CE MDR: Difference between revisions

Revision as of 13:01, 25 June 2026

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.

📋 Regulatory Details

Product Software Name MyHealth App	Single Registration Number (SRN) LT-MF-000007642
Product Classification Class IIa	EC Certificate Number MDR-009
Notified Body Number 1304	Notified Body Name SIQ Ljubljana

✅ Conformity with Harmonized Standards

The conformity with the essential requirements has been demonstrated against the following harmonized standards and other technical specifications:

Regulatory Frameworks MDR: 2017/745/EC + COR1 + COR2 (2019) + AMD2020 GDPR: 2016/679/EC	Risk Management and Usability EN ISO 14971: 2019 + A11:2021 EN 62304: 2006 + Cor.:2008 + A1:2015 EN 62366-1: 2015 + AC:2015 + A1:2020 IEC TR 62366-2: 2016
Labeling and Documentation EN ISO 20417: 2021 EN ISO 15223-1: 2021	Quality Management ISO 13485: 2016 + AC:2018 + A11:2021
Safety Standards EN ISO 80601-2-61: 2019 EN 60601-2-25: 2015 EN 60601-1: 2006 + Cor.:2010 + A1:2013 + AC:2014 + A1:2013/AC:2014 + A12:2014 + A2:2021/AC2023 EN 60601-1-2: 2015 + A1:2021 EN 60601-1-11: 2015 + A1:2021 EN 60601-1-6: 2010 + A1:2015 + A2:2021
Biological and Environmental Compatibility EN ISO 10993-1: 2020	Electromagnetic and Wireless Standards EN 62311: 2020 EVS EN 303 446-1: V1.2.1:2019 EN 300 328: V2.2.2:2019 47 CFR Part 15, Subpart B 47 CFR Part 15.247
Product Safety and Durability EN 62368-1: 2014 + A11:2017 EN 60529: 2001 + A2:2014 + AC:2019 UL94-HB	Environmental Regulations RoHS: 2011/65/EU + 2015/863/EU REACH: 2006/1907 RED: 2014/53/EU Regulation (EU) 2023/1542

📄 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:

Automatic recording of heart rate data extrapolated from PPG signal

Detection of suspected atrial fibrillation from PPG-based AF algorithm

Manual 6-lead ECG recording using physical electrodes

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

SW CE MDR Declaration of Conformity

MyHealth App — Software Class IIa

Class IIa

Page 1

Page 2

Page 3

Download PDF version of the declaration: CE MDR Declaration of Conformity (Software Class IIa) →

HW MDR Declaration of Conformity

TeltoHeart — Hardware Class I

Class I

Page 1

Page 2

Page 3

Page 4

Download PDF version of the declaration: MDR Declaration of Conformity (Hardware Class I) →

@@ Line 1: / Line 1: @@
 [[Category:TeltoHeart]]
 <div style="font-family: -apple-system, BlinkMacSystemFont, 'Segoe UI', Roboto, sans-serif; max-width: 960px; margin: 0 auto; padding: 16px;">
 <!-- Header -->
 <div style="background: linear-gradient(135deg, #1a1a1a 0%, #2d2d2d 50%, #3a3a3a 100%); border-radius: 12px; padding: 36px 40px; margin-bottom: 28px; box-shadow: 0 4px 24px rgba(0,0,0,0.18);">
@@ Line 47: / Line 45: @@
 <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>
+</td>
+</tr>
+</table>
+</div>
+<!-- Conformity with Harmonized Standards -->
+<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;">✅ Conformity with Harmonized Standards</div>
+<div style="font-size: 14px; color: #2d3748; line-height: 1.7; margin-bottom: 18px;">The conformity with the essential requirements has been demonstrated against the following harmonized standards and other technical specifications:</div>
+<table style="width: 100%; border-collapse: separate; border-spacing: 10px;">
+<tr>
+<td style="width: 50%; background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 14px 18px; vertical-align: top;">
+<div style="font-size: 12px; font-weight: 700; text-transform: uppercase; letter-spacing: 0.5px; color: #2b6cb0; margin-bottom: 8px;">Regulatory Frameworks</div>
+<ul style="margin: 0; padding-left: 18px; font-size: 13px; color: #2d3748; line-height: 1.7;">
+<li>MDR: 2017/745/EC + COR1 + COR2 (2019) + AMD2020</li>
+<li>GDPR: 2016/679/EC</li>
+</ul>
+</td>
+<td style="width: 50%; background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 14px 18px; vertical-align: top;">
+<div style="font-size: 12px; font-weight: 700; text-transform: uppercase; letter-spacing: 0.5px; color: #2b6cb0; margin-bottom: 8px;">Risk Management and Usability</div>
+<ul style="margin: 0; padding-left: 18px; font-size: 13px; color: #2d3748; line-height: 1.7;">
+<li>EN ISO 14971: 2019 + A11:2021</li>
+<li>EN 62304: 2006 + Cor.:2008 + A1:2015</li>
+<li>EN 62366-1: 2015 + AC:2015 + A1:2020</li>
+<li>IEC TR 62366-2: 2016</li>
+</ul>
+</td>
+</tr>
+<tr>
+<td style="background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 14px 18px; vertical-align: top;">
+<div style="font-size: 12px; font-weight: 700; text-transform: uppercase; letter-spacing: 0.5px; color: #2b6cb0; margin-bottom: 8px;">Labeling and Documentation</div>
+<ul style="margin: 0; padding-left: 18px; font-size: 13px; color: #2d3748; line-height: 1.7;">
+<li>EN ISO 20417: 2021</li>
+<li>EN ISO 15223-1: 2021</li>
+</ul>
+</td>
+<td style="background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 14px 18px; vertical-align: top;">
+<div style="font-size: 12px; font-weight: 700; text-transform: uppercase; letter-spacing: 0.5px; color: #2b6cb0; margin-bottom: 8px;">Quality Management</div>
+<ul style="margin: 0; padding-left: 18px; font-size: 13px; color: #2d3748; line-height: 1.7;">
+<li>ISO 13485: 2016 + AC:2018 + A11:2021</li>
+</ul>
+</td>
+</tr>
+<tr>
+<td colspan="2" style="background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 14px 18px; vertical-align: top;">
+<div style="font-size: 12px; font-weight: 700; text-transform: uppercase; letter-spacing: 0.5px; color: #2b6cb0; margin-bottom: 8px;">Safety Standards</div>
+<ul style="margin: 0; padding-left: 18px; font-size: 13px; color: #2d3748; line-height: 1.7;">
+<li>EN ISO 80601-2-61: 2019</li>
+<li>EN 60601-2-25: 2015</li>
+<li>EN 60601-1: 2006 + Cor.:2010 + A1:2013 + AC:2014 + A1:2013/AC:2014 + A12:2014 + A2:2021/AC2023</li>
+<li>EN 60601-1-2: 2015 + A1:2021</li>
+<li>EN 60601-1-11: 2015 + A1:2021</li>
+<li>EN 60601-1-6: 2010 + A1:2015 + A2:2021</li>
+</ul>
+</td>
+</tr>
+<tr>
+<td style="background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 14px 18px; vertical-align: top;">
+<div style="font-size: 12px; font-weight: 700; text-transform: uppercase; letter-spacing: 0.5px; color: #2b6cb0; margin-bottom: 8px;">Biological and Environmental Compatibility</div>
+<ul style="margin: 0; padding-left: 18px; font-size: 13px; color: #2d3748; line-height: 1.7;">
+<li>EN ISO 10993-1: 2020</li>
+</ul>
+</td>
+<td style="background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 14px 18px; vertical-align: top;">
+<div style="font-size: 12px; font-weight: 700; text-transform: uppercase; letter-spacing: 0.5px; color: #2b6cb0; margin-bottom: 8px;">Electromagnetic and Wireless Standards</div>
+<ul style="margin: 0; padding-left: 18px; font-size: 13px; color: #2d3748; line-height: 1.7;">
+<li>EN 62311: 2020</li>
+<li>EVS EN 303 446-1: V1.2.1:2019</li>
+<li>EN 300 328: V2.2.2:2019</li>
+<li>47 CFR Part 15, Subpart B</li>
+<li>47 CFR Part 15.247</li>
+</ul>
+</td>
+</tr>
+<tr>
+<td style="background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 14px 18px; vertical-align: top;">
+<div style="font-size: 12px; font-weight: 700; text-transform: uppercase; letter-spacing: 0.5px; color: #2b6cb0; margin-bottom: 8px;">Product Safety and Durability</div>
+<ul style="margin: 0; padding-left: 18px; font-size: 13px; color: #2d3748; line-height: 1.7;">
+<li>EN 62368-1: 2014 + A11:2017</li>
+<li>EN 60529: 2001 + A2:2014 + AC:2019</li>
+<li>UL94-HB</li>
+</ul>
+</td>
+<td style="background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 14px 18px; vertical-align: top;">
+<div style="font-size: 12px; font-weight: 700; text-transform: uppercase; letter-spacing: 0.5px; color: #2b6cb0; margin-bottom: 8px;">Environmental Regulations</div>
+<ul style="margin: 0; padding-left: 18px; font-size: 13px; color: #2d3748; line-height: 1.7;">
+<li>RoHS: 2011/65/EU + 2015/863/EU</li>
+<li>REACH: 2006/1907</li>
+<li>RED: 2014/53/EU</li>
+<li>Regulation (EU) 2023/1542</li>
+</ul>
 </td>
 </tr>
@@ Line 56: / Line 146: @@
 <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>
 <table style="width: 100%; border-collapse: collapse; margin-bottom: 16px;">
 <tr><td style="padding: 0 0 8px 0;">
@@ Line 74: / Line 163: @@
 </td></tr>
 </table>
 <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>
 <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>
 </div>
@@ Line 85: / Line 171: @@
 <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;">
@@ Line 110: / Line 195: @@
 </div>
 </div>
 <!-- HW Class I -->
 <div style="background: #ffffff; border: 1px solid #e2e8f0; border-radius: 10px; padding: 24px 28px;">
@@ Line 136: / Line 220: @@
 </div>
 </div>
 </div>
 </div>