PPE Regulation (EU) 2016/425: what you must do before you sell protective equipment in the EU

The PPE Regulation covers equipment worn or held for protection, and five things are excluded

Regulation (EU) 2016/425 defines PPE as “equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health or safety” (Art. 3, point (1)(a)Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 3Click opens the article on EUR-Lex.). Two more things count as PPE: interchangeable components that are essential to the protective function, and connexion systems that connect the equipment to an external device or an anchorage point, are not designed to be permanently fixed and need no fastening works before use (Art. 3, point (1)(b) and (c)Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 3Click opens the article on EUR-Lex.).

The Commission reads the definition broadly: “Sunglasses, cycling or riding helmets, gardening gloves, shin-guards for footballers, harnesses for mountaineering, are all PPE” (PPE Guidelines, section 2.3, Commission guidance). It reads it narrowly in four places. Equipment that protects someone other than the wearer is not PPE, such as masks to protect hospital patients, and neither are gloves worn to protect food. Equipment that only makes a task easier or more comfortable, such as back belts, cushioned shoes or some exoskeletons, is not PPE, though the Commission says each such product is judged on its own. A stand-alone gas detector or alarm is not PPE until it is built into PPE (section 2.3).

The Regulation does not apply to PPE (Art. 2(2)Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 2, paragraph 2Click opens the article on EUR-Lex.):

• specifically designed for use by the armed forces or in the maintenance of law and order;
• designed for self-defence, except PPE intended for sporting activities, so fencing and martial-arts protection are in;
• designed for private use against atmospheric conditions that are not extreme, or against damp and water during dishwashing;
• for exclusive use on seagoing vessels or aircraft that are subject to the international treaties;
• for head, face or eye protection that is covered by UNECE Regulation No 22 on helmets and visors for drivers and passengers of motorcycles and mopeds.

The weather exclusion is for private use only. The Commission says rainwear and protection against ordinary cold sold for professional use are inside the Regulation, and that natural UV radiation is not an atmospheric condition (PPE Guidelines, section 2.2). Protection against heat for private use, such as oven gloves, was outside the old Directive and is inside this Regulation (recital 10).

PPE worn at work follows two sets of rules. The Regulation sets how the product is made. EU countries keep the right to set requirements on how PPE is used, provided they do not affect its design (Art. 6Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 6Click opens the article on EUR-Lex.). Who must wear which PPE on a job is therefore a different law, and this page covers the product you sell.

Clothing that only looks protective, toy imitations and children’s PPE

Clothing for private use with reflective or fluorescent elements added for design or decoration is not PPE (recital 10). The line is the claim and the appearance. If the manufacturer claims a protective function, or markets the product for use as PPE, the PPE requirements apply. The Commission adds that where the product’s appearance gives the impression of visibility PPE, “the manufacturer may not be able to derogate from his obligations even with a warning stating that the product is not intended for use as PPE” (PPE Guidelines, section 2.2).

Children’s equipment follows the purpose. A child’s cycle helmet is PPE “irrespective of its appearance”; a fancy-dress firefighter’s helmet that promises no protection is a toy under the Toys Directive (PPE Guidelines, section 4.2). For the toy side, see CE marking for toys.

The conformity routes, step by step

All routes start with the same duty. Before anything is placed on the market the manufacturer carries out the applicable procedure of Art. 19Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 19Click opens the article on EUR-Lex., or has it carried out (Art. 8(2)Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 8, paragraph 2Click opens the article on EUR-Lex.). The technical documentation of Annex III holds the description of the PPE and its intended use, the risk assessment, the list of applicable essential requirements, drawings and schemes, the harmonised standards applied, the test reports, how production keeps to the design and a copy of the instructions.

Category I, module A. You draw up the Annex III documentation, take the measures needed so that production matches it, then draw up the EU declaration of conformity and affix the CE marking to each PPE (Annex IV, points 2 to 4). No notified body takes part.

Category II, modules B and C. Under module B you apply to one notified body of your choice, with a written declaration that you have lodged the same application with no other body, the technical documentation and specimens of the production type. The body examines the documentation and a specimen of the complete PPE, and issues an EU type-examination certificate where the type meets the requirements (Annex V, points 3, 4 and 6). Under module C you then make sure each unit matches the examined type, sign the declaration and affix the CE marking (Annex VI).

Category III, module B plus C2 or D. Module B is the same. Then you choose:

• Module C2. Before placing PPE on the market you apply to a single notified body for supervised product checks. The body checks a statistical sample at least once a year, at random intervals it chooses, and the first checks come no more than one year after the certificate was issued. You affix the body’s number under its responsibility (Annex VII, points 3, 4, 5.3 and 6).
• Module D. You run a quality system for production, final inspection and testing that a notified body has approved. The body audits it at least once a year and may visit without notice (Annex VIII, points 2 to 4).

Where a category III product protects against several risks and no single notified body is competent for all of them, the Commission’s reading is that several bodies are involved, each under its own application, and the declaration names all of them and their certificates (PPE Guidelines, section 11.21).

For category III PPE made as a single unit to fit one user, the category II route may be followed (Art. 19Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 19Click opens the article on EUR-Lex., last paragraph). A custom orthopaedic shoe is the Commission’s example (PPE Guidelines, section 5.2). Products sold in series are not that case.

The essential health and safety requirements of Annex II, in plain words

The requirements in Annex II are compulsory. They apply only where the matching risk exists for your PPE, and you identify those risks yourself by a risk assessment, thinking about foreseeable uses as well as the intended one (Annex II, preliminary remarks 1, 2, 4 and 5). They are read against the state of the art at the time of design and manufacture (preliminary remark 3).

What they ask, grouped:

• For all PPE (section 1). Adequate protection against the risks it is meant for. A design that lets the user do the job while protected. No risk of its own: materials, including their decomposition products, must not harm the user, and parts touching the user must be free of rough surfaces and sharp edges. Fit: adjustable or in a range of sizes, as light as possible without losing strength, and compatible where one maker sells PPE to be worn together.
• Instructions (point 1.4). See the section on instructions below.
• Common to several types (section 2). Adjustment systems that do not come undone by themselves; face, eye and respiratory PPE that restricts sight and breathing as little as possible and models for users who need sight correction must work with spectacles or contact lenses; PPE that tears away if it is caught by a moving object; and, where ageing affects performance, the month and year of manufacture or obsolescence marked on the item and its packaging. Markings that relate to health and safety should use harmonised pictograms where possible, and words in a language easily understood where the PPE is made available (points 2.1 to 2.14).
• Specific to a risk (section 3). Impact, falls from a height, vibration, compression, cuts and abrasion, drowning, noise, heat and fire, cold, electric shock, radiation, hazardous substances and biological agents, and diving each have their own requirements. Two have marking duties that sellers meet often. Hearing protection must carry labelling that shows the noise attenuation it gives, on each item, or on the packaging where that is not possible (point 3.5). Filtering eye protection must carry the protection-factor number on each item (point 3.9.1).

Where a harmonised standard covers a requirement, it gives you a way to show you meet it. Where none does, or you do not apply it, you show compliance directly, and for categories II and III the notified body assesses it directly in the type-examination (PPE Guidelines, section 4.1).

Harmonised standards give a presumption of conformity, and one Official Journal list names them

PPE that conforms to harmonised standards whose references are published in the Official Journal is presumed to meet the essential requirements those standards cover (Art. 14Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 14Click opens the article on EUR-Lex.). Using a standard is voluntary. Other standards or technical specifications are allowed, but they do not carry the presumption, and you must show that they cover the requirements (PPE Guidelines, section 4.1).

The list in force on 2 October 2026 is Commission Implementing Decision (EU) 2026/1279 of 12 June 2026 (OJ L, 2026/1279, 16.6.2026), amended by Implementing Decision (EU) 2026/1971 of 3 September 2026 (OJ L, 2026/1971, 4.9.2026). The Commission’s standards page shows the same two decisions. These references, from Annex I of the 2026/1279 Decision and the amendment, match the products sellers meet most:

Three details sit behind the table. EN 397:2025 was published with a restriction. The entry says that where clause 4.2.7.5.2.5 reads “5.13” it shall read “5.13.5”, and that compliance with clause 4.2.7.4 gives a presumption of conformity with essential requirement 3.6.1 (Decision (EU) 2026/1279, recital 9 and Annex I). The earlier versions EN 397:2012+A1:2012, EN 420:2003+A1:2009, EN ISO 12312-1:2013 with its A1:2015 amendment, and EN 17353:2020 stay in the Official Journal until their withdrawal on 16 December 2027 (Decision (EU) 2026/1279, Annex II). Annex I of the Decision lists many more references than these, and it is the list to read for any other PPE.

A supplier’s certificate that names an older version of a standard is not automatically void. The Commission’s view is that removing a superseded reference from the Official Journal does not automatically invalidate existing certificates, and the manufacturer assesses whether the changes in the new version affect the product and records that assessment in the technical documentation (PPE Guidelines, section 14).

An EU type-examination certificate lasts at most five years

For categories II and III the certificate is the core paper. Annex V sets the rules:

• Validity. “The period of validity of a newly issued certificate and, where appropriate, of a renewed certificate shall not exceed five years” (Annex V, point 6.1).
• Content. It names the notified body and its number, the manufacturer, the PPE type number, a statement that the type meets the requirements, the harmonised standards or other specifications applied, the protection class where relevant, the dates of issue and expiry, and any conditions. For category III it states that it may be used only together with module C2 or D (point 6.2).
• Changes. You tell the notified body that holds the documentation of every modification to the approved type that may affect conformity. It needs an addition to the certificate (point 7.2).
• Renewal. You ask for a review when the type changes, when the state of the art changes and, at the latest, before expiry. For an expiry-driven review you apply “at the earliest 12 months and at the latest 6 months prior to the expiry date” (point 7.4). Where neither the type nor the state of the art has changed, a simplified review applies without new tests (point 7.6).
• If the certificate stops being valid. The body withdraws it and you must stop placing the PPE on the market (point 7.7).
• Keeping it. You keep the certificate and its annexes with the technical documentation for 10 years after the PPE is placed on the market (point 9).

Certificates issued under the old PPE Directive 89/686/EEC remained valid only until 21 April 2023 (Art. 47(2)Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 47, paragraph 2Click opens the article on EUR-Lex.). A certificate issued under that Directive stopped being valid on 21 April 2023 at the latest, whatever expiry date it shows.

When a supplier sends you a certificate, read it against five things. It names a notified body for the PPE Regulation. It cites Regulation (EU) 2016/425Regulation (EU) 2016/425, Personal Protective Equipment RegulationThe whole regulationClick opens the law on the EU Publications Office.. The expiry date has not passed. It covers the type number on your product. For category III it says it is to be used with module C2 or D. The Commission also warns about papers that are not certificates at all: “under EU law, voluntary or other additional certificates are not a recognised means to prove compliance. Consequently, they have no value in the case of checks by market surveillance authorities or customs”. Its example is a body notified for machinery that issues certificates for PPE masks; such a body “should not” do so, because only a notified body may issue certificates of compliance, and only in the area for which it is notified (European Commission, PPE). More on the paper that does count is in notified body, and on supplier marks in CE mark vs China export.

The EU declaration of conformity follows Annex IX and goes with the PPE or by web address

The declaration states that fulfilment of the applicable essential requirements has been demonstrated. It follows the model in Annex IX, contains the elements of the module you used, is kept up to date and is translated into the language or languages the EU country of sale requires (Art. 15(1)Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 15, paragraph 1Click opens the article on EUR-Lex., Art. 15(2)Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 15, paragraph 2Click opens the article on EUR-Lex.). By drawing it up the manufacturer takes responsibility for the PPE’s compliance (Art. 15(4)Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 15, paragraph 4Click opens the article on EUR-Lex.). Where other EU laws also require a declaration, one declaration covers all of them and names them with their publication references (Art. 15(3)Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 15, paragraph 3Click opens the article on EUR-Lex.).

Annex IX asks for nine things, in this order: the PPE (product, type, batch or serial number); the manufacturer’s name and address and, where applicable, the authorised representative’s; a statement that it is issued under the manufacturer’s sole responsibility; the object of the declaration, which may include a colour image for traceability; the Union harmonisation legislation it conforms to; the harmonised standards used, with dates, or other specifications; where applicable, the notified body’s name, number and its EU type-examination certificate reference; where applicable, the module C2 or D procedure and the notified body under whose surveillance it runs; and additional information. It ends with place, date, name, function and signature. Numbering the declaration is optional.

For categories II and III the declaration names the notified body, its number and the certificate reference, and for category III the body involved in production control as well (PPE Guidelines, section 4.2).

Where does the declaration go? The Regulation gives the manufacturer two choices: to “either provide the EU declaration of conformity with the PPE or include in the instructions and information set out in point 1.4 of Annex II the internet address at which the EU declaration of conformity can be accessed” (Art. 8(8)Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 8, paragraph 8Click opens the article on EUR-Lex.). The Regulation has no shorter form of declaration. The Commission accepts a direct address or a generic page with a search function, as long as the declaration is easily reachable (PPE Guidelines, section 3.1). The manufacturer keeps the declaration for 10 years (Art. 8(3)Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 8, paragraph 3Click opens the article on EUR-Lex.), an importer keeps a copy for the same period (Art. 10(8)Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 10, paragraph 8Click opens the article on EUR-Lex.), and an authorised representative whose mandate allows it does the same (Art. 9(2)Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 9, paragraph 2Click opens the article on EUR-Lex.). More on the document across laws is in the declaration of conformity.

The instructions, markings and contact details must be on the PPE or in the box

Four duties fall on the manufacturer and, for the importer’s own details and the instructions, on the importer (Art. 8Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 8Click opens the article on EUR-Lex., Art. 10Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 10Click opens the article on EUR-Lex.).

• Identification. A type, batch or serial number, or another element that identifies the PPE. Where size or nature does not allow it, the information goes on the packaging or in a document with the PPE (Art. 8(5)Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 8, paragraph 5Click opens the article on EUR-Lex.).
• Contact. Name, registered trade name or trade mark, and a postal address that is a single point of contact, on the PPE or, where that is not possible, on its packaging or in a document with it. The contact details are in a language easily understood by end-users and market surveillance authorities (Art. 8(6)Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 8, paragraph 6Click opens the article on EUR-Lex.). An importer adds its own the same way (Art. 10(3)Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 10, paragraph 3Click opens the article on EUR-Lex.).
• Instructions. The Annex II point 1.4 instructions, in a language that consumers and other end-users easily understand, “as determined by the Member State concerned”. They must be clear, understandable, intelligible and legible, as must any labelling (Art. 8(7)Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 8, paragraph 7Click opens the article on EUR-Lex.). The Regulation gives no list of languages: each EU country decides. Recital 18 says that in packs of several units the instructions should accompany each smallest commercially available unit, and the Commission reads the duty as one set of instructions for each PPE or each batch of identical products delivered to the same end-user (PPE Guidelines, section 3.1).
• CE marking. Visible, legible and indelible on the PPE. Where that is not possible or not warranted by the nature of the PPE, on the packaging and the documents with it. It goes on before the PPE is placed on the market, and the notified body’s number follows it on category III PPE. A pictogram for the risk may follow (Art. 17Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 17Click opens the article on EUR-Lex.).

What the instructions of Annex II point 1.4 contain, beyond the manufacturer’s name and address: storage, use, cleaning, maintenance, servicing and disinfection; the performance recorded in the technical tests; accessories and spare parts; the classes of protection and limits of use; the month and year or period of obsolescence; suitable transport packaging; what each marking means; the risk the PPE protects against; the reference to the Regulation and other EU laws; the name, address and number of any notified body; the harmonised standards used with their dates; and the web address of the declaration. The last four items need not be in the instructions if the declaration itself accompanies the PPE.

A business outside the EU needs an EU operator, and a private label makes you the manufacturer

The PPE Regulation has four economic operators: manufacturer, authorised representative, importer and distributor (Art. 3, points (4) to (8)Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 3Click opens the article on EUR-Lex.). The manufacturer is whoever makes or has PPE designed or made and markets it under its own name or trademark. An importer or distributor that places PPE on the market under its own name, or changes PPE already on the market in a way that may affect compliance, is treated as the manufacturer and takes on every manufacturer duty (Art. 12Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 12Click opens the article on EUR-Lex.). An importer is established in the EU and places PPE from a third country on the EU market (Art. 3, point (6)Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 3Click opens the article on EUR-Lex.).

On top of that, Regulation (EU) 2019/1020 lists the PPE Regulation among the laws for which a product “may be placed on the market only if there is an economic operator established in the Union who is responsible for the tasks set out in paragraph 3” (Art. 4(1)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 1Click opens the article on EUR-Lex., Art. 4(5)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 5Click opens the article on EUR-Lex.). That operator is any of these: an EU manufacturer; an importer where the manufacturer is outside the EU; an authorised representative with a written mandate; or, only where none of those three is established in the EU, a fulfilment service provider established in the EU for the products it handles (Art. 4(2)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 2Click opens the article on EUR-Lex.). Its tasks are to verify that the declaration and technical documentation exist, keep the declaration available, hand the authorities what they ask for in a language they easily understand, tell them where it believes the product presents a risk, and cooperate on corrective action (Art. 4(3)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 3Click opens the article on EUR-Lex.). Its name and contact details go on the product, its packaging, the parcel or an accompanying document (Art. 4(4)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 4Click opens the article on EUR-Lex.). The rule has applied since 16 July 2021 (Art. 44Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 44Click opens the article on EUR-Lex.).

An online offer counts as made available in the EU when it is targeted at end users in the EU, which is the case where you direct your activities to an EU country by any means (Art. 6Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 6Click opens the article on EUR-Lex.). A shop outside the EU that directs its offer at EU buyers is therefore making PPE available on the EU market in the sense of the Regulation.

Two limits apply to an authorised representative under this Regulation. The manufacturer cannot hand over the duty to design and make the PPE to the essential requirements, nor the duty to draw up the technical documentation (Art. 9(1)Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 9, paragraph 1Click opens the article on EUR-Lex.). The mandate must allow at least three things: keeping the declaration and documentation for the authorities for 10 years, giving the authorities the information they ask for and cooperating on risks (Art. 9(2)Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 9, paragraph 2Click opens the article on EUR-Lex.). The annexes allow the representative to sign the declaration and affix the CE marking if the mandate says so (Annex IV, point 5; Annex VI, point 4). For a manufacturer outside the EU the Commission puts the duty to keep the declaration with the importer or the authorised representative (PPE Guidelines, section 4.2). More on the roles and on the representative the marketplaces ask for is in EU responsible person.

On a marketplace listing, the General Product Safety Regulation adds one rule for PPE that is a consumer product, meaning it is intended for consumers or likely to be used by them (Art. 3(1)Regulation (EU) 2023/988, General Product Safety RegulationArticle 3, point 1Click opens the article on EUR-Lex.). Its rule on the duties of economic operators does not apply to products covered by EU harmonisation legislation, but its rule for distance sales does. The online offer must show the manufacturer’s name and its postal and electronic address, the EU operator of Art. 4(1)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 1Click opens the article on EUR-Lex. where the manufacturer is outside the EU, a picture and the type of the product, and any warning or safety information in a language consumers easily understand (Art. 2(1)Regulation (EU) 2023/988, General Product Safety RegulationArticle 2, paragraph 1Click opens the article on EUR-Lex., Art. 19Regulation (EU) 2023/988, General Product Safety RegulationArticle 19Click opens the article on EUR-Lex.). What each marketplace asks for in its forms is in GPSR marketplace requirements.

Great Britain accepts CE marking and has its own version of the PPE Regulation

The UK government’s table of rules under which a manufacturer can self-declare conformity for the UKCA marking names the Personal Protective Equipment Regulations, “Regulation (EU) 2016/425Regulation (EU) 2016/425, Personal Protective Equipment RegulationThe whole regulationClick opens the law on the EU Publications Office. as brought into UK law and amended”, for category I PPE. GB also keeps recognising the CE marking, alongside or in place of the UKCA marking, under The Product Safety and Metrology (Amendment) Regulations 2024 (UK government, updated 21 August 2026). The UK version of the text is published at legislation.gov.uk, up to date with changes in force on or before 2 October 2026.

A GB importer must be established in the UK. The government’s guidance lists among an importer’s duties to indicate its name, trade name or trademark and postal address on the product. For goods imported from an EEA state, or in some cases Switzerland, before 31 December 2027, the importer’s details can instead go on the packaging or an accompanying document.

Northern Ireland follows the EU. Under the Windsor Framework the relevant EU rules for manufactured products apply there, and products carry the CE marking, or the CE and UKNI markings (UK government, updated 8 April 2026). The UK text is a separate instrument from the EU text: legislation.gov.uk publishes the UK version and the EU publishes its own.

What happens if you sell PPE without the route, the marking or the papers

An EU country that finds any of these must require the operator to put an end to the non-compliance: the CE marking is missing or wrongly affixed; the notified body’s number is missing or wrongly affixed on category III PPE; the declaration is not drawn up or not drawn up correctly; the technical documentation is missing or incomplete; or the manufacturer’s or importer’s name and address are absent, false or incomplete. If the non-compliance continues it restricts or prohibits the PPE, or has it recalled or withdrawn (Art. 41Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 41Click opens the article on EUR-Lex.).

Where the authorities have sufficient reason to believe PPE presents a risk, they evaluate it against the whole Regulation and, if it does not comply, require corrective action, withdrawal or recall within a reasonable period. The operator must make that action reach all the PPE it supplied across the Union (Art. 38Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 38Click opens the article on EUR-Lex.). Art. 37Regulation (EU) 2016/425, Personal Protective Equipment RegulationThe whole regulationClick opens the law on the EU Publications Office. refers to Regulation (EC) No 765/2008Regulation (EC) No 765/2008, accreditation and market surveillance (CE marking)The whole regulationClick opens the law on the EU Publications Office. for the general market surveillance and import controls; since 16 July 2021 those controls are in Regulation (EU) 2019/1020Regulation (EU) 2019/1020, Market Surveillance RegulationThe whole regulationClick opens the law on the EU Publications Office., which deleted Chapter III of the 2008 Regulation (Art. 37Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 37Click opens the article on EUR-Lex., Art. 44Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 44Click opens the article on EUR-Lex.). Compliant PPE that still presents a risk is dealt with separately (Art. 40Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 40Click opens the article on EUR-Lex.). Each EU country sets its own penalties, which may include criminal penalties for serious infringements and must be effective, proportionate and dissuasive (Art. 45Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 45Click opens the article on EUR-Lex.).

What the law leaves open

• Price and time of a notified body. The Regulation sets no fee scale and no timetable. It says only that the cost of a simplified renewal must be proportionate to the administrative burden (Annex V, point 7.6). No official source consulted for this page gives a price.
• Language. Instructions are in the language the EU country decides (Art. 8(7)Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 8, paragraph 7Click opens the article on EUR-Lex.). The Regulation lists none.
• Borderline products. The Commission judges products such as exoskeletons, back belts and cushioned shoes case by case (PPE Guidelines, section 2.3).
• Emergency procedures. Regulation (EU) 2024/2748 added Articles 41a to 41e. They apply only if the Commission has adopted an implementing act for PPE designated as crisis-relevant goods, and only during an internal market emergency mode. Among other things they ask notified bodies to process applications for that PPE as a matter of priority (consolidated text of 29 May 2026).
• Changes to categories. The Commission may move a risk from one category to another by delegated act (Art. 42Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 42Click opens the article on EUR-Lex.). The Annexes of the consolidated text of 29 May 2026 read the same as the 2016 text, so none has been moved.
• Old name. People still say “PPE directive”. Directive 89/686/EEC was repealed with effect from 21 April 2018 (Art. 46Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 46Click opens the article on EUR-Lex.). Products that complied with it and were placed on the market before 21 April 2019 could still be sold (Art. 47(1)Regulation (EU) 2016/425, Personal Protective Equipment RegulationArticle 47, paragraph 1Click opens the article on EUR-Lex.).

What you can skip