Continuous glucose monitoring system

Continuous glucose monitor testing

Continuous glucose monitor testing is the widest path in this map, because a sensor that breaks the skin and is supplied sterile adds four laboratory categories that a surface-contact wearable never touches.

A skin-inserted sensor plus a wireless transmitter and a phone or receiver app.

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.

1 answer turned off. The categories they trigger are faded, not removed.

What continuous glucose monitoring system testing may involve

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

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 sensor filament sits under the skin for up to 14 days, this may require biological evaluation testing.

Subcutaneous placement moves this out of the surface-contact category entirely, which is a much larger biological evaluation.

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
ISO 10993-7Not harmonised under the MDR
Ethylene oxide sterilization residuals.
Applies only where the product is sterilized with ethylene oxide, which is how the sterilization answer feeds back into the biocompatibility one.
Why? S033
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.

C06

Sterilization process validation

Qualifying a specific sterilization process for a specific product and load, including residuals where applicable.

If the sensor applicator is supplied sterile, this may require sterilization process validation.

A skin-piercing component supplied sterile needs a validated sterilization process for that specific product and load.

ISO 11137-1Harmonised under the MDR
Cited edition: EN ISO 11137-1:2015 / EN ISO 11137-1:2015/A2:2019 (entry 3)
Development, validation and routine control of a radiation sterilization process: the dominant method for dry, packaged, single-use product.
Why? S035
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617, entry 3 read verbatim 2026-08-17
ISO 11135Harmonised under the MDR
Cited edition: EN ISO 11135:2014 / EN ISO 11135:2014/A1:2019 (entry 2)
Development, validation and routine control of an ethylene oxide sterilization process: the dominant method for assembled polymer devices.
Why? S034
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617, entry 2 read verbatim 2026-08-17
ISO 11137-2Harmonised under the MDR
Cited edition: EN ISO 11137-2:2015 / EN ISO 11137-2:2015/A1:2023 (entry 22)
Establishing the sterilization dose.
Dose setting depends on measured bioburden, which is what chains sterilization validation to routine microbiology.
Why? S036
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617, entry 22 read verbatim 2026-08-17

Coverage in our register is thin: 2 laboratories reference this (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.

C07

Bioburden and sterility testing

Routine bioburden enumeration and the sterility tests that support the sterilization process.

If the product is supplied sterile and needs routine bioburden control, this may require bioburden and sterility testing.

Bioburden monitoring is what keeps a validated sterilization process valid over time.

ISO 11737-1Harmonised under the MDR
Cited edition: EN ISO 11737-1:2018 / EN ISO 11737-1:2018/A1:2021 (entry 8)
Determination of the population of viable microorganisms on product: the routine test that keeps a validated sterilization process valid.
Why? S039
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617, entry 8 read verbatim 2026-08-17
ISO 11737-2Harmonised under the MDR
Cited edition: EN ISO 11737-2:2020 (entry 4)
Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
This is not the pharmacopoeial product-release sterility test. It supports the process, which is a distinction buyers get wrong.
Why? S040
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617, entry 4 read verbatim 2026-08-17

26 accredited laboratories in our register hold ISO 11737-1 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.

C08

Packaging validation and shelf-life testing

Seal strength, package integrity, accelerated and real-time aging, and distribution simulation of the packaged product.

If the sterile barrier system carries a shelf-life claim, this may require packaging validation and shelf-life testing.

The sterile barrier is what carries the sterility claim all the way to the point of use.

ISO 11607-1Harmonised under the MDR
Cited edition: EN ISO 11607-1:2020 / EN ISO 11607-1:2020/A1:2023 (entry 23)
What a sterile barrier system has to achieve for a terminally sterilized device.
Why? S042
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617, entry 23 read verbatim 2026-08-17
ISO 11607-2Harmonised under the MDR
Cited edition: EN ISO 11607-2:2020 / EN ISO 11607-2:2020/A1:2023 (entry 24)
Validation of the forming, sealing and assembly processes. The two parts are normally bought together.
Why? S043
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617, entry 24 read verbatim 2026-08-17
ASTM F1980Not harmonised under the MDR
Accelerated aging: how a five-year shelf-life claim gets supported before five years have passed.
Why? S044
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617: no ASTM standard appears on the list (absence re-verified 2026-08-17)
ASTM F88Not harmonised under the MDR
Seal strength of flexible barrier materials: the routine mechanical test behind ISO 11607-2.
Why? S045
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617: absence re-verified 2026-08-17
ASTM F1929 and ASTM F2096Not harmonised under the MDR
The two common whole-package integrity methods: dye penetration for seal leaks, and internal pressurization for gross leaks.
Why? S046
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617: absence re-verified 2026-08-17
ASTM D4169 and the ISTA seriesNot harmonised under the MDR
Distribution simulation: what proves the sterile barrier survives the journey, not just the shelf.
Why? S047
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617: absence re-verified 2026-08-17 for both ASTM and ISTA

19 laboratories in our register reference ISO 11607-1 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.

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 transmitter contains a Bluetooth radio, this may require radio and radio-frequency exposure testing.

The transmitter is radio equipment in its own right.

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 transmitter contains a rechargeable lithium cell, this commonly involves battery and cell safety testing.

Cell safety for a transmitter worn against the body. Chemistry decides the standard, so the question is asked as a condition rather than assumed.

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 sensors and transmitters containing lithium cells ship to patients, this may require un 38.3 transport testing.

Direct-to-patient shipping of lithium-containing devices is the normal distribution model here.

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.

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

This map does not yet cover measurement-performance testing for glucose sensors

No consensus laboratory standard for the accuracy of a continuous interstitial glucose sensor is validated in our map. ISO 15197 is written for blood glucose meters, and applying it to a continuous sensor would be an extrapolation, so we leave the category out rather than print a requirement we cannot stand behind.

Routing for primary lithium cells is not yet validated in our map

The battery card above fires only for a rechargeable cell. Where a transmitter uses a primary lithium cell, IEC 62133-2 is the wrong standard by its own scope, and we have not yet validated what the right one is.

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.