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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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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:<br>
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* Automatic recording of heart rate data 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 <br>
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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.
<td style="vertical-align: middle; padding-right: 20px; width: 96px; background: #ffffff; border-radius: 8px;">[[File:CE_MDR_labeling.png|alt=CE logo.|center|frameless|100x100px]]</td><td style="vertical-align: left;">
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 style="font-size: 28px; font-weight: 700; color: #ffffff; letter-spacing: -0.5px; margin-bottom: 8px;">CE MDR</div>
MyHealth app and TeltoHeart are 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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==Attachments==
<!-- Regulatory Details -->
<div style="background: #ffffff; border: 1px solid #e2e8f0; border-radius: 10px; padding: 28px 32px; margin-bottom: 28px;">
<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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<td style="width: 50%; background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 14px 18px; vertical-align: top;">
<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Product Software Name</div>
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">MyHealth App</div>
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<td style="width: 50%; background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 14px 18px; vertical-align: top;">
<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Single Registration Number (SRN)</div>
<div style="font-size: 15px; font-weight: 700; color: #2d3748; font-family: 'Courier New', monospace;">LT-MF-000007642</div>
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<td style="background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 14px 18px; vertical-align: top;">
<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Product Classification</div>
<div style="display:inline-block; background: #ebf8ff; color: #2b6cb0; font-size: 13px; font-weight: 700; padding: 4px 14px; border-radius: 20px;">Class IIa</div>
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<td style="background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 14px 18px; vertical-align: top;">
<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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<td style="background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 14px 18px; vertical-align: top;">
<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Notified Body Number</div>
<div style="font-size: 15px; font-weight: 700; color: #2d3748; font-family: 'Courier New', monospace;">1304</div>
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<td style="background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 14px 18px; vertical-align: top;">
<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Notified Body Name</div>
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">SIQ Ljubljana</div>
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</div>


{|style="margin: 0 auto;valign="left""
<!-- Description -->
| [[File:TeltoHeart_DoC_CE_MDR_page_01.png|thumb|left|300px|x300px|SW CE MDR Declaration of conformity, MyHealth app page 1]]
<div style="background: #ffffff; border: 1px solid #e2e8f0; border-radius: 10px; padding: 28px 32px; margin-bottom: 28px;">
| [[File:TeltoHeart_DoC_CE_MDR_page_03.png|thumb|left|300px|x300px|SW CE MDR Declaration of conformity, MyHealth app page 2]]
<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #718096; margin-bottom: 14px;">📄 Description</div>
| [[File:TeltoHeart_DoC_CE_MDR_page_02.png|thumb|left|300px|x300px|SW CE MDR Declaration of conformity, MyHealth app page 3]]
<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>
|}


<table style="width: 100%; border-collapse: collapse; margin-bottom: 16px;">
<tr><td style="padding: 0 0 8px 0;">
<table style="width: 100%; background: #f7fafc; border: 1px solid #e2e8f0; border-left: 4px solid #3182ce; border-radius: 8px; border-collapse: collapse;">
<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>
</table>
</td></tr>
<tr><td style="padding: 0 0 8px 0;">
<table style="width: 100%; background: #f7fafc; border: 1px solid #e2e8f0; border-left: 4px solid #3182ce; border-radius: 8px; border-collapse: collapse;">
<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>
</table>
</td></tr>
<tr><td style="padding: 0 0 8px 0;">
<table style="width: 100%; background: #f7fafc; border: 1px solid #e2e8f0; border-left: 4px solid #3182ce; border-radius: 8px; border-collapse: collapse;">
<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>
</table>
</td></tr>
</table>


You can find PDF version of the declaration (Software Class IIa) '''[[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;">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>


{|style="margin: 0 auto;valign="left""
<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>
| [[File:TeltoHeart_DoC_MDR_page_01.png|thumb|left|300px|x300px|HW MDR Declaration of conformity, TeltoHeart page 1]]
| [[File:TeltoHeart_DoC_MDR_page_02.png|thumb|left|300px|x300px|HW MDR Declaration of conformity, TeltoHeart page 2]]
| [[File:TeltoHeart_DoC_MDR_page_03.png|thumb|left|300px|x300px|HW MDR Declaration of conformity, TeltoHeart page 3]]
| [[File:TeltoHeart_DoC_MDR_page_04.png|thumb|left|300px|x300px|HW MDR Declaration of conformity, TeltoHeart page 4]]
|}


You can find PDF version of the declaration (Hardware Class Ia) '''[[Media:TeltoHeart_DoC_EN_v1.0_2024_11-29.pdf|here]]'''. <br>
<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>
</div>
 
<!-- Attachments -->
<div style="margin-bottom: 28px;">
<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #718096; margin-bottom: 14px;">📎 Attachments</div>
 
<!-- SW Class IIa -->
<div style="background: #ffffff; border: 1px solid #e2e8f0; border-radius: 10px; padding: 24px 28px; margin-bottom: 16px;">
<table style="width: 100%; border-collapse: collapse; margin-bottom: 16px;">
<tr>
<td style="vertical-align: middle; padding-right: 16px;">
<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>
</td>
<td style="text-align: right; vertical-align: middle; white-space: nowrap;">
<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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</table>
<table style="width: 100%; border-collapse: separate; border-spacing: 8px;">
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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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<div style="margin-top: 16px;">
<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) →]]'''
</div>
</div>
 
<!-- HW Class I -->
<div style="background: #ffffff; border: 1px solid #e2e8f0; border-radius: 10px; padding: 24px 28px;">
<table style="width: 100%; border-collapse: collapse; margin-bottom: 16px;">
<tr>
<td style="vertical-align: middle; padding-right: 16px;">
<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>
</td>
<td style="text-align: right; vertical-align: middle; white-space: nowrap;">
<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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<table style="width: 100%; border-collapse: separate; border-spacing: 8px;">
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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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<div style="margin-top: 16px;">
<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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