CE marking, frequently asked questions

Hugues Orgitello updated 7 Oct 2026 20 min read

Twenty-two questions that come up in almost every CE marking project, each answered from the text that settles it: Regulation 765/2008, Decision 768/2008, the RED, EMC and LVD directives, Regulation 2019/1020 and the Commission Blue Guide (2022 edition), as they stand on 7 October 2026. Where the texts say nothing, as on prices and lead times, this page says so instead of guessing. The questions are grouped in seven themes, followed by a table of dates and the claims the texts contradict.

Legal status of CE marking

Is CE marking a certification?

No. Under Article 30(3) of Regulation 765/2008, by affixing or having affixed the CE marking, the manufacturer indicates that it takes responsibility for the conformity of the product with all applicable requirements. No authority or body "issues" it.

Whether a third party is involved depends on the conformity assessment procedure the act allows. The modular conformity assessment guide has the detail; the cases that matter for electronics:

Act	Notified body involvement	Text
LVD 2014/35/EU	None: internal production control only	Article 6(2), Annex III
EMC Directive 2014/30/EU	Optional: EU-type examination (module B) if the manufacturer chooses it	Article 14
RED 2014/53/EU	Article 3(1): never mandatory. Article 3(2) and 3(3): module B + C or H when cited harmonised standards were not applied in full, or do not exist	Article 17
ATEX 2014/34/EU	Categories 1 and 2 involve a notified body; category 3 is internal production control	Article 13
MDR 2017/745	From class IIa, and for class I sterile, measuring or reusable surgical devices	Article 52

For a typical connected product under the RED and RoHS, applying the cited harmonised standards in full keeps the whole assessment under module A (see Procedure).

Who can affix the CE marking?

Only the manufacturer or its authorised representative may affix it (Regulation 765/2008, Article 30(1)). The representative does so on the manufacturer's behalf if its written mandate covers that task: the Blue Guide (section 3.2) lists drawing up and signing the DoC and affixing the CE marking among tasks that can be mandated. What cannot be mandated is design and manufacture and drawing up the technical documentation (RED Article 11(1), EMC Article 8(1)). See authorised representative and importer obligations.

The importer does not affix the marking; before placing the product on the market it must ensure that the conformity assessment was carried out and that the product bears the CE marking and is accompanied by the required documents (RED Article 12(2)). The distributor verifies the same before making the product available (Article 13(2)).

For private label, Article 14 of the RED makes an importer or distributor the manufacturer when it places the product on the market under its own name or trademark. The company whose name is on the product carries the full responsibility and must hold the documentation, which need not be in its name but must cover the product (Blue Guide, section 3.1; see CE scope).

Costs and lead times

How much does CE marking cost?

No EU act sets a price for CE marking. Under module A no fee is paid to any authority. Lab and notified body fees are set by contract and quoted per product. The earlier version of this page gave budget ranges per test family and per project; none of them came from a source, and they have been removed. The certification costs page lists the fees that regulators and programmes do publish; for CE testing, budget from quotes for your product.

How long does it take to obtain CE marking?

The acts set no duration for module A. The CE marking is affixed "before the radio equipment is placed on the market" (RED Article 20(2); EMC Article 17(2) for apparatus), once the conformity assessment is complete. When a notified body is involved, its timing is a matter of contract. The lead time figures the earlier version of this page gave had no source and have been removed.

What the texts do fix is the date that freezes the applicable rules: the placing on the market of each unit, not the launch of the model (Blue Guide, section 2.3). A model on sale before a new requirement applies must meet it for every unit placed on the market afterwards.

Geographic scope

What happens after Brexit for the United Kingdom?

In Great Britain, The Product Safety and Metrology etc. (Amendment) Regulations 2024 (SI 2024/696), in force on 1 October 2024, revoked the expiry of CE recognition for most regimes, including EMC, low voltage, radio, machinery, RoHS and ecodesign. UKCA marking is optional for them, and Fast-Track UKCA lets it rest on the EU evidence. Two conditions are often missed: the EU declaration and the technical documentation must be in or translated into English, and for radio equipment a notified body procedure is required where no UK designated standard corresponds to the harmonised standard relied on.

Sectors with their own rules include medical devices: CE-marked devices are accepted in Great Britain until 30 June 2028 (MDD, AIMDD) or 30 June 2030 (IVDD, EU MDR, EU IVDR), and a consultation on indefinite recognition opened on 16 February 2026.

Northern Ireland applies Union harmonisation legislation under the Windsor Framework: CE, or CE + UKNI when a UK-based Northern Ireland notified body carried out the mandatory assessment. The detail is in the UKCA vs CE comparison.

Does Switzerland accept CE marking?

Switzerland is neither in the EEA nor in a customs union with the EU. The EU and Switzerland Mutual Recognition Agreement (MRA), in force since 1 June 2002, rests on Switzerland aligning its legislation in the sectors it covers; certificates from conformity assessment bodies on each side are recognised within that scope. The Blue Guide (section 9.2.2) lists twenty sectors, among them machinery, electrical safety and EMC, telecommunications terminal equipment, ATEX, pressure equipment, toys, and only partially medical devices. Market access in Switzerland is governed by Swiss law: check the sector your product falls under. The earlier version of this page named Swiss bodies and a "gradual erosion since 2021" without a source; those statements have been removed.

Standards and tests

Is the "China Export" marking a CE marking?

No. In 2007 a Member of the European Parliament asked about a "China Export" mark resembling the CE marking with the letters closer together (question P-5938/2007). In its answer of March 2008, the Commission said it was not aware of the existence of a "China export mark" and considered that the mark in question was the CE marking "without, however, respecting the dimensions and proportions prescribed therein". The detail is in CE marking dimensions and visual rules.

What the texts define is the CE marking itself:

• one graphic form, the initials "CE" as drawn in Annex II of Regulation 765/2008, with the proportions of the graduated drawing kept when reduced or enlarged;
• at least 5 mm high, where the specific act imposes no other dimension (Annex II, point 3; the Blue Guide, section 4.5.1, notes that some acts waive the minimum for small devices);
• affixed visibly, legibly and indelibly (Decision 768/2008, Article R12).

Article 30(5) prohibits markings, signs or inscriptions "likely to mislead third parties regarding the meaning or form of the CE marking". A CE marking that does not follow the graduated drawing is a formal non-compliance (for example RED Article 43, EMC Article 40, LVD Article 22), whatever meaning is claimed for it, and a misleading imitation is itself prohibited.

What if a harmonised standard is withdrawn during marketing?

Applying harmonised standards is voluntary (Blue Guide, section 4.1.2.3), and presumption of conformity comes from the reference published in the OJ. When a revised standard is cited, the Commission sets a date for withdrawing the superseded reference; until then both editions give presumption. After that date, only the revised edition does (Blue Guide, section 4.1.2.5).

For units placed on the market after the withdrawal date, the manufacturer has two routes:

1. Apply the revised edition and update the tests and declaration it affects.
2. Keep the old edition as another specification and demonstrate in the technical file, in more detail, how it meets the essential requirements (Blue Guide, section 4.1.3). Presumption is lost on that route.

The Blue Guide also asks manufacturers to keep track of changes in the state of the art and assess whether the changes in the revised standard are material for their product. Units already placed on the market are not affected. How to find the current reference: Standards and harmonised standards and presumption of conformity.

Can I use a CB Scheme report for CE conformity?

The CB Scheme, run by the IECEE, is a scheme for the mutual acceptance of test reports against IEC standards. EU law does not mention it. What the EU texts say:

• Under module A, the technical documentation must contain test reports, but the texts do not say who performs the tests. A CB test report can be one of them.
• Presumption of conformity comes from applying the EN edition cited in the OJ. Under the LVD, the cited edition for audio, video and ICT equipment is EN 62368-1:2014 with AC:2015 (see CE tests). A report to another IEC or EN edition is "another specification": the technical file has to show how it meets the essential requirements (Blue Guide, section 4.1.3).
• For radio equipment, the RED list cites no general electrical safety standard, so a safety report supports an assessment against Article 3(1)(a) rather than a presumption from the RED list.

Sub-assemblies and modifications

Does a Wi-Fi module already CE-marked exempt me from RED marking for my final product?

No. The Blue Guide (section 2.1) states that when a finished product incorporating another product is placed on the market, its manufacturer is responsible for the compliance of the complete product, and that "the fact that components or parts are CE marked does not automatically guarantee that the finished product also complies". The same section allows the manufacturer of the finished product to "rely on the conformity assessment of the integrated product" when building its own declaration, assessment and documentation.

The RED assesses the finished radio equipment, including where it must be completed with an accessory such as an antenna (Article 2(1)(1)), and in all possible configurations (Article 17(1)). Whether module test results remain valid in the host is a technical question about antenna, layout and power supply, which the file has to answer. The Wi-Fi or BLE module evidence goes into the file, with the integration conditions it was obtained under. See also Common pitfalls.

Do I need to redo CE marking after a software update?

Not as a rule. The Blue Guide (section 2.1) treats software updates like physical changes: a product is substantially modified, and becomes a new product, only where all three conditions are met:

1. the update modifies the original intended functions, type or performance in a way not foreseen in the initial risk assessment;
2. the nature of the hazard has changed or the level of risk has increased;
3. the product is made available (or put into service, where the act covers it).

Otherwise the update counts as maintenance. Independently of this test, the manufacturer must keep series production in conformity and take into account changes in design or characteristics (RED Article 10(5)), and the technical documentation must reflect all versions of the product placed on the market (Blue Guide, section 4.3).

How do I handle an OTA update that modifies radio firmware?

The same Blue Guide test applies. Two RED provisions make firmware visible in the file:

• Annex V(a)(ii): the technical documentation describes "versions of software or firmware affecting compliance with essential requirements";
• Annex VI, point 8, and Article 10(8): the DoC and the instructions describe accessories, components and software that allow the equipment to operate as intended, where applicable.

A firmware version that changes a parameter assessed under Article 3(2), such as transmitted power or frequency bands, has to be assessed against the cited standard before units carrying it are placed on the market, and the DoC updated where its content changes. For units already with end users, the test of section 2.1 decides whether the update creates a new product.

What happens for spare parts and accessories?

Repairs. A product repaired with a spare part identical or similar to the original is not a new product and does not undergo conformity assessment again, even if the spare part performs better through technical progress (Blue Guide, section 2.1).

Parts sold on their own. Within a given act, components, spare parts or sub-assemblies may themselves be finished products, which must comply when first supplied (Blue Guide, section 2.1). Two common cases:

• an external mains power supply sold separately is electrical equipment under the LVD and apparatus under the EMC Directive;
• a replacement battery falls under the Batteries Regulation 2023/1542, which has its own conformity assessment (Article 17, applicable since 18 August 2024 under Article 96) and CE marking (Articles 19 and 20). The earlier version of this page cited EN 62133 as a requirement; harmonised standards are voluntary, and the obligation comes from the Regulation.

Consumer spare parts outside any harmonisation act remain subject to general product safety (Blue Guide, footnote 37).

Online sales and obligations

Must the CE marking appear in the user manual?

No. Article R12 of Decision 768/2008 requires the CE marking on the product or its data plate; where the nature of the product does not allow or warrant that, it goes on the packaging and accompanying documents, where the act provides for it. The RED also requires it "visibly and legibly" on the packaging (Article 20(1)).

What a radio product must ship with is the DoC: a copy of the full declaration or a simplified DoC containing "the exact internet address where the full text of the EU declaration of conformity can be obtained" (RED Article 10(9) and Annex VII). The technical file page gives the Annex VII wording.

Instructions must be in a language "which can be easily understood by consumers and other end-users, as determined by the Member State concerned" (RED Article 10(8)). In France, Law No 94-665 of 4 August 1994 (Article 2) makes French mandatory in the instructions for use of goods.

Can I sell my product online without an authorised representative in the EU?

Yes, if another operator established in the Union carries the tasks. Since 16 July 2021, Article 4 of Regulation 2019/1020 requires that a product under the acts listed in Article 4(5) (including the RED, EMC Directive, LVD, RoHS and the Machinery Directive) is placed on the market only if an economic operator established in the Union is responsible for it. That operator is:

1. a manufacturer established in the Union;
2. an importer, where the manufacturer is not established in the Union;
3. an authorised representative with a written mandate;
4. a fulfilment service provider established in the Union, for the products it handles, where none of the above is established in the Union.

Its name and contact details, postal address included, go on the product, its packaging, the parcel or an accompanying document (Article 4(4)).

Marketplaces. The Digital Services Act applies to online platforms that let consumers conclude distance contracts with traders, except micro and small enterprises not designated as very large platforms (Article 29). Before a trader can sell, the platform must collect its identity, contact, payment and registration details and a self-certification of compliance with Union law, and make best efforts to assess whether they are reliable (Article 30); its interface must let traders display the information that product law requires (Article 31). The earlier version of this page said the platform checks the economic operator and that platforms had been sanctioned in 2024 and 2025; neither statement had a source.

What if my product is defective after placing on the market?

The obligations come from the sector act. A manufacturer who considers or has reason to believe that a product it placed on the market is not in conformity must:

• immediately take the corrective measures necessary to bring it into conformity, withdraw it or recall it, if appropriate;
• where the product presents a risk, immediately inform the competent national authorities of the Member States where it was made available, with details of the non-compliance and the corrective measures taken.

These are RED Article 10(11), EMC Article 7(8) and LVD Article 6(8). The Article 4 operator of Regulation 2019/1020 must inform the market surveillance authorities when it has reason to believe the product presents a risk, and ensure corrective action is taken (Article 4(3)(c) and (d)). Traceability rests on the type, batch or serial number on the product (RED Article 10(6)) and on the duty to identify, for 10 years, any economic operator who supplied or was supplied (RED Article 15). The product recall guide covers the Safety Gate side.

My product is only for professional use, am I exempt from CE marking?

No. The EMC Directive, LVD, RED and RoHS apply to the products in their scope whether they are sold to consumers or to businesses; exclusions are specific and listed in each act (see CE scope). Professional use has one direct consequence under the EMC Directive: apparatus for which compliance is not ensured in residential areas "shall be accompanied by a clear indication of such restriction of use, where appropriate also on the packaging" (Article 18(2)). The Class A and Class B limits themselves come from the harmonised standard, for example EN 55032 for multimedia equipment, not from the Directive (see CE tests).

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Special cases

How do I handle a product covered by multiple directives?

All applicable acts apply together, and one CE marking covers them all (Regulation 765/2008, Article 30(3)). For radio equipment, the RED takes over: it excludes the LVD except as set out in Article 3(1)(a) (Article 1(4)), and the EMC Directive excludes equipment the RED covers (Article 2(2)(a)). A Wi-Fi product therefore declares the RED and RoHS, not the RED, LVD and EMC Directive together.

The declaration rule is the same in RED Article 18(3) and in Article 15(3) of the EMC Directive and LVD: where a product is subject to more than one act requiring an EU declaration of conformity, "a single EU declaration of conformity shall be drawn up in respect of all such Union acts", identifying each with its publication reference. Recital 42 of the RED allows that single declaration to be a dossier made up of the individual declarations. REACH, WEEE and the GDPR are not CE marking acts and do not belong in it (see technical file).

How does CE marking work for a product with eSIM?

A product with a cellular modem intentionally emits and receives radio waves, so it is radio equipment under RED Article 2(1)(1), assessed and CE marked as a whole. The eSIM inside it is not a separate product with its own marking. For Article 3(2), the RED list cites parts of EN 301 908 for cellular user equipment (see CE tests).

No EU text treats a change of operator profile on the eSIM as a modification of the product in itself. Whether a remote change creates a new product is decided by the Blue Guide test for software updates (section 2.1). The earlier version of this page stated that profile changes never affect the assessed parameters; no text says that.

What must I include in the user manual beyond operating instructions?

For radio equipment, the RED sets the list. The table gives each item and where it may go.

Item	Where	Text
Instructions and safety information, in a language set by the Member State	Accompanying the product	RED Article 10(8)
Frequency bands and maximum radio-frequency power transmitted, for transmitters	Instructions	RED Article 10(8)(a) and (b)
Accessories and components, including software, that allow the equipment to operate as intended	Instructions, where applicable	RED Article 10(8)
Copy of the DoC, or simplified DoC with the exact internet address	Accompanying each item	RED Article 10(9)
Restrictions on putting into service or authorisation of use	Packaging, completed in the instructions	RED Article 10(10)
Manufacturer name and postal address	Product, or packaging or accompanying document if not possible	RED Article 10(7)
Importer name and postal address	Product, or packaging or accompanying document if not possible	RED Article 12(3)
Article 4 operator name and contact details	Product, packaging, parcel or accompanying document	Regulation 2019/1020, Article 4(4)
Type, batch or serial number	Product, or packaging or accompanying document if not possible	RED Article 10(6)
Crossed-out wheeled bin symbol	Product	WEEE Directive 2012/19/EU, Article 14(4) and Annex IX

For apparatus under the EMC Directive alone, Article 18 asks for any specific precautions for assembly, installation, maintenance or use, and the residential restriction where it applies.

What is the scope of CE marking compared to GDPR?

The GDPR (Regulation 2016/679) is not a CE marking act: it governs processing of personal data, and the CE marking says nothing about it (see CE scope).

The overlap comes from RED Article 3(3)(e), which requires radio equipment to incorporate safeguards to protect the personal data and privacy of the user. Delegated Regulation 2022/30 activated it, with points (d) and (f), from 1 August 2025, for internet-connected radio equipment, childcare radio equipment, toys and wearables that can process personal data. The cited standard for (e) is EN 18031-2:2024, with restrictions (Decision (EU) 2025/138). The Delegated Regulation is repealed from 11 December 2027, when the Cyber Resilience Act applies in full. Meeting 3(3)(e) does not replace GDPR compliance for the data the product actually processes.

How long must I retain the technical file?

10 years after the product has been placed on the market: EMC Article 7(3), LVD Article 6(3), RED Article 10(4), RoHS Article 7(d); at least 10 years for machinery under Regulation 2023/1230 (Article 10(3)). The Blue Guide (section 4.3) counts from each individual product placed on the market, so from the last unit: a model sold from 2020 to 2024 keeps its file until 2034.

The texts leave the archive format to the manufacturer; the documentation must be supplied on reasoned request, "in paper or electronic form" (EMC Article 7(9)). For a manufacturer outside the EU, the Article 4 operator of Regulation 2019/1020 must keep the DoC available and ensure the technical documentation can be supplied (Article 4(3)(a)); an authorised representative keeps both at the disposal of the authorities when its mandate covers it (RED Article 11(2)(a)). The earlier version of this page added that 15 to 20 years of retention is common; no source supported it.

Dates behind these answers

Date	Change	Text
16 July 2021	Article 4 economic operator required for products under the acts in Article 4(5)	Regulation 2019/1020, Article 44
17 February 2024	Digital Services Act applies, including trader traceability (Article 30)	Regulation 2022/2065, Article 93
18 August 2024	Batteries Regulation conformity assessment (Article 17) applies	Regulation 2023/1542, Article 96
1 October 2024	Great Britain: CE recognition no longer expires for most regimes; Fast-Track UKCA	SI 2024/696
13 December 2024	General Product Safety Regulation applies	Regulation 2023/988
1 August 2025	RED Article 3(3)(d), (e) and (f) apply to the categories in Delegated Regulation 2022/30	Delegated Regulation 2022/30
16 February 2026	UK consultation on indefinite recognition of CE-marked medical devices opens	gov.uk
11 September 2026	Cyber Resilience Act reporting obligations apply	Regulation 2024/2847, Article 71
20 January 2027	Machinery Regulation applies; Directive 2006/42/EC repealed	Regulation 2023/1230, as corrected (OJ L 169, 4.7.2023)
11 December 2027	Cyber Resilience Act applies in full; Delegated Regulation 2022/30 repealed	Regulation 2024/2847, Article 71
30 June 2028	End of Great Britain acceptance of CE medical devices under the MDD and AIMDD	MHRA
30 June 2030	End of Great Britain acceptance of CE devices under the IVDD, EU MDR and EU IVDR	MHRA

Claims the texts contradict

Claim (including on earlier versions of this page)	What the texts say
"The importer cannot affix the CE marking" as the whole of its role	The importer must ensure the product bears the CE marking, the conformity assessment was done and the documents are there (RED Article 12(2)); selling under its own name makes it the manufacturer (Article 14)
"ATEX always needs a notified body"	Category 3 equipment is internal production control only (Directive 2014/34/EU, Article 13)
"CE marking costs €10,000 to €30,000, double with a notified body"	No text sets a price; the figures had no source
"Lab lead times are 4 to 8 weeks in Europe"	No text sets lead times; the figure had no source
"No since 2021: you need an authorised representative to sell online"	Article 4 of Regulation 2019/1020 accepts an EU manufacturer, an importer, an authorised representative or, failing these, a fulfilment service provider
"Very large platforms must verify the economic operator under the DSA"	DSA Article 30 requires trader identity details and a self-certification on all platforms allowing distance contracts, except micro and small enterprises not designated as very large
"Every manual must be translated into all official languages of the target Member States"	The language is "as determined by the Member State concerned" (RED Article 10(8))
"A manual in English only is a systematic ground for recall in France"	No text makes this a recall ground; French law requires French in instructions for use (Law 94-665, Article 2)
"Several dedicated DoCs, one per directive, are an alternative"	A single declaration for all acts is required; it may be a dossier of individual declarations (RED Article 18(3) and recital 42)
"A replacement battery must conform to EN 62133"	Harmonised standards are voluntary; a battery falls under Regulation 2023/1542, whose conformity assessment applies since 18 August 2024
"A CB report does not cover EMC; Annex Z carries the national differences"	EU law does not address the CB Scheme. What counts is whether the report covers the EN edition cited in the OJ
"Class A requires a warning to the end user" as a standard rule	The obligation is in the EMC Directive: a clear indication of the restriction of use (Article 18(2))
"Technical files are often kept 15 to 20 years"	The texts require 10 years after placing on the market of each unit; the longer figure had no source
"China Export is a separate mark used by some manufacturers"	The Commission knew of no such mark and read it as a CE marking with the wrong dimensions and proportions (answer to P-5938/2007)
"Switzerland reintroduced its own requirements for machinery after 2021"	The Blue Guide lists machinery among the MRA sectors; only medical devices are listed as partially covered

See also

• CE scope: which acts provide for CE marking and when a unit is placed on the market.
• CE tests: the cited editions under each directive.
• CE technical file: file contents act by act, the DoC and retention.
• Certification test plan, template and checklist: the TPP that anchors every CE campaign.
• Choosing a Notified Body, NANDO and scope verification: how to confirm an NB's notified scope before engaging it.
• Multi-marking layouts, CE, FCC, UKCA, ANATEL: how to lay out CE with other regional marks on one product.
• CPR (305/2011) and EN 50575 cable reaction-to-fire: an adjacent regulation often confused with CE for cables.
• Product recall and EU Safety Gate response procedure: the corrective action procedure after a defect on a CE product.

Sources & references

1. Regulation (EC) No 765/2008, Article 30 and Annex II (CE marking), EUR-Lex eur-lex.europa.eu/eli/reg/2008/765/oj
2. Decision No 768/2008/EC on a common framework for the marketing of products, EUR-Lex eur-lex.europa.eu/eli/dec/2008/768/oj
3. The Blue Guide on the implementation of EU product rules 2022 (OJ C 247, 29.6.2022), European Commission eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52022XC0629(04)
4. Directive 2014/53/EU (RED), Articles 10 to 14, 18 and 20, Annex V, EUR-Lex eur-lex.europa.eu/eli/dir/2014/53/oj
5. Directive 2014/30/EU (EMC), Articles 7, 15 and 18, EUR-Lex eur-lex.europa.eu/eli/dir/2014/30/oj
6. Directive 2014/35/EU (LVD), Articles 6 and 15, EUR-Lex eur-lex.europa.eu/eli/dir/2014/35/oj
7. Answer given on behalf of the Commission to written question P-5938/2007 (China Export mark), European Parliament www.europarl.europa.eu/doceo/document/P-6-2007-5938-ASW_EN.html
8. Regulation (EU) 2019/1020 on market surveillance, Article 4, EUR-Lex eur-lex.europa.eu/eli/reg/2019/1020/oj
9. Regulation (EU) 2022/2065 (Digital Services Act), Articles 29 to 31, EUR-Lex eur-lex.europa.eu/eli/reg/2022/2065/oj
10. Regulation (EU) 2023/1542 on batteries, Articles 17 to 20, EUR-Lex eur-lex.europa.eu/eli/reg/2023/1542/oj
11. Commission Delegated Regulation (EU) 2022/30 (RED Article 3(3)(d), (e) and (f)), EUR-Lex eur-lex.europa.eu/eli/reg_del/2022/30/oj
12. The Product Safety and Metrology etc. (Amendment) Regulations 2024 (SI 2024/696), legislation.gov.uk www.legislation.gov.uk/uksi/2024/696/contents/made
13. Placing UKCA or CE marked products on the market in Great Britain, GOV.UK www.gov.uk/guidance/placing-ukca-or-ce-marked-products-on-the-market-in-great-britain
14. Placing CE, or CE and UKNI marked products on the market in Northern Ireland, GOV.UK www.gov.uk/guidance/placing-ce-or-ce-and-ukni-marked-products-on-the-market-in-northern-ireland
15. Regulating medical devices in the UK, MHRA www.gov.uk/guidance/regulating-medical-devices-in-the-uk
16. Law No 94-665 of 4 August 1994 on the use of the French language, Article 2, Légifrance www.legifrance.gouv.fr/loda/id/JORFTEXT000000349929