EU labeling rules for medical devices

Claims about a medical device in the Union are bounded by the intended purpose for which conformity assessment was carried out, and Article 7 of Regulation (EU) 2017/745 prohibits any text, name, trade mark, picture or sign that may mislead the user or patient about intended purpose, safety or performance.¹ The particulars that must appear on the label, on sterile packaging and in the instructions for use are set out in Chapter III of Annex I, at Sections 23.1 to 23.4.¹

What may be claimed

Article 7 applies across the labelling, the instructions for use, the making available, the putting into service and the advertising of a device.¹ Four practices are prohibited. A manufacturer may not ascribe functions and properties to the device which it does not have, and may not create a false impression regarding treatment or diagnosis, functions or properties which the device does not have.¹ Failing to inform the user or the patient of a likely risk associated with use of the device in line with its intended purpose is itself a prohibited practice under point (c).¹

Point (d) is the provision that ties promotion to the conformity assessment. It prohibits suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.¹ The instructions for use carry the corresponding positive obligation: Section 23.4(b) requires the device’s intended purpose with a clear specification of indications, contra-indications, the patient target group or groups and the intended users, as appropriate.¹ Where applicable, Section 23.4(c) requires a specification of the clinical benefits to be expected, and Section 23.4(e) requires the performance characteristics of the device.¹

Products listed in Annex XVI, which fall within the Regulation by virtue of Article 1(2) and have no intended medical purpose, are treated differently. For those devices, Section 23.4(x) requires information regarding the absence of a clinical benefit and the risks related to use of the device.¹

General requirements for the information supplied

Section 23.1 states that each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user or any other person.¹ That information may appear on the device itself, on the packaging or in the instructions for use. Where the manufacturer has a website, the information must also be made available there and kept up to date.¹

The medium, format, content, legibility and location of the label and instructions for use must suit the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended users.¹ Instructions for use must be written in terms readily understood by the intended user. Where appropriate they are supplemented with drawings and diagrams.¹

Label information is required on the device itself. Where that is not practicable or appropriate, some or all of it may appear on the packaging for each unit or on the packaging of multiple devices.¹ Labels must be provided in a human-readable format and may be supplemented by machine-readable information such as radio-frequency identification or bar codes.¹ Residual risks that must be communicated to the user or another person are to be included as limitations, contra-indications, precautions or warnings.¹ Where appropriate, the information takes the form of internationally recognised symbols, and any symbol or identification colour used must conform to the harmonised standards or common specifications.¹ In areas where no harmonised standard or common specification exists, the symbols and colours are described in the documentation supplied with the device.¹

Information on the label

Section 23.2 sets out the particulars the label must bear. They are:

• the name or trade name of the device, together with the details strictly necessary for a user to identify the device and the contents of the packaging. Where it is not obvious, the intended purpose must also be given
• the name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business
• where the manufacturer’s registered place of business is outside the Union, the name of the authorised representative and the address of its registered place of business
• where applicable, an indication that the device contains or incorporates any of the following
  • a medicinal substance including a human blood or plasma derivative
  • tissues or cells of human origin or their derivatives
  • tissues or cells of animal origin or their derivatives as referred to in Regulation (EU) No 722/2012
• where applicable, information labelled in accordance with Section 10.4.5 of Annex I
• the lot number or serial number preceded by the words LOT NUMBER or SERIAL NUMBER or an equivalent symbol
• the UDI carrier referred to in Article 27(4) and Part C of Annex VI
• an unambiguous indication of the time limit for using or implanting the device safely, expressed at least in year and month where relevant, or otherwise the date of manufacture
• an indication of any special storage or handling condition that applies
• where the device is supplied sterile, an indication of its sterile state and the sterilisation method
• warnings or precautions that need to be brought to the immediate attention of the user or any other person
• an indication that the device is intended for single use, where that is the case, and a manufacturer’s indication of single use must be consistent across the Union
• for a reprocessed single-use device, an indication of that fact, the number of reprocessing cycles already performed and any limitation on the number of cycles
• the words “custom-made device” for a custom-made device, and the words “exclusively for clinical investigation” where the device is intended for clinical investigation only
• an indication that the device is a medical device
• for devices composed of substances or combinations of substances introduced into the body via a body orifice or applied to the skin and absorbed or locally dispersed, the overall qualitative composition and quantitative information on the main constituents responsible for the principal intended action
• the serial number for active implantable devices, and the serial number or lot number for other implantable devices.¹

Warnings on the label may be kept to a minimum, in which case more detailed information appears in the instructions for use, taking the intended users into account.¹

Information on sterile packaging

Section 23.3 lists the particulars that must appear on the packaging which maintains the sterile condition of a device. These are an indication permitting the sterile packaging to be recognised as such, a declaration that the device is in a sterile condition and the method of sterilisation.¹ The name and address of the manufacturer and a description of the device are also required. The month and year of manufacture must appear, together with an unambiguous indication of the time limit for using or implanting the device safely expressed at least in year and month.¹ The sterile packaging must carry an instruction to check the instructions for use for what to do if the packaging is damaged or unintentionally opened before use, and it must carry the words “exclusively for clinical investigations” or “custom-made device” where those apply.¹

Instructions for use

Instructions for use are provided together with devices.¹ Section 23.1(d) sets one exception: instructions for use are not required for class I and class IIa devices where those devices can be used safely without them, unless Section 23 provides otherwise elsewhere. Where multiple devices are supplied to a single user or location, a single copy may be provided if the purchaser agrees, and the purchaser may in any case request further copies free of charge.¹ Instructions may be supplied in non-paper format to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in subsequent implementing rules adopted under the Regulation.¹

Section 23.4 requires the instructions to repeat several label particulars.¹ They are those at points (a), (c), (e) and (f) of Section 23.2. They are also those at points (k), (l), (n) and (r) of the same section. The instructions must give any residual risks, contra-indications and undesirable side-effects, including information to be conveyed to the patient.¹ These come on top of the intended purpose, clinical benefits and performance characteristics already described. They must give the specifications the user requires to use the device appropriately, such as the degree of accuracy claimed for a measuring function, and details of any preparatory treatment or handling before or during use.¹ Requirements for special facilities, special training or particular qualifications of the user must be stated, as must the information needed to verify correct installation and readiness for safe use.¹

Further provisions address reuse and single use. For reusable devices, Section 23.4(n) requires information on the appropriate processes for reuse. Those processes include cleaning, disinfection and packaging. Where appropriate they include the validated method of re-sterilisation appropriate to the Member States concerned. The information also identifies when the device should no longer be reused.¹ Where the device bears a single-use indication, Section 23.4(p) requires information on known characteristics and technical factors that could pose a risk if the device were reused, drawn from a specific section of the risk management documentation.¹

The instructions must also cover safe disposal, the circumstances in which a lay user should consult a healthcare professional and, for devices incorporating electronic programmable systems or software that is a device in itself, the minimum requirements for hardware, IT network characteristics and IT security measures including protection against unauthorised access.¹ Each set of instructions carries its date of issue or, if revised, the date of issue and the identifier of the latest revision.¹ A notice must tell the user or patient that any serious incident in relation to the device should be reported to the manufacturer and to the competent authority of the Member State where the user or patient is established.¹ For implantable devices, the instructions carry the information to be supplied to the patient in accordance with Article 18 and the overall qualitative and quantitative information on materials and substances to which patients can be exposed.¹ Where applicable, they include links to the summary of safety and clinical performance referred to in Article 32.¹

The UDI carrier on the label

Article 27(4) requires UDI carriers to be placed on the label of the device and on all higher levels of packaging, and shipping containers are outside that obligation.¹ Before placing a device other than a custom-made device on the market, the manufacturer assigns a UDI to the device. Where applicable it also assigns a UDI to all higher levels of packaging. The UDI is created under the rules of a designated issuing entity.¹ The Basic UDI-DI appears on the EU declaration of conformity referred to in Article 19.¹

Article 123(3)(f) staged the application of Article 27(4) by class. It applied from 26 May 2021 for implantable and class III devices, from 26 May 2023 for class IIa and class IIb devices and from 26 May 2025 for class I devices.¹ A separate schedule in Article 123(3)(g) governs reusable devices that must bear the UDI carrier on the device itself. That obligation applied from 26 May 2023 for implantable and class III devices and from 26 May 2025 for class IIa and class IIb devices. For class I reusable devices it applies from 26 May 2027.¹

Devices still on the market under the former directives

Devices covered by Article 120(3a) may be placed on the market or put into service until 31 December 2027 for class III devices and for most class IIb implantable devices.¹ Other class IIb devices, class IIa devices and class I devices placed on the market sterile or with a measuring function may be placed on the market or put into service until 31 December 2028, and devices covered by Article 120(3b) may be placed on the market or put into service until 31 December 2028.¹ One condition in Article 120(3c)(a) is that those devices continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, so their labelling and instructions remain governed by the directive under which they were certified.¹ Another condition is that there are no significant changes in the design and intended purpose.¹ Article 120(3d) provides that the Regulation’s requirements on post-market surveillance, market surveillance, vigilance and registration of economic operators and devices apply to those devices in place of the corresponding directive requirements, and Article 123(3)(d) ties the application of Article 120(3d) to the date six months after publication of the notice referred to in Article 34(3).¹ Devices lawfully placed on the market before 26 May 2021, and those placed on the market under the transitional provisions, may continue to be made available or put into service.¹

Questions people also ask

Can a device be promoted for a use that falls outside its assessed intended purpose?

Article 7(d) prohibits suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.¹ The prohibition covers labelling, instructions for use, making available, putting into service and advertising, and it extends to text, names, trade marks, pictures and figurative or other signs.¹

When are instructions for use not required in the EU?

Section 23.1(d) of Annex I states that instructions for use are provided together with devices, with an exception for class I and class IIa devices that can be used safely without them, unless Section 23 provides otherwise elsewhere.¹ Where that exception applies, two pieces of information must still be made available to the user on request: the single-use reuse risk information under Section 23.4(p) and the safe disposal information under Section 23.4(v).¹

May instructions for use be supplied electronically?

Section 23.1(f) permits instructions for use in a non-paper format such as electronic form, to the extent and only under the conditions set out in Regulation (EU) No 207/2012 or in any subsequent implementing rules adopted under Regulation (EU) 2017/745.¹

Where must the UDI carrier appear on a device?

Article 27(4) requires the UDI carrier on the label of the device and on all higher levels of packaging, excluding shipping containers.¹ Section 23.2(h) of Annex I lists the UDI carrier among the particulars the label must bear.¹ Reusable devices that are required to bear the UDI carrier on the device itself follow the separate dates in Article 123(3)(g).¹

What must a label say about sterility and single use?

Where a device is supplied sterile, Section 23.2(l) requires an indication of its sterile state and the sterilisation method.¹ Where the device is intended for single use, Section 23.2(n) requires an indication of that fact, and the manufacturer’s indication of single use must be consistent across the Union.¹ A reprocessed single-use device must bear an indication of that fact, the number of reprocessing cycles already performed and any limitation on the number of cycles.¹

Footnotes

1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Consolidated version of 2026-07-19. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20260719 ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸ ↩⁹ ↩¹⁰ ↩¹¹ ↩¹² ↩¹³ ↩¹⁴ ↩¹⁵ ↩¹⁶ ↩¹⁷ ↩¹⁸ ↩¹⁹ ↩²⁰ ↩²¹ ↩²² ↩²³ ↩²⁴ ↩²⁵ ↩²⁶ ↩²⁷ ↩²⁸ ↩²⁹ ↩³⁰ ↩³¹ ↩³² ↩³³ ↩³⁴ ↩³⁵ ↩³⁶ ↩³⁷ ↩³⁸ ↩³⁹ ↩⁴⁰ ↩⁴¹ ↩⁴² ↩⁴³ ↩⁴⁴ ↩⁴⁵ ↩⁴⁶ ↩⁴⁷ ↩⁴⁸ ↩⁴⁹ ↩⁵⁰ ↩⁵¹ ↩⁵² ↩⁵³ ↩⁵⁴ ↩⁵⁵ ↩⁵⁶ ↩⁵⁷ ↩⁵⁸ ↩⁵⁹