EU Authorized Representative for Continuous Glucose Monitor Manufacturers

Why a CGM is regulated under the MDR, not the IVDR

An in vitro diagnostic device examines specimens outside the body. A CGM sensor measures glucose in interstitial fluid while it remains in the patient, so it is assessed as a medical device under the MDR. The IVDR is still relevant to the product family: a blood glucose meter and strips used to calibrate or confirm readings are IVDs, and MDCG 2020-16 rev.5 gives meters and strips for self-testing of capillary blood glucose as class C examples. A CGM range sold with a meter therefore involves two regulations, two classification exercises and two sets of certificates.

The sensor filament: surgically invasive, short-term or long-term

The filament enters through the skin, not through a body orifice. Annex VIII defines a surgically invasive device as including:

"a device which produces penetration other than through a body orifice" (MDR Annex VIII, Section 2.2(b))

Duration then decides the rule. Short-term use is defined as:

"‘Short term’ means normally intended for continuous use for between 60 minutes and 30 days." (MDR Annex VIII, Section 1.2)

For a single sensor worn for up to 30 days, Rule 7 applies:

"All surgically invasive devices intended for short-term use are classified as class IIa unless they:" (MDR Annex VIII, Rule 7)

None of the Rule 7 exceptions (contact with the heart or central circulatory system, ionising radiation, biological effect or absorption, chemical change in the body, administration of medicines) ordinarily describes a subcutaneous glucose filament. On the rule text alone, the sensor is class IIa at least.

The wear period of one sensor does not end the analysis. Section 3.6 defines continuous use as including:

"the accumulated use of a device that is intended by the manufacturer to be replaced immediately with another of the same type" (MDR Annex VIII, Section 3.6(b))

MDCG 2021-24 treats immediate replacement by the same or an identical device, such as a ureteric catheter, as an extension of continuous use. Where the instructions for use direct the patient to apply a new sensor as soon as the previous one is removed, the accumulated use can exceed 30 days, and the sensor then falls to be assessed as a long-term surgically invasive device. A sensor intended to be implanted and to remain in place for more than 30 days is long-term in any case. Rule 8 then applies:

"All implantable devices and long-term surgically invasive devices are classified as class IIb unless they:" (MDR Annex VIII, Rule 8)

The duration assessment is therefore the first point a notified body will test: a sensor sold for single short-term wear points to Rule 7 and class IIa, while an intended purpose of uninterrupted monitoring with immediate sensor replacement points to Rule 8 and class IIb. One Rule 8 indent raises to class III devices that "are active implantable devices or their accessories". Whether a fully implanted glucose sensor is an active implantable device depends on its design and energy source, and has to be justified in the classification rationale.

The active monitoring function and Rule 10

A sensor–transmitter system works from a source of energy other than the human body, so it is an active device within Article 2(4). Annex VIII defines an active device for diagnosis and monitoring as one used "to supply information for detecting, diagnosing, monitoring or treating physiological conditions" (Section 2.5). Rule 10 then provides:

"if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters and the nature of variations of those parameters is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of the central nervous system, or they are intended for diagnosis in clinical situations where the patient is in immediate danger, in which cases they are classified as class IIb." (MDR Annex VIII, Rule 10)

The rule text does not name glucose. MDCG 2021-24 lists respiration, heart rate, cerebral functions, blood gases, blood pressure and body temperature as examples of vital physiological parameters, and distinguishes continuous surveillance in anaesthesia, intensive care or emergency care (class IIb) from readings obtained as part of routine checkups or self-monitoring (class IIa). The list is not exhaustive, and neither the Regulation nor that guidance classifies CGMs expressly. Where the intended purpose includes alerts for hypoglycaemia or use in hospital settings, the manufacturer must justify why the class IIb indent does or does not apply. Implementing rule 3.5 requires the strictest applicable rule to prevail:

"If several rules, or if, within the same rule, several sub-rules, apply to the same device based on the device's intended purpose, the strictest rule and sub-rule resulting in the higher classification shall apply." (MDR Annex VIII, Section 3.5)

The app, the reader and dosing software

Section 3.3 states that software "which drives a device or influences the use of a device, shall fall within the same class as the device", while independent software is classified in its own right. A standalone app that receives and displays sensor readings and alarms falls under the second paragraph of Rule 11:

"Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb." (MDR Annex VIII, Rule 11)

An app that recommends insulin doses provides information used to take therapeutic decisions and falls under the first paragraph of Rule 11: class IIa, IIb or III according to the impact of an erroneous decision. Where the CGM is integrated into an automated insulin delivery system, Rule 22 places the system in class III, and MDCG 2021-24 lists an automated closed loop insulin delivery system as a Rule 22 example.

Conformity route and legacy certificates

Because no CGM configuration falls below class IIa, a notified body is always involved. For class IIa, Article 52(6) requires Annex IX Chapters I and III with technical documentation assessment of at least one representative device for each category of devices, or Annex II and III documentation with Annex XI. For class IIb, Article 52(4) requires Annex IX with assessment of at least one representative device per generic device group, and for every device where it is implantable. Class III follows Article 52(3). Devices certified under Directive 93/42/EEC may continue under Article 120(3a) as amended by Regulation (EU) 2023/607, until 31 December 2027 for class III and implantable class IIb devices and 31 December 2028 for other class IIb and class IIa devices, provided the conditions of Article 120(3c) are met.

What Medex does under the mandate

Article 11(1) applies to every CGM manufacturer outside the Union:

"Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative." (MDR Article 11(1))

Medex Kurumsal Danışmanlık is registered in EUDAMED as authorised representative under SRN TR-AR-000057550. Our person responsible for regulatory compliance is in-house. Under the mandate we:

review the classification rationale for sensor, transmitter, applicator and app against each Annex VIII rule relied on;

verify the EU declaration of conformity, the technical documentation and the notified body certificates covering every component;

comply with Article 31 registration and verify your Article 27 and 29 registrations in EUDAMED;

keep documentation available to competent authorities and respond to their requests;

forward complaints and incident reports, and cooperate on field safety corrective actions.

Under the EU–Türkiye Customs Union, the Commission Notice of March 2022 states that manufacturers outside the EU and Türkiye "only need to designate one authorised representative, either in the EU or in Turkey", so one Medex mandate covers both markets. We work from Ankara, İstanbul and Gdańsk. Annual fees range from €800 for class I to €2,000 for class III, with no setup fee and €150 for a change of representative. Medex does not write technical documentation or clinical evaluations, is not a notified body, does not find distributors, and cannot act as CH-REP or UK Responsible Person.

Related device categories and country pages

We keep separate pages for other device groups, including IVD reagents and test kits, orthoses, braces and supports and wheelchairs and mobility aids. All groups are listed on the medical device categories page. Most of the manufacturers we represent are based in China, Türkiye, India and South Korea; the full list is on the EU authorized representative by country page. We also cover medical device software.

To check how Annex VIII applies to your own device, use our free MDR classification checker. It walks through rules 1 to 22 and quotes the rule text behind every result.

If your device is still placed on the market under an MDD, AIMDD or IVDD certificate or declaration, the free MDR and IVDR transition deadline checker shows the Article 120 or Article 110 date that applies and the conditions it depends on.

Frequently asked questions

What class is a continuous glucose monitor under the MDR?

A single sensor worn for up to 30 days is class IIa at least under Rule 7. If sensors are intended to be replaced immediately and accumulated use exceeds 30 days, Section 3.6(b) and Rule 8 point to class IIb, as they do for implanted sensors. Rules 10 and 11 can also raise the class.

Is a CGM an in vitro diagnostic device?

No. It measures glucose in the body rather than examining a specimen, so the MDR applies. A capillary blood glucose meter and strips supplied with it are IVDs under the IVDR.

Is the CGM app a separate medical device?

It depends on its function. Software that drives the sensor takes the class of the device under Section 3.3; standalone monitoring software is classified under Rule 11 in its own right, class IIa at least.

Can one authorised representative cover the EU and Türkiye?

Yes. Under the Commission Notice of March 2022, a manufacturer outside the EU and Türkiye only needs one authorised representative, either in the EU or in Türkiye.

Sources

Regulation (EU) 2017/745 on medical devices, consolidated text 10.01.2025 — eur-lex.europa.eu

Regulation (EU) 2017/746 on in vitro diagnostic medical devices — eur-lex.europa.eu

Regulation (EU) 2023/607 amending Regulation (EU) 2017/745 as regards transitional provisions — eur-lex.europa.eu

MDCG 2021-24 Rev.1, Guidance on classification of medical devices — health.ec.europa.eu

MDCG 2020-16 rev.5, Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 — health.ec.europa.eu

European Commission, Notice to Stakeholders: EU-Turkey Customs Union Agreement in the field of medical devices (March 2022) — health.ec.europa.eu

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Other device categories

We also cover dermal fillers, dental hand instruments, medical device software, examination and surgical gloves and kinesiology tape. The full list is on the device categories page, and country pages are in the list by country.

If your devices still need to be registered in EUDAMED, see our EUDAMED registration proposal.