Declaration of Conformity</div>
<div style="font-size: 12px; color: #718096;">MyHealth App &mdash; Software Class IIa</div>
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<span style="background: #ebf8ff; color: #2b6cb0; font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 0.5px; padding: 4px 10px; border-radius: 20px;">Class IIa</span>
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<td style="width: 33%; text-align: center; background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 8px;">[[File:TeltoHeart_DoC_CE_MDR_page_01.png|250px|SW CE MDR Declaration of conformity, MyHealth app page 1]]<div style="font-size: 11px; color: #718096; margin-top: 6px;">Page 1</div></td>
<td style="width: 33%; text-align: center; background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 8px;">[[File:TeltoHeart_DoC_CE_MDR_page_03.png|250px|SW CE MDR Declaration of conformity, MyHealth app page 2]]<div style="font-size: 11px; color: #718096; margin-top: 6px;">Page 2</div></td>
<td style="width: 33%; text-align: center; background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 8px;">[[File:TeltoHeart_DoC_CE_MDR_page_02.png|250px|SW CE MDR Declaration of conformity, MyHealth app page 3]]<div style="font-size: 11px; color: #718096; margin-top: 6px;">Page 3</div></td>
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<span style="font-size: 14px; color: #2d3748;">Download PDF version of the declaration: </span>'''[[Media:CE MDR Declaration of conformity, 2024-03-20.pdf|CE MDR Declaration of Conformity (Software Class IIa) →]]'''
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<div style="font-size: 15px; font-weight: 700; color: #1a1a2e; margin-bottom: 4px;">HW MDR Declaration of Conformity</div>
<div style="font-size: 12px; color: #718096;">TeltoHeart &mdash; Hardware Class I</div>
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<span style="background: #f0fff4; color: #276749; font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 0.5px; padding: 4px 10px; border-radius: 20px;">Class I</span>
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<td style="width: 25%; text-align: center; background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 8px;">[[File:TeltoHeart_DoC_Class_I_MDR_page_01.png|180px|HW MDR Declaration of conformity, TeltoHeart page 1]]<div style="font-size: 11px; color: #718096; margin-top: 6px;">Page 1</div></td>
<td style="width: 25%; text-align: center; background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 8px;">[[File:TeltoHeart_DoC_Class_I_MDR_page_02.png|180px|HW MDR Declaration of conformity, TeltoHeart page 2]]<div style="font-size: 11px; color: #718096; margin-top: 6px;">Page 2</div></td>
<td style="width: 25%; text-align: center; background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 8px;">[[File:TeltoHeart_DoC_Class_I_MDR_page_03.png|180px|HW MDR Declaration of conformity, TeltoHeart page 3]]<div style="font-size: 11px; color: #718096; margin-top: 6px;">Page 3</div></td>
<td style="width: 25%; text-align: center; background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 8px;">[[File:TeltoHeart_DoC_Class_I_MDR_page_04.png|180px|HW MDR Declaration of conformity, TeltoHeart page 4]]<div style="font-size: 11px; color: #718096; margin-top: 6px;">Page 4</div></td>
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<span style="font-size: 14px; color: #2d3748;">Download PDF version of the declaration: </span>'''[[Media:2026-01-26, Declaration of conformity, TeltoHeart.pdf|MDR Declaration of Conformity (Hardware Class I) →]]'''
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Latest revision as of 13:43, 23 June 2026

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