CE MDR: Difference between revisions
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<td style="vertical-align: middle; padding-right: | <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;"> | ||
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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> | ||
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<!-- Regulatory Details --> | |||
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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> | |||
<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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<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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<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> | |||
<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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<!-- Description --> | <!-- Description --> | ||
<div style="background: #ffffff; border: 1px solid #e2e8f0; border-radius: 10px; padding: 28px 32px; margin-bottom: 28px;"> | <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: 14px;">Description</div> | <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> | <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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<!-- Attachments --> | <!-- Attachments --> | ||
<div style="margin-bottom: 28px;"> | <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> | <div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #718096; margin-bottom: 14px;">📎 Attachments</div> | ||
<!-- SW Class IIa --> | <!-- SW Class IIa --> | ||
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<span style="font-size: 14px; color: #2d3748;">Download PDF version of the declaration: </span>'''[[Media: | <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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<span style="font-size: 14px; color: #2d3748;">Download PDF version of the declaration: </span>'''[[Media:2026-01-26, | <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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