CE Marking for Medical Devices under MDR and IVDR: Steps

CE marking for medical devices and IVDs: the six steps, the 5 mm Annex V format, when the notified body number follows, and which devices carry none.

Custom-made devices, investigational devices and devices for performance studies bear none, except CE-marked devices used in post-market follow-up studies.

Manufacturers or their authorised representatives affix the marking; importers and distributors verify it, with the EU declaration of conformity, before they supply the device.

This page covers what the marking means, which devices bear it, the six steps to it, the Annex V format, the notified-body number, who affixes and checks it, and how long Directive markings stay valid.

What the CE Marking Means

The CE marking on a medical device or IVD is the manufacturer's statement that the device conforms to the applicable requirements of the MDR or the IVDR and of any other Union law that provides for the marking; it is a declaration by the manufacturer, not a certificate.

Where a notified body takes part, it issues a certificate, but the CE marking stays the manufacturer's own statement. Both regulations entered into force on 25 May 2017; the MDR has applied since 26 May 2021 and the IVDR since 26 May 2022, directly in every member state. How the marking fits into the framework of the EU MDR and IVDR is explained on the home page.

The Definition of the CE Marking in Both Regulations

MDR Article 2(43) and IVDR Article 2(35) define the CE marking of conformity in the same words: "a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing".

The operative rules sit in MDR Article 20 and Annex V and in IVDR Article 18 and Annex V. MDR Article 10(6) obliges manufacturers of devices other than custom-made or investigational devices to draw up the EU declaration of conformity and affix the marking after the applicable conformity assessment; IVDR Article 10(5) does the same for devices other than devices for performance study. On IVDs the marking is often called "CE-IVD"; the IVDR term is "CE marking of conformity".

One Marking for Every Union Act That Requires It

Where other Union legislation also provides for the CE marking, the single CE marking on the device indicates conformity with that legislation too (MDR Article 20(6), IVDR Article 18(6)). MDR Article 20 sits in Chapter II of the EU MDR (Regulation (EU) 2017/745).

Which Devices Bear the CE Marking and Which Do Not

Every device placed on the market under the MDR or the IVDR bears the CE marking, except custom-made devices, investigational devices and devices for performance studies, which bear none unless they are already CE-marked devices used in a post-market clinical or performance follow-up study. The MDR exception covers post-market clinical follow-up (PMCF) investigations under MDR Article 74; the IVDR exception covers post-market performance follow-up (PMPF) studies under IVDR Article 70. The table lists the six situations.

Device	CE marking	Legal basis	Topic page
Custom-made device	no (Annex XIII statement instead)	MDR Article 20(1), Article 21(1)	custom-made devices
Investigational device	no	MDR Article 20(1), Article 21(1)	clinical investigations under the MDR
CE-marked device in a PMCF investigation	yes, already CE marked	MDR Article 74	PMCF under the MDR
Device for performance study	no	IVDR Article 18(1), Article 19(2)	IVDR performance studies
CE-marked IVD in a PMPF study	yes, already CE marked	IVDR Article 70	PMPF under the IVDR
Device under a national derogation	no CE marking created by the authorisation	MDR Article 59, IVDR Article 54	children index below

A device can also be used without the CE marking under a national derogation: a competent authority may authorise, within its territory, a specific device without a completed conformity assessment, in the interest of public health or patient safety or health (MDR Article 59(1), IVDR Article 54(1)). The authorisation creates no CE marking.

The Six Steps from Scope Check to the CE Mark

A manufacturer reaches the CE marking in six steps: confirm that the product is a medical device or an IVD, determine its class, meet Annex I and document it, complete the conformity assessment route for that class, draw up the EU declaration of conformity and register in EUDAMED, and affix the marking before the device is placed on the market.

The steps are the same under both regulations; the class rules and routes differ. The IVD-specific rules are set out in the IVDR (Regulation (EU) 2017/746).

Step	What happens	MDR	IVDR	Topic pages
1 Scope	qualify the product against the definitions; the intended purpose decides	Article 2(1)	Article 2(2)	what is a medical device; what is an in vitro diagnostic medical device
2 Class	apply the Annex VIII rules	22 rules, classes I to III (Article 51)	7 rules, classes A to D (Article 47)	MDR classification; IVDR classification
3 Requirements and file	meet Annex I; document Annexes II and III	Article 10(4)	Article 10	GSPR of Annex I; MDR and IVDR technical documentation
4 Conformity assessment	self-certification or notified body, by class	Article 52	Article 48	MDR conformity assessment; IVDR conformity assessment; notified body fees and timelines
5 Declaration and registration	EU declaration of conformity; actor and device registration	Articles 10(6), 19, 29, 31	Articles 10(5), 17, 26, 28	EUDAMED under the MDR and IVDR
6 Affixing	Annex V format, before placing on the market	Article 20	Article 18	Annex V section below

Step 1: Confirm the Product Is a Device in Scope

The CE marking route starts with qualification: the product must meet the medical device definition of MDR Article 2(1) or the IVD definition of IVDR Article 2(2), and the manufacturer's intended purpose decides which. Under MDR Article 2(12) and IVDR Article 2(12), the intended purpose follows from the manufacturer's label, instructions for use and promotional or sales materials.

Step 2: Determine the Risk Class

The class decides whether a notified body is involved: the MDR sorts devices into classes I, IIa, IIb and III under 22 rules in Annex VIII, and the IVDR into classes A, B, C and D under seven rules in its Annex VIII. MDR Article 51(1) and IVDR Article 47(1) set the classes. MDR class I has three sub-types that change the marking: sterile (Is), measuring (Im) and reusable surgical instruments (Ir).

Step 3: Meet Annex I and Build the File

The device must meet the general safety and performance requirements of Annex I, and the manufacturer must draw up and keep up to date technical documentation with the elements of Annexes II and III (MDR Article 10(4)). IVDR Article 10 sets the parallel duty. MDR Annex I has three chapters: general requirements (Sections 1 to 9), design and manufacture (Sections 10 to 22), and label and instructions for use (Section 23).

Step 4: Complete the Assessment Route for the Class

Class I devices under the MDR and class A devices under the IVDR are self-certified: the manufacturer draws up the technical documentation and the EU declaration of conformity without a notified body, except for sterile, measuring and reusable aspects (MDR Article 52(7), IVDR Article 48(10)).

Higher classes need a notified body: MDR class III (Article 52(3)), IIb (Article 52(4)) and IIa (Article 52(6)), and IVDR class D (Article 48(3) to (6)), C (Article 48(7) and (8)) and B (Article 48(9)). For class D, where an EU reference laboratory is designated, the notified body requests its verification of the claimed performance and of compliance with the common specifications (IVDR Article 48(5)).

Step 5: Sign the Declaration and Register in the Database

Before affixing the CE marking, the manufacturer draws up an EU declaration of conformity with the minimum content of Annex IV and, by doing so, assumes responsibility for the device's compliance (MDR Articles 10(6) and 19, IVDR Articles 10(5) and 17).

Manufacturers register as actors (MDR Article 31(1), IVDR Article 28) and register their devices (MDR Article 29, IVDR Article 26). Four EUDAMED modules have been mandatory since 28 May 2026 under Commission Decision (EU) 2025/2371, as of 6 November 2026.

Step 6: Affix the Mark Before the First Unit Is Supplied

The CE marking is affixed before the device is placed on the market (MDR Article 20(4), IVDR Article 18(4)), and placing on the market means the first making available of a device on the Union market (MDR Article 2(28), IVDR Article 2(21)).

CE Marking in Detail: Declaration, Derogation and Free Sale

Three detailed pages cover what this overview summarises: the EU declaration of conformity and its 10 Annex IV items, the national derogation that allows a specific device without a completed conformity assessment, and the certificate of free sale issued for export.

Page	What it answers	Legal hook
EU declaration of conformity for medical devices and IVDs	the 10 Annex IV items and the template structure	MDR Article 19, IVDR Article 17, Annex IV
derogation from conformity assessment	national special authorisation and Union-wide extension	MDR Article 59, IVDR Article 54
certificate of free sale for medical devices	export certificate issued by the member state on request	MDR Article 60, IVDR Article 55

Annex V: Format, Size and Placement of the CE Marking

Annex V of both regulations fixes the form of the CE marking: the graduated drawing, kept in proportion when reduced or enlarged, and at least 5 mm high.

The 5 mm Minimum and the Graduated Drawing

The CE marking must be at least 5 mm high (MDR and IVDR Annex V point 3), and the proportions of the graduated drawing must be respected when it is reduced or enlarged (Annex V point 2).

The 5 mm minimum may be waived for small-scale devices (Annex V point 3). The minimum, the waiver and the proportion rule are the same for a medical device under the MDR and for an IVD under the IVDR.

Where the Marking Goes on the Device and Its Packaging

The CE marking is affixed visibly, legibly and indelibly to the device or its sterile packaging, and only where that is not possible or not warranted on the packaging (MDR Article 20(3), IVDR Article 18(3)). It also appears in any instructions for use and on any sales packaging. The other label particulars are covered under medical device labelling under the MDR and IVDR.

The CE marking may be followed by a pictogram or any other mark indicating a special risk or use (MDR Article 20(4), IVDR Article 18(4)).

When the Notified Body Number Follows the CE Marking

The CE marking is followed by the identification number of the notified body responsible for the conformity assessment only where a notified body was involved (MDR Article 20(5), IVDR Article 18(5)).

The four-digit number is assigned by the Commission and public in NANDO (MDR Article 43(1) and (2)). How bodies are designated and searched is set out under notified bodies for the MDR and IVDR. The table gives the rule for each of the 10 classes and sub-types.

Class	Notified body involved	Number after the CE marking	Legal basis	Topic page
MDR class I (non-sterile, no measuring function, not reusable)	no	no	MDR Article 52(7)
MDR class Is, Im, Ir	yes, limited to sterility, metrology or reuse	yes	MDR Article 52(7); MDCG 2019-15 rev.1 step 6	class I medical devices under the MDR
MDR class IIa	yes	yes	MDR Article 52(6)
MDR class IIb	yes	yes	MDR Article 52(4)
MDR class III	yes	yes	MDR Article 52(3)
IVDR class A (non-sterile)	no	no	IVDR Article 48(10)
IVDR class A sterile	yes, limited to sterility	yes	IVDR Article 48(10)
IVDR class B	yes	yes	IVDR Article 48(9)
IVDR class C	yes	yes	IVDR Article 48(7), (8)
IVDR class D	yes, with EU reference laboratory verification where designated	yes	IVDR Article 48(3) to (6)	EU reference laboratories for class D IVDs

Self-Certified Devices Carry No Number

Class I MDR devices that are not sterile, have no measuring function and are not reusable surgical instruments, and non-sterile class A IVDs, carry the CE marking without any notified-body number. MDR Article 20(5) and IVDR Article 18(5) tie the number to the notified body responsible for the assessment, so a device assessed by its manufacturer alone has no number to show.

Limited Assessments: Sterile, Measuring and Reusable Devices

Class Is, Im and Ir devices under the MDR and sterile class A devices under the IVDR carry the notified-body number, although the notified body assesses only the sterility, metrology or reuse aspects (MDR Article 52(7), IVDR Article 48(10)).

The class I guidance MDCG 2019-15 rev.1 (July 2020) explains in its step 6 that the CE marking of class Is, Im and Ir devices is accompanied by the notified body's number; MDCG guidance is not legally binding (MDR Articles 103 and 105, IVDR Articles 98 and 99). The pending proposal COM(2025) 1023 (stage below) would drop notified-body involvement for class I reusable surgical instruments where harmonised standards or common specifications covering all relevant aspects are applied.

The Number in Promotional Material

Any promotional material that mentions that a device fulfils the requirements for the CE marking must also carry the notified body's identification number (MDR Article 20(5), IVDR Article 18(5)).

Who Affixes the CE Marking and Who Checks It

Only the manufacturer or its authorised representative affixes the CE marking, while importers and distributors verify it before they supply the device. Each role is set out under economic operators under the MDR and IVDR.

Role	Duty on the CE marking	Legal basis
manufacturer obligations	affixes it after the conformity assessment and the declaration	MDR Article 10(6), IVDR Article 10(5); Regulation (EC) No 765/2008 Article 30(1)
EU authorised representative	may affix it for the manufacturer	Regulation (EC) No 765/2008 Article 30(1)
importer obligations	verifies CE marking and declaration before placing on the market	MDR Article 13(2)(a); IVDR Article 13
distributor obligations	verifies CE marking and declaration before making available	MDR Article 14(2)(a); IVDR Article 14; Case C-10/24
market surveillance of medical devices	competent authorities check devices on the market	MDR Articles 93 to 100, IVDR Articles 88 to 95

The Manufacturer or Its Authorised Representative

Regulation (EC) No 765/2008 Article 30(1) reserves the affixing of the CE marking to the manufacturer or its authorised representative, and MDR Article 10(6) and IVDR Article 10(5) tie it to the completed conformity assessment and the EU declaration of conformity. Regulation (EC) No 765/2008 has been in force since 2 September 2008 (consolidated version of 16 July 2021).

Importer and Distributor Checks

Before supplying a device, importers and distributors verify two points under the MDR, and IVDR Articles 13 and 14 set their obligations for IVDs:

the device has been CE marked (MDR Article 13(2)(a) for importers before placing on the market, Article 14(2)(a) for distributors before making available);
the EU declaration of conformity has been drawn up (same provisions).

In Case C-10/24, judgment of 4 June 2026 (ECLI:EU:C:2026:443), the Court of Justice held that a distributor, as part of due care, verifies in the light of the information at its disposal whether the CE marking and the declaration clearly concern a device within the MDR, without a duty to verify the class IIa classification.

Misleading Marks and Penalties

Markings likely to mislead third parties about the meaning or form of the CE marking are prohibited, while other markings are allowed if they do not impair its visibility, legibility and meaning (Regulation (EC) No 765/2008 Article 30(5)). Under Article 30(6), member states provide penalties for infringements, which may include criminal sanctions for serious infringements.

Directive CE Markings That Remain Valid for a Limited Time

A legacy device, one with a valid certificate under the old Directives or a self-declared device that needs a notified body under the MDR, may keep its Directive CE marking and be placed on the market or put into service until 31 December 2027 (class III, and class IIb implantable except the items listed in MDR Article 120(3a)(a)) or 31 December 2028 (all others), provided the conditions of MDR Article 120(3c) are met: continued compliance with the Directive, no significant change, no unacceptable risk, a quality management system by 26 May 2024, and a notified-body application by 26 May 2024 with a written agreement by 26 September 2024. The dates come from Regulation (EU) 2023/607; the conditions are set out under the MDR transition period.

Commission proposal COM(2025) 1023 of 16 December 2025 (procedure 2025/0404(COD)) is pending, not law: as of 6 November 2026 it is at the stage "Awaiting committee decision" in the European Parliament's SANT committee, and its past procedural events include the draft report of 30 June 2026. The proposal would allow legacy devices meeting the orphan-device criteria to be placed on the market after the end dates without a valid certificate, but without the CE marking.

Legacy IVDs follow IVDR Article 110 as amended by Regulation (EU) 2024/1860, by class, with a quality management system required by 26 May 2025:

31 December 2027 for devices with an IVDD certificate and self-declared devices now in class D;
31 December 2028 for self-declared devices now in class C;
31 December 2029 for self-declared devices now in class B and sterile class A.

A CE marking on an IVD can therefore rest on an IVDD declaration or certificate or on an IVDR conformity assessment, and both are lawful until the Article 110 dates. The class dates are set out under the IVDR transition periods.

What the CE Marking Is Not

The CE marking is a key indicator of a device's compliance, not proof of it, not a sign of European origin and not a marketing tool (Blue Guide 2022, Section 4.5.1.1). The Blue Guide is Commission Notice 2022/C 247/01 on the implementation of EU product rules, published on 29 June 2022.

Is a CE Marking Proof That a Device Is Safe?

No: the Commission's Blue Guide describes the CE marking as a key indicator, but not proof, of compliance, and market surveillance authorities can still check the device. Competent authorities do so under MDR Articles 93 to 100 and IVDR Articles 88 to 95.

Can a CE Marking Be Shown Only Electronically?

No: the Blue Guide 2022 (Section 4.5.1.4) does not allow a CE marking affixed only electronically; the regulations require it on the device or its packaging (MDR Article 20(3), IVDR Article 18(3)).

Does the CE Marking Show That a Device Was Made in the EU?

No: the CE marking does not indicate EU origin (Blue Guide 2022, Section 4.5.1.1); devices made outside the Union carry it once they conform.

CE Marking for Medical Devices and IVDs: The Steps from Classification to the CE Mark and the Notified Body Number

Summary