Wearable ECG patch monitor

Wearable ECG patch testing

Wearable ECG patch testing usually spans nine laboratory categories, because one product is at once a medical electrical device, a radio, a battery and something stuck to skin for days.

An adhesive single-patient patch that records the heart's electrical activity (an electrocardiogram, or ECG) for days at a time.

This is a map of what testing a product class commonly needs. It is not regulatory advice, and it does not replace your own risk analysis or a notified body's view.

What the terms on this page mean

MDR:: the EU Medical Device Regulation, the law a medical device must satisfy to be sold in the EU.
RED:: the EU Radio Equipment Directive, the law that applies on top of the MDR as soon as your product contains a radio such as Bluetooth or Wi-Fi.
Harmonised:: a standard named on the EU's official list. Testing to it earns presumption of conformity, meaning the authorities accept it as proof without further argument.
Accredited scope:: the exact list of tests a laboratory has been independently assessed to perform, published by its national accreditation body.

Tell us about your product

These are the answers that change which testing applies. Everything below stays on the page either way; turning an answer off only fades the categories it triggers.

Showing every category that applies to a typical example of this product.

What wearable ecg patch monitor testing may involve

9 laboratory categories. The laboratory counts below were taken from our register on 2026-08-18.

C01

Electromagnetic compatibility testing

Emissions and immunity measurement in a chamber, plus immunity to mains disturbances.

If the device is electrically powered, this may require electromagnetic compatibility testing.

A powered body-worn recorder has to keep recording correctly near phones and other emitters.

IEC 60601-1-2Not harmonised under the MDR
The single named EMC standard for medical electrical equipment worldwide, and the one most often wrongly assumed to be harmonised under the MDR.
Why? S001
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617: no entry references EN 60601-1-2 in any edition (absence re-verified 2026-08-17)
CISPR 11 and EN 55011Not harmonised under the MDR
The emissions limits IEC 60601-1-2 calls up for medical electrical equipment.
Why? S002
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617: absence re-verified 2026-08-17
The IEC 61000-4 seriesNot harmonised under the MDR
The basic immunity test methods IEC 60601-1-2 references for each phenomenon: electrostatic discharge, radiated fields, fast transients, surges and voltage dips.
Why? S003
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617: absence re-verified 2026-08-17 for EN 61000, any part

34 accredited laboratories in our register hold IEC 60601-1-2 in scope (counted 2026-08-18). See the labs

A laboratory can hold capability that its published scope text does not itemize. Absence from these counts is not evidence of absence.

C02

Medical electrical safety testing

Leakage current, dielectric strength, mechanical and thermal hazards and single-fault conditions, plus verification that the device still performs when stressed.

If a powered part of the device touches the patient, this may require medical electrical safety testing.

The electrodes are a type BF applied part, so leakage current and single-fault safety apply.

IEC 60601-1Harmonised under the MDR
Cited edition: EN 60601-1:2006 / EN 60601-1:2006/A13:2024 (entry 65)
The foundation standard for every powered medical device: leakage current, dielectric strength, mechanical and thermal hazards, and single-fault safety.
The list cites this edition. Whether the presumption extends to the A1:2013, A12:2014 and A2:2021 amendments is not stated in the Official Journal text, so this map does not claim it.
Why? S005
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617, entry 65 read verbatim 2026-08-17
IEC 60601-1-11Not harmonised under the MDR
The home healthcare environment collateral standard. It is the switch that opens a wider environmental and usability envelope for any home-use device.
Why? S007
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617: absence re-verified 2026-08-17

37 accredited laboratories in our register hold IEC 60601-1 in scope (counted 2026-08-18). See the labs

A laboratory can hold capability that its published scope text does not itemize. Absence from these counts is not evidence of absence.

C03

Radio and radio-frequency exposure testing

Radiated power, spectrum occupancy, adaptivity, receiver blocking, radio-specific electromagnetic compatibility, and radio-frequency exposure assessment.

If the device contains a Bluetooth radio, this may require radio and radio-frequency exposure testing.

A BLE radio makes the product radio equipment in its own right, on top of being a medical device.

EN 300 328Cited under the RED
Cited edition: EN 300 328 V2.2.2 (Annex I)
The standard behind every Bluetooth and 2.4 GHz Wi-Fi device sold in the EU: radiated power, spectrum occupancy, adaptivity and receiver blocking.
Applying it only partially, or deviating from it, forces EU-type examination by a notified body under RED Article 3(2) and 3(3). That is the real cost driver.
Why? S010
Consolidated RED harmonised-standards list, Implementing Decision (EU) 2022/2191 as amended, CELEX 02022D2191-20251211, Annex I read verbatim 2026-08-17: cited with no restriction notices
EN 301 489-17Cited under the RED with restrictions
Cited edition: EN 301 489-17 V3.3.1 (Annex I)
Radio-specific electromagnetic compatibility, separate from and additional to IEC 60601-1-2.
Two notices attach: the citation gives no coverage below 9 kHz, and there is no presumption of conformity with Article 3(1)(b) where clause 6 is applied. The presumption is therefore partial.
Why? S012
Consolidated RED harmonised-standards list, Implementing Decision (EU) 2022/2191 as amended, CELEX 02022D2191-20251211, both restriction notices read verbatim 2026-08-17
EN 301 489-1Not cited under the RED
The common radio-EMC part. Counter-intuitively it is not itself cited, which laboratories and buyers both tend to assume it is.
Only parts -3, -12, -17, -19, -20, -28, -52 and -54 are cited. Part -1 appears only as a normative reference inside those.
Why? S013
Consolidated RED harmonised-standards list, Implementing Decision (EU) 2022/2191 as amended, CELEX 02022D2191-20251211: verified absent 2026-08-17
EN 50566Cited under the RED
Cited edition: EN 50566:2017/A1:2023 (entry 4a)
The route by which radio-frequency exposure for a body-worn device reaches presumption of conformity.
EN 50566 covers hand-held and body-mounted use, which is the operative one for anything worn on the body. EN 50360:2017/A1:2023 (entry 1a) covers next-to-the-ear use and does not stand in for it.
Why? S014
Consolidated RED harmonised-standards list, Implementing Decision (EU) 2022/2191 as amended, CELEX 02022D2191-20251211, entries 1a and 4a read verbatim 2026-08-17

13 accredited laboratories in our register hold EN 300 328 in scope (counted 2026-08-18). See the labs

A laboratory can hold capability that its published scope text does not itemize. Absence from these counts is not evidence of absence.

C04

Battery and cell safety testing

Cell and pack abuse testing: overcharge, forced discharge, external short circuit, crush, impact, thermal abuse and vibration.

If the device contains a rechargeable lithium cell, this may require battery and cell safety testing.

In-use cell safety for a device worn against the body for days at a time.

IEC 62133-2Not harmonised under the MDR
Cell and pack abuse testing: overcharge, forced discharge, external short circuit, crush, impact, thermal abuse and vibration.
Its scope covers portable sealed SECONDARY lithium cells only, so it is the right standard only where the cell is rechargeable. It is recognized by the FDA (recognition number 19-55, entered 2025-05-26, complete recognition).
Why? S018
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617: absence re-verified 2026-08-17. Scope re-read from the IEC catalogue 2026-08-17

35 laboratories in our register reference IEC 62133-2 in their published scope text (counted 2026-08-18). Search the register

A laboratory can hold capability that its published scope text does not itemize. Absence from these counts is not evidence of absence.

C13

UN 38.3 transport testing

The eight-test transport sequence plus the test summary document.

If the device or a spare lithium cell is shipped, this may require un 38.3 transport testing.

Separate from cell safety: this is a shipping gate. Without it the product cannot legally move by air.

UN 38.3A transport regime, not a device standard
The eight-test transport sequence: altitude, thermal cycling, vibration, shock, external short circuit, impact or crush, overcharge and forced discharge.
Transport qualification, not product safety, and routinely forgotten until a shipment is blocked. It is not a medical device standard, so the FDA recognized-standards database holds no record of it and never will.
Why? S021
UN Manual of Tests and Criteria, Part III sub-section 38.3, tests T1 to T8. It is invoked by the rulebooks for every transport mode: air (the ICAO Technical Instructions and the IATA Dangerous Goods Regulations), sea (the IMDG Code) and road and rail (ADR and RID). Newest published revision Rev.8 (2023) with Amendment 1 (2025)
UN 38.3 as applied in the United StatesA transport regime, not a device standard
The US and the international modal regimes sit on different revisions of the same document, so a US-market buyer and an EU-market buyer get different answers.
As of 2026-08-17 the US still mandates Rev.7 with Amendment 1. The HM-215R proposal to move to Rev.8, dated 2026-02-10, was not final on that date.
Why? S022
49 CFR 173.185, with the incorporated revision fixed by 49 CFR 171.7(dd)
The UN 38.3 test summaryA transport document requirement, not a device standard
The deliverable is a document, not a pass or a fail. Buyers often do not realise the summary is the thing they are actually purchasing.
Grandfathering applies: a type stays valid against the revision in force when it was first tested, so a design first tested now should be tested to Rev.8.
Why? S023
49 CFR 173.185(a)(3), which sets out the ten required elements

22 laboratories in our register reference UN 38.3 in their published scope text (counted 2026-08-18). Search the register

A laboratory can hold capability that its published scope text does not itemize. Absence from these counts is not evidence of absence.

C05

Biological evaluation testing

Cytotoxicity, sensitization and irritation, and where the contact category demands it systemic toxicity, plus chemical characterization and toxicological risk assessment.

If the adhesive contacts intact skin for more than 24 hours, this may require biological evaluation testing.

Prolonged skin contact puts the adhesive and the electrode gel into the prolonged surface-contact category.

ISO 10993-1Harmonised under the MDR
Cited edition: EN ISO 10993-1:2025 (entry 54)
The gateway standard. It decides, from the nature and duration of contact, which other parts apply.
Why? S024
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617, entry 54 read verbatim 2026-08-17
ISO 10993-5Harmonised under the MDR
Cited edition: EN ISO 10993-5:2009 / EN ISO 10993-5:2009/A11:2025 (entry 55)
In vitro cytotoxicity: the universal screening test that essentially every patient-contacting device gets.
Why? S025
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617, entry 55 read verbatim 2026-08-17
ISO 10993-10Harmonised under the MDR
Cited edition: EN ISO 10993-10:2023 (entry 17)
Tests for skin sensitization.
Irritation moved out of part 10 into part 23 at the 2021 revision. A quote that still says '10993-10 irritation and sensitization' is quoting a superseded structure.
Why? S026
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617, entry 17 read verbatim 2026-08-17
ISO 10993-23Harmonised under the MDR
Cited edition: EN ISO 10993-23:2021; EN ISO 10993-23:2021/A1:2025 (entries 1 and 1a)
Tests for irritation: the other half of the old part 10.
Entry 1 loses its citation on 2027-12-15, as the list read on 2026-08-17.
Why? S027
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617, entries 1 and 1a read verbatim 2026-08-17
ISO 10993-12Harmonised under the MDR
Cited edition: EN ISO 10993-12:2021; EN ISO 10993-12:2021/A1:2025 (entries 7 and 7a)
Sample preparation and reference materials. Not a test in itself, but the extraction rules that make every other part comparable.
Why? S028
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617, entries 7 and 7a read verbatim 2026-08-17
ISO 10993-18Harmonised under the MDR
Cited edition: EN ISO 10993-18:2020 / EN ISO 10993-18:2020/A1:2023 (entry 21)
Chemical characterization: the extractables and leachables work that increasingly replaces animal testing.
Why? S029
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617, entry 21 read verbatim 2026-08-17
ISO 10993-17Harmonised under the MDR
Cited edition: EN ISO 10993-17:2023; EN ISO 10993-17:2023/A1:2025 (entries 20 and 20a)
Toxicological risk assessment: it turns the part 18 chemistry result into a risk conclusion.
A risk assessment rather than a bench test, which is why laboratory coverage for it is thin. Entry 20 loses its citation on 2027-12-15, as the list read on 2026-08-17.
Why? S030
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617, entries 20 and 20a read verbatim 2026-08-17
ISO 10993-11Not harmonised under the MDR
Tests for systemic toxicity.
Triggered by the prolonged and permanent contact categories, not by limited surface contact.
Why? S032
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617: absence re-verified 2026-08-17

29 laboratories in our register reference ISO 10993-1 in their published scope text (counted 2026-08-18). Search the register

A laboratory can hold capability that its published scope text does not itemize. Absence from these counts is not evidence of absence.

C09

Usability engineering and human factors evaluation

Formative and summative evaluation with representative users, use-error analysis, and evidence that the interface does not induce harm.

If the patient applies and wears it themselves at home, this may require usability engineering and human factors evaluation.

A lay user applying their own patch is a use-error risk that has to be evaluated.

IEC 62366-1Not harmonised under the MDR
The usability engineering process: formative and summative evaluation with representative users, and evidence that the interface does not induce harm.
The named usability standard for medical devices is not harmonised under the MDR, which surprises most buyers.
Why? S048
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617: absence re-verified 2026-08-17
IEC 60601-1-6Not harmonised under the MDR
The bridge that applies the general usability process to medical electrical equipment.
Why? S049
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617: absence re-verified 2026-08-17

29 laboratories in our register reference IEC 62366-1 in their published scope text (counted 2026-08-18). Search the register

A laboratory can hold capability that its published scope text does not itemize. Absence from these counts is not evidence of absence.

C10

Environmental, mechanical and ingress testing

Temperature, humidity, vibration, shock, drop, and ingress-protection classification.

If it is worn continuously and exposed to sweat, showers and drops, this commonly involves environmental, mechanical and ingress testing.

A body-worn device leaves the controlled clinical environment, so ingress and mechanical robustness become real.

IEC 60529Not harmonised under the MDR
Where an ingress rating claim such as IP22 or IP67 gets verified.
Why? S050
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617: absence re-verified 2026-08-17
The IEC 60068 seriesNot harmonised under the MDR
The basic climatic and mechanical methods: cold, dry heat, damp heat, vibration, shock and free fall.
Why? S051
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617: absence re-verified 2026-08-17 for EN 60068, any part

30 accredited laboratories in our register hold IEC 60529 in scope (counted 2026-08-18). See the labs

A laboratory can hold capability that its published scope text does not itemize. Absence from these counts is not evidence of absence.

C12

Measurement accuracy and performance testing

Bench and, where required, clinical validation of the specific measurement claim against the particular standard for that device class.

If it makes an ECG measurement claim, this may require measurement accuracy and performance testing.

The particular standard for ambulatory ECG defines the accuracy and arrhythmia-detection requirements.

IEC 60601-2-47Not harmonised under the MDR
Ambulatory electrocardiographic systems: the accuracy and arrhythmia-detection requirements for Holter and patch recorders.
Why? S056
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617: absence re-verified 2026-08-17

51 laboratories in our register reference IEC 60601-2-47 in their published scope text (counted 2026-08-18). Search the register

A laboratory can hold capability that its published scope text does not itemize. Absence from these counts is not evidence of absence.

What does not apply, and what we cannot yet tell you

These are statements about the regulation or about our own map. They are not advice, and they carry no status colour because nothing here was verified about your product.

The EN 18031 cybersecurity series is not required under the RED

Radio equipment that is also a medical device under Regulation (EU) 2017/745 or an in vitro diagnostic under 2017/746 is explicitly carved out of RED Article 3(3)(d), (e) and (f). Cybersecurity for these products is governed by MDR Annex I sections 17.2 and 17.4 instead. Guided tools routinely send medical device makers to EN 18031 anyway.

Why? R083

Delegated Regulation (EU) 2022/30 Article 2(1), CELEX 32022R0030, read verbatim 2026-08-17

Next step

Each card above links to the laboratories in our register that hold that standard. If you would rather describe the job in your own words, ask for a recommendation, or go back to the other product types.