Distributes a software product, in Malta

Consumer Affairs Act (Cap. 378), Part IX · Read the law's page

• Do not assume Part IX answers whether standalone software is a product: article 56 defines a product as any movable and includes electricity, gas and primary agricultural products, and it is not settled whether that reaches software supplied on its own (Art. 56).
• If you manufacture a finished or processed product, a component part or a raw material, or put your name, trade mark or other distinguishing feature on a product as if you made it, you answer for damage a defect in it causes (Arts. 56 and 57).
• If you import into an EEA State a product made outside a Member State, you answer as its producer (Art. 56).
• If you supply a product and the producer cannot be identified, give the injured party the identity and full address of the producer, or of the person who supplied you, within thirty days of a written request, or you are treated as the producer, and be ready to prove that you did so (Art. 59).
• Offer the safety a person is entitled to expect, judged on all circumstances including how the product is presented and marketed, the directions and warnings you provide, the use it could reasonably be expected to be put to, and the time you put it into circulation (Art. 60(1)).
• Judge your product against the safety usually provided by other models of the same type, because it is defective if it falls short, and a better product coming later does not by itself make yours defective (Art. 60(2) and (3)).
• Be ready to prove one of the defenses if you want to be excused: that you did not put the product into circulation, that the defect probably did not exist then or arose afterwards, that it was not made for an economic purpose or in the course of your business, that the defect is due to compliance with a mandatory legal or public authority requirement, or that the state of scientific and technical knowledge when you put it into circulation could not reveal the defect, because the injured party only has to prove the damage, the defect and the causal link and not your fault (Arts. 58 and 62).
• If you make a component or a raw material, be ready to prove that the defect is attributable to the design of the product it was fitted into or to the instruction of that product's manufacturer (Art. 62(f)).
• Keep records showing when you put the product into circulation, because you carry the burden of proving that date (Art. 67(4)).
• Be ready to pay or deposit a referee's fees provisionally if a court orders it on prima facie evidence that a defect in the product caused the damage (Art. 63).
• Do not rely on a contract term, a notice or any other means to limit or exclude your liability (Art. 68).
• Answer jointly and severally with every other person liable for the same damage, and do not count on a third party's act or omission to reduce your liability (Arts. 64 and 66).

S.L. 627.03, regs. 10, 11, 12 (L.N. 214 of 2022), Accessibility Measures (European Accessibility Act) Regulations · Read the law's page

• If you are a distributor, act with due care in relation to the requirements of the Regulations when you make a product available on the market (reg. 10(1)).
• Before making a product available, verify that it bears the CE marking, comes with the required documents and with instructions and safety information in a language consumers and end-users in the Member State where it is made available can easily understand, and that the manufacturer and importer have complied with regulations 7(5), 7(6) and 9(4) (reg. 10(2)); the EU declaration of conformity states which requirements are subject to regulation 14 where the manufacturer used it (reg. 16(1)).
• If you consider or have reason to believe a product does not conform to the applicable accessibility requirements, do not make it available until it does, and tell the manufacturer or importer and the market surveillance authority (reg. 10(3)).
• While a product is under your responsibility, keep storage or transport conditions from jeopardising its compliance with the applicable accessibility requirements (reg. 10(4)).
• If you have reason to believe a product you made available does not conform, make sure the corrective measures needed, or withdrawal, are taken, and immediately tell the competent national authorities of the Member States where you made it available, with details of the non-compliance and any corrective measures (reg. 10(5)).
• On a reasoned request from a competent national authority, give it the information and documentation needed to show the product conforms and cooperate on action to eliminate the non-compliance (reg. 10(6)).
• If you, as the distributor, rely on the fundamental alteration or disproportionate burden ground in regulation 14(1) for a product, carry out the assessment against the criteria in Annex VI, document it, keep the results for five years from the last making available of the product on the market, give the authority a copy on request, and send the market surveillance authority information that you rely on it; regulation 14 binds every economic operator, which regulation 2 defines to include the importer and the distributor (regs. 2, 14(2), 14(3) and 14(7)).
• If you place a product on the market under your own name or trade mark, or modify a product already on the market so that compliance may be affected, meet the manufacturer's obligations under regulation 7 (reg. 11).
• On request, identify to the market surveillance authority or a competent national authority the operators that supplied you with a product and those you supplied, and be able to do so for five years after the supply in each direction (reg. 12).

S.L. 627.03, regs. 19-23, 26, 27, with Cap. 413, arts. 22, 32-32F (L.N. 214 of 2022), Accessibility Measures (European Accessibility Act) Regulations · Read the law's page

• If you are an economic operator, cooperate fully with the market surveillance authority's evaluation of a product, and where it requires corrective action bring the product into compliance within the reasonable period it sets, withdrawing the product if you fail to take adequate corrective action in that period (reg. 20(1)).
• Ensure that all appropriate corrective action is taken in respect of all the products concerned that you have made available on the market throughout the Union (reg. 20(3)).
• Where the market surveillance authority finds a formal non-compliance (CE marking missing or wrongly affixed, EU declaration of conformity not drawn up or not drawn up correctly, technical documentation not available or not complete, identification details absent, false or incomplete, or another administrative requirement of regulation 7 or 9 not met), put an end to it (reg. 22(1)).
• If you relied on regulation 14, give the market surveillance authority or the authority responsible for checking compliance of services the assessment and its results on request, so that it can check that the assessment was conducted, review the use of the Annex VI criteria and check compliance with the applicable accessibility requirements (regs. 14(3), 19(2) and 23(1)(a)).
• Permit the Commission for the Rights of Persons with Disability to enter premises, public or private, for investigations, inspections or surveys, and comply with a decision of its Investigations Unit or an order of its Enforcement Unit to cease an act or omission in breach (Equal Opportunities (Persons with Disability) Act, arts. 32(4) and 32(5)).

S.L. 627.03, regs. 3(1), 4(1)-(2), 7, 8, 12, 14-18 (L.N. 214 of 2022), Accessibility Measures (European Accessibility Act) Regulations · Read the law's page

• If you are a manufacturer, place a product listed in regulation 3(1) on the market only if it complies with the accessibility requirements of Section I of Annex I and, unless it is a self-service terminal, Section II of Annex I, subject to regulation 14 (regs. 3(1), 4(1) and 4(2)); this implements Article 4 of Directive (EU) 2019/882.
• Design and manufacture the product in accordance with the applicable accessibility requirements (reg. 7(1)): provide information on the product and instructions for use through more than one sensory channel, in an understandable and perceivable way, in fonts of adequate size and suitable shape with sufficient contrast; give the user interface alternatives to vision, hearing, speech and touch, flexible magnification, brightness and contrast, an alternative to colour and to audible signals, user control of volume and speed, alternatives to fine motor control and to biometric identification, enough time for interaction, protection of privacy when accessibility features are used, no triggering of photosensitive seizures, and software and hardware for interfacing with assistive technologies (Annex I, Section I, points 1 and 2).
• Meet the sector-specific product requirements (Annex I, Section I, point 2(o)): self-service terminals provide text-to-speech technology, allow personal headsets, alert the user through more than one sensory channel where a timed response is required, allow the time given to be extended and do not require an accessibility feature to be activated before a user who needs it can turn it on; e-readers provide text-to-speech technology; consumer terminal equipment used for electronic communications services handles real time text and high fidelity audio where it has text capability, handles total conversation where it has video capability, couples effectively to hearing technologies and avoids interference with assistive devices; and consumer terminal equipment used for accessing audiovisual media services makes available to persons with disabilities the accessibility components provided by the audiovisual media service provider.
• Where support services (help desks, call centres, technical support, relay services and training services) are available, make them provide information on the accessibility of the product and its compatibility with assistive technologies, in accessible modes of communication (Annex I, Section I, point 3).
• For products other than self-service terminals, make the packaging and the information in it accessible, and make instructions for installation, maintenance, storage and disposal that are not on the product publicly available, in accessible forms, when the product is placed on the market (Annex I, Section II).
• Where Sections I to VI of Annex I do not address a function of the product, make that function accessible by meeting the functional performance criteria of Section VII, which include at least one mode of operation that does not require vision, hearing, vocal input, perception of colour or fine motor control (Annex I, Section VII).
• Draw up the technical documentation under Annex IV, carry out the conformity assessment procedure in that Annex or have it carried out, and, where compliance is demonstrated, draw up an EU declaration of conformity and affix the CE marking (reg. 7(2); Annex IV).
• Keep the technical documentation and the EU declaration of conformity for five years after the product has been placed on the market, and keep procedures in place so that series production stays in conformity, taking changes in product design or characteristics and in harmonised standards or technical specifications into account (regs. 7(3) and 7(4)).
• Put a type, batch or serial number on the product, indicate your name, registered trade name or trade mark and a single contact address on the product, its packaging or an accompanying document in a language end-users and competent national authorities easily understand, and supply instructions and safety information, clear and intelligible, in a language consumers and end-users can easily understand as the market surveillance authority determines from time to time (regs. 7(5), 7(6) and 7(7)).
• If you have reason to believe a product you placed on the market does not conform, immediately take the corrective measures needed or withdraw it, inform the competent national authorities of the Member States where you made it available with details of the non-compliance and the corrective measures, and keep a register of non-complying products and related complaints (reg. 7(8)).
• On a reasoned request from a competent national authority, give it all the information and documentation needed to show the product conforms, in a language it can easily understand, and cooperate on any action to eliminate the non-compliance (reg. 7(9)).
• Make the EU declaration of conformity state that fulfilment of the applicable accessibility requirements has been demonstrated and, where you used regulation 14, which requirements are subject to that exception; give it the model structure in Annex III to Decision No 768/2008/EC and the elements in Annex IV, keep it updated, translate it into the language or languages the Member State requires, and use a single declaration where several instruments require one (regs. 16(1) to 16(3)).
• Affix the CE marking visibly, legibly and indelibly to the product or its data plate (or to the packaging and accompanying documents where that is not possible) before placing the product on the market, and observe the relevant provisions of Regulation (EC) No 765/2008 and of the Market Surveillance and CE Marking Regulations (regs. 17 and 18).
• If you appoint an authorised representative, do so by written mandate that allows it at least to keep the EU declaration of conformity and technical documentation at the authorities' disposal for five years, supply the information and documentation needed to show conformity and cooperate on action to eliminate non-compliance; the obligations in regulation 7(1) and the drawing up of the technical documentation cannot be part of the mandate (reg. 8).
• On request, identify to the market surveillance authority or a competent national authority any operator that supplied you with a product and any operator you supplied, and be able to do so for five years after the supply in each direction (reg. 12).
• If you rely on the fundamental alteration or disproportionate burden ground in regulation 14(1), carry out an assessment against the criteria in Annex VI, document it, keep the results for five years from the last making available of the product on the market and give the authority a copy on request (regs. 14(2) and 14(3)); a microenterprise dealing with products need not document the assessment but must give the authority the relevant facts on request (reg. 14(4)).
• Do not rely on the disproportionate burden ground where you receive funding from other sources than your own resources for the purpose of improving accessibility, and send the market surveillance authority or the relevant competent authority information that you rely on regulation 14(1) for a specific product (regs. 14(6) and 14(7)); regulation 14(7) ends with the proviso that sub-regulation (1) shall not apply to microenterprises, while Article 14(8) of Directive (EU) 2019/882 exempts microenterprises only from sending that information.

S.L. 627.03, regs. 9, 11, 12 (L.N. 214 of 2022), Accessibility Measures (European Accessibility Act) Regulations · Read the law's page

• If you are an importer, place only compliant products on the market (reg. 9(1)).
• Before placing a product on the market, make sure the manufacturer has carried out the conformity assessment procedure in Annex IV, has drawn up the technical documentation that Annex requires, has put the CE marking on the product and the required documents with it, and has met the identification and address requirements of regulations 7(5) and 7(6) (reg. 9(2)); the EU declaration of conformity you check states which requirements are subject to regulation 14 where the manufacturer used it (reg. 16(1)).
• If you consider or have reason to believe a product does not conform to the applicable accessibility requirements, do not place it on the market until it does, and tell the manufacturer and the market surveillance authority (reg. 9(3)).
• Indicate your name, registered trade name or trade mark and a contact address on the product, its packaging or an accompanying document, in a language end-users and competent national authorities easily understand, and make sure the product comes with instructions and safety information in a language consumers and end-users can easily understand as the market surveillance authority determines from time to time (regs. 9(4) and 9(5)).
• While a product is under your responsibility, keep storage or transport conditions from jeopardising its compliance with the applicable accessibility requirements (reg. 9(6)).
• Keep a copy of the EU declaration of conformity at the disposal of the market surveillance authority and other competent national authorities for five years and make sure the technical documentation can be produced on request (reg. 9(7)).
• If you have reason to believe a product you placed on the market does not conform, immediately take the corrective measures needed or withdraw it, tell the competent national authorities of the Member States where you made it available, with details, and keep a register of non-complying products and related complaints (reg. 9(8)).
• On a reasoned request from a competent national authority, give it the information and documentation needed to show the product conforms, in a language it can easily understand, and cooperate on action to eliminate the non-compliance (reg. 9(9)).
• If you, as the importer, rely on the fundamental alteration or disproportionate burden ground in regulation 14(1) for a product, carry out the assessment against the criteria in Annex VI, document it, keep the results for five years from the last making available of the product on the market, give the authority a copy on request, and send the market surveillance authority information that you rely on it; regulation 14 binds every economic operator, which regulation 2 defines to include the importer and the distributor (regs. 2, 14(2), 14(3) and 14(7)).
• If you place a product on the market under your own name or trade mark, or modify a product already on the market so that compliance may be affected, meet the manufacturer's obligations under regulation 7 (reg. 11).
• On request, identify to the market surveillance authority or a competent national authority the operators that supplied you with a product and those you supplied, and be able to do so for five years after the supply in each direction (reg. 12).

S.L. 591.6, Cyber Resilience Regulations, made under Chapter 591 (Malta Digital Innovation Authority Act) · Read the law's page

• This designation does not itself add a duty beyond the Cyber Resilience Act's own: the Regulation's essential requirements and market-placement duties reach a manufacturer's product with digital elements from 11 December 2027, and its vulnerability and incident reporting duties have applied since 11 September 2026, both documented at the European Union jurisdiction level.
• Report an actively exploited vulnerability or a severe incident to ENISA's single reporting platform under the Regulation's own Article 14 and Article 16; from 11 December 2027, regulation 10 of the Cyber Resilience Regulations, 2026 designates the national CSIRT as the CSIRT designated as coordinator for Regulation (EU) 2024/2847, which article 8(1) of the Measures for a High Common Level of Cybersecurity across the European Union (Malta) Order establishes within the Malta Information Technology Agency.