CE MDR

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.

⚖️ Classification Rationale & Self-Certification Authority

Classification of TeltoHeart and Manufacturer Self-Certification Authority

TeltoHeart is classified as a Class I medical device in accordance with MDR Rule 13, as it constitutes a general, non-specific active medical device that does not meet the criteria for a higher risk classification under Annex VIII of Regulation (EU) 2017/745.

Under the MDR framework, Class I medical devices are subject to a conformity assessment procedure solely under the authority of the manufacturer, in accordance with MDR Annex II and Annex III, without involvement of a Notified Body. Annex IX, which governs conformity assessment based on a quality management system, is not applicable to Class I devices and therefore does not confer any role or responsibility upon a Notified Body in relation to TeltoHeart.

Accordingly, all decisions regarding the conformity, classification, and any changes to TeltoHeart remain exclusively within the legal responsibility of the manufacturer. No Notified Body holds authority over, or has a reporting relationship with, TeltoHeart in its current classification.

Non-Applicability of MDCG 2020-3

For the avoidance of doubt, MDCG 2020-3 (Guidance on Significant Changes under MDR/IVDR) is not applicable to TeltoHeart.

MDCG 2020-3 was issued exclusively to address the requirements of MDR Article 120(3), which governs devices that held a valid certificate under the Medical Device Directive (MDD) or the Active Implantable Medical Devices Directive (AIMDD) and are transitioning to MDR compliance under the applicable transitional provisions.

TeltoHeart was certified directly under MDR 2017/745 and has never held certification under MDD or AIMDD. The transitional provisions of Article 120 do not apply, and by extension, MDCG 2020-3 has no legal relevance to the assessment of changes to this device.

It is further noted that, as of the date of this document, no finalised MDCG guidance equivalent to NB-MED 2.5.2 Rev 2 exists for MDR-native Class I devices. In the absence of such guidance, and consistent with the self-certification framework described above, the manufacturer retains full and sole authority over the assessment and determination of whether any change to TeltoHeart constitutes a significant change requiring regulatory action.

Reclassification from Non-Medical Device to Class I Medical Device

In accordance with MDCG 2023-4 (Guidance on the classification of combined medical device systems comprising medical and non-medical devices), Teltonika conducted a structured assessment of TeltoHeart's regulatory status within the context of its integration with the MyHealth app system.

MDCG 2023-4 outlines the regulatory implications and practical considerations applicable to systems combining medical and non-medical device components. Following this assessment, Teltonika made a deliberate and documented decision to transition TeltoHeart from its prior status as a non-medical device to a Class I medical device, in order to ensure full regulatory alignment across the combined system and to accurately reflect the device's function as a physiological data acquisition accessory.

This transition reflects a change in regulatory positioning and system classification strategy, not a modification to the device's intended purpose, design, or performance specifications. The device continues to perform the same functions under the same validated performance specifications as before reclassification. As no change to intended purpose has occurred, no reportable change arises from this reclassification under the applicable MDR framework.

📎 Attachments

SW CE MDR Declaration of Conformity MyHealth App — Software Class IIa

Class IIa

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

HW Declaration of Conformity TeltoHeart — Hardware Class I

Class I

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