Machinery Directive Consulting
It applies to manufacturers, authorized representatives, and importers who place machinery, partly completed machinery, interchangeable equipment, and lifting accessories on the European market. The regulation covers almost all industrial machinery and plants, including cases of those who internally assemble a production line, build a machine for own use, or carry out substantial modifications to existing plants. In these cases, the user assumes the same obligations as the manufacturer, including CE marking.
The following are required: a technical construction file, risk analysis according to EN ISO 12100, instructions for use in the user’s language, a CE declaration of conformity, and physical CE marking on the product.
Yes, it is fully valid. It will be replaced by the Machinery Regulation (EU) 2023/1230 starting from January 20, 2027. MTM Consulting also supports companies in the transition toward the new regulation.
It depends on the complexity of the product. For standard machines, it ranges from 4 to 8 weeks; for complex machines, it can take 12-16 weeks. MTM provides a detailed work plan after the initial free analysis.
ATEX Directive Consulting
Directive 2014/34/EU concerns products placed on the market. Legislative Decree 81/2008 (Title XI) concerns workplaces with explosion risks. MTM integrates both compliances into a single consultancy path.
The intervention of a notified body is mandatory for Category 1 (Group II) and M1 (Group I) equipment. For Category 2, the obligation varies based on the nature of the product (electrical or non-electrical). For Category 3, the intervention of a notified body is never required, and the manufacturer can proceed independently with internal documentation.
Yes. It must be reviewed whenever production processes, materials, or plant layouts change, or following structural modifications. MTM offers periodic review services.
Plants must comply with the safety requirements of the Legislative Decree. 81/2008. New equipment must be ATEX certified. MTM assesses the level of compliance and indicates priority corrective actions.
Machinery Regulation
Regulation (EU) 2023/1230 will become mandatory from January 20, 2027, the date on which the previous Directive 2006/42/EC will be definitively repealed. Until that deadline, companies must continue to apply exclusively Directive 2006/42/EC. Currently, in fact, early voluntary application of the new Regulation for CE marking is not permitted. However, it is essential to use this transition period to adapt design and technical documentation to the new requirements. The goal is to be ready for January 20, 2027, when the transition to the new legislation will be immediate and without derogations.
No. Products already placed on the market before January 20, 2027 in compliance with Directive 2006/42/EC remain valid and do not require new interventions. However, all new machines placed on the market starting from January 20, 2027, must mandatory comply with Regulation (EU) 2023/1230. MTM analyzes each situation case by case to guide its clients through the correct regulatory transition to maintain the CE compliance of your machines.
Yes. The regulation introduces specific provisions for systems with machine learning that perform safety functions, requiring updated risk assessments and dedicated documentation.
It is a comparative analysis between existing documentation (Directive 2006/42/EC) and the new requirements of Regulation 2023/1230. It identifies what is missing, what needs to be updated, and the intervention priorities.
PED Directive
Yes. It applies both to individual equipment and to assemblies, i.e., groups of pressure equipment assembled to form an integrated functional unit.
The directive applies to equipment with a maximum allowable pressure (PS) greater than 0.5 bar.
For category II, III, and IV equipment, the involvement of a notified body is mandatory. For category I, the manufacturer can proceed independently.
Yes. Any pressure equipment falling within the application limits of the PED directive placed on the EU market must comply with Directive 2014/68/EU, regardless of the country of production.
Machine Safety "Pre-1996"
No. If placed on the market before September 21, 1996, they are not subject to the Machinery Directive. However, they must comply with the minimum safety requirements of Annex V of the Legislative Decree. 81/2008.
The employer is directly responsible. They must ensure that all machines in use are safe and comply with current legislation, regardless of the year of construction.
The machine cannot be used. The company risks administrative sanctions, production halts, and, in the event of an accident, civil and criminal liability for the employer.
Internal overhauling is not sufficient without a formal risk assessment and the preparation of the technical documentation required by Annex V. MTM Consulting verifies compliance and prepares all necessary documentation.
CE Marking HelpDesk
Queries are unlimited for the entire duration of the subscription. There are no volume constraints: you can send one question or a hundred, the cost remains the same.
A response is guaranteed within 48 working hours from an MTM senior technician. For specific emergencies, it is possible to agree on specific priorities.
Yes. The service covers both the Machinery Directive 2006/42/EC and the new Regulation (EU) 2023/1230, including all questions regarding the transition and the application of the new rules.
Yes. It is possible to activate multiple accounts for different users. When contacting MTM, please indicate the number of accounts you wish to activate to receive the correct quote.
Inspection of Newly Acquired Machinery
Before commissioning, ideally immediately after delivery. In this way, non-compliances can be identified before the machine is used, avoiding risks to workers and possible disputes with the supplier.
Yes. CE marking is a presumption of compliance defined by the manufacturer. However, it is not an absolute guarantee of the absence of safety risks in every condition of use. It is the employer’s responsibility to ensure that the machine actually complies with essential safety requirements before making it available to workers and that it meets essential requirements in the specific context of use.
MTM provides a technical report with the identified criticalities and proposes concrete solutions for adaptation. If the machine has not yet been formally accepted, the report also supports any disputes with the supplier.
Yes. MTM Consulting operates throughout the Italian territory. Consultancy is also available remotely for an initial documentary analysis, followed by an on-site inspection when necessary.
CE Marking for Medical Devices
The manufacturer of the medical device is responsible for the CE marking and must ensure that the device meets all the requirements of Regulation (EU) 2017/745 before placing it on the market.
No. Class I devices can be self-certified. For classes IIa, IIb, and III, the involvement of a notified body accredited under Regulation (EU) 2017/745 is mandatory.
Regulation (EU) 2017/745 introduces more stringent requirements for clinical evaluation, post-market surveillance, and traceability (UDI code). All devices already certified under the old directive must be re-certified according to the new regulation.
The UDI (Unique Device Identifier) is a unique code mandatory for all medical devices placed on the EU market. It allows for the traceability of the device throughout the entire supply chain and must be registered in the European database EUDAMED.
ErP Directive Consulting
They apply to all energy-related products that consume, produce, or transfer energy, or that have an indirect impact on energy use. This includes motors, pumps, fans, lighting products, heating appliances, and many others.
Each product category has one or more specific implementing Regulations. MTM Consulting identifies the applicable regulation, analyzes the requirements in force, and supports the client in adaptation. Legislation is updated frequently: it is essential to verify the current version.
Yes. Products subject to the ErP Directive and ESPR Regulation must bear the CE marking, which also includes compliance with the eco-design requirements of the applicable Regulation. The CE declaration of conformity must explicitly mention the ErP Directive or the ESPR regulation.
The product can be withdrawn from the market by surveillance authorities. The manufacturer or importer risks significant administrative sanctions. In some countries, ErP requirements are verified through random market checks.
Construction Products Regulation
All products manufactured to be permanently incorporated into construction works fall under this: steel or concrete structures, waterproofing systems, fire doors, piping, insulation materials, electrical cables for building use, and many others.
required by the CPR?
It is the document by which the manufacturer declares the performance of the product in relation to its essential characteristics defined by the harmonized EN standard. It is not a declaration of conformity but a declaration of measured or calculated performances.
It depends on the AVCP (Assessment and Verification of Constancy of Performance) system assigned to the product by the harmonized standard. For systems 1, 1+, and 2+, the involvement of a notified body is required. For systems 3 and 3+ (recently introduced), tests at accredited laboratories are sufficient, while for system 4, the manufacturer can proceed independently.
No. The CPR CE marking indicates that the product’s performance has been declared according to the harmonized standard. It does not certify minimum performance. It is the designer of the work who must select products with performance suitable for the specific application.
UKCA Marking
The definitive obligation never came into effect. The transition was initiated on January 1, 2021, providing for a transition period that was extended several times until 2024.
In May 2024, the British Government then decided to recognize CE marking indefinitely for many product categories, including machinery. CE machines are therefore accepted, and the use of UKCA remains an optional choice for manufacturers.
In many cases, yes. The Protocol/Agreement on Northern Ireland provides that CE marking is accepted for various products. The regulatory situation is constantly evolving: MTM verifies applicability on a case-by-case basis.
In part. CE technical documentation is a good starting point, but it must be adapted to UKCA requirements: UK reference standards, UKCA Declaration of Conformity and, if required, involvement of UK Approved Bodies instead of European notified bodies.
Manufacturers established outside the UK market who place products on the GB market must designate a Responsible Person established in the UK territory. MTM can support in identifying the necessary responsible figures.
Non-EU Import of Machinery
The European importer. They do not assume the role of manufacturer unless they market the machine under their own brand or make substantial modifications to it, but they remain the party responsible for verifying safety requirements and the presence of the CE marking.
The importer therefore has the obligation to verify that the non-EU manufacturer has prepared a correct and complete technical file, and to make it available to any control bodies that request it.
Not automatically. CE marking must result from a correct conformity assessment process. MTM Consulting verifies the documentation to ascertain whether the process was carried out correctly or if it is necessary to supplement or redo the documentation.
It is necessary to request the documentation from the supplier. If it is unavailable or incomplete, the importer must have a new technical file drawn up. MTM Consulting manages this process, including risk assessment and verification of EHSRs.
Yes, but with its own specificities. Partly completed machinery does not receive CE marking but must be accompanied by assembly instructions and a declaration of incorporation. The importer is responsible for the correctness of these documents under the Machinery Directive.
UNI EN ISO 9001:2015
Any company or entity, regardless of sector or size. The standard is designed to be flexible and adaptable to every type of organization, from small manufacturing firms to large service companies.
No, it is not mandatory by law. However, it is often requested by clients, in public and private tenders, or to access regulated markets. In many industrial sectors, it is considered a minimum requirement to qualify as a supplier.
The certification is valid for three years, but it must be maintained through annual surveillance audits conducted by the certification body. At the end of the three-year period, a renewal audit is performed.
It depends on the complexity of the organization and the starting level. On average, a complete certification project takes 3 to 6 months. MTM Consulting defines a personalized work plan after an initial analysis of the company situation.
UNI EN ISO 14001:2015
It is a structured set of practices and procedures that allows an organization to monitor, control, and improve its environmental performance, in compliance with current regulations and the objectives of its environmental policy.
No, it is voluntary. However, it is strongly recommended for companies that want to demonstrate a concrete commitment to sustainability, access public tenders and international markets, or qualify as suppliers for large companies with structured ESG policies.
It depends on the company’s complexity and the starting level. On average, the process takes 3 to 6 months. MTM Consulting builds a personalized work plan after an initial analysis of the company’s environmental situation.
All sectors: manufacturing, construction, services, healthcare, transport, energy. The standard is designed to be flexible and adaptable to any organizational reality, regardless of size or type of activity.
UNI EN ISO 45001:2023
No, it is a voluntary standard. However, it helps companies comply in a structured and verifiable way with the obligations provided for by the Legislative Decree. 81/2008. In many cases, it is required to participate in public tenders, contracts, or to qualify as suppliers for large companies.
ISO 45001:2023 has replaced OHSAS 18001 and its previous 2018 version, introducing a structure aligned with ISO 9001 and ISO 14001 (High Level Structure), greater attention to the organizational context, worker participation, and a proactive approach to risk prevention.
Yes. The three standards share the same high-level structure (Annex SL), which makes them easily integrable into an integrated Quality-Environment-Safety management system. MTM Consulting designs integrated paths that optimize certification times and costs.
It depends on the complexity of the organization and the starting point. On average, the process takes 3 to 6 months. MTM Consulting defines a tailored work plan after an initial analysis of the company situation. Write to [email protected] for an initial contact without obligation.
Life Cycle Assessment
The LCA study is governed by the ISO 14040 standard, which defines principles and general structure, and by ISO 14044, which specifies technical and methodological requirements. If the study is aimed at an Environmental Product Declaration (in order to obtain an EPD), specific Product Category Rules (PCR) for the product category also apply.
The LCA study evaluates all environmental impacts associated with a product’s life cycle: resource consumption, polluting emissions, land use, water consumption, and others. The carbon footprint is limited to quantifying greenhouse gas emissions. The carbon footprint is therefore a more focused version of the LCA, covering only one aspect of the overall environmental impact.
No. Even if the products belong to the same category, each LCA is contextual and depends on real data: supply chain, procurement, production processes, use, and disposal. The analysis must be carried out or adapted for each product or in the event of significant changes to the processes.
Yes. It is possible to define a partial scope of application (e.g., cradle-to-gate, or cradle-to-grave) depending on the specific objectives of the study. MTM Consulting helps define the most suitable approach for the company’s needs.
Carbon Footprint
The carbon footprint measures the greenhouse gas emissions generated by an activity, product, or organization. It is expressed in tons of CO₂ equivalent, a value that standardizes the climate-altering potential of all greenhouse gases into a single comparable indicator.
The Product Carbon Footprint (PCF) assesses emissions throughout the life cycle of a single product, according to the ISO 14067 standard. The Organizational Carbon Footprint (OCF) measures the total emissions of a company on an annual basis, according to the ISO 14064-1 standard and the GHG Protocol.
It is not mandatory by law, but it is increasingly requested by international clients, supply chains of large companies, credit institutions with ESG policies, and public tenders. In many sectors, it is becoming a de facto requirement to qualify as a supplier.
All climate-altering gases defined by the Kyoto Protocol, including: carbon dioxide (CO₂), methane (CH₄), nitrous oxide (N₂O), hydrofluorocarbons (HFCs), perfluorocarbons (PFCs), and sulfur hexafluoride (SF₆). Each gas is converted into CO₂ equivalent based on its global warming potential (GWP).
Scope 1 includes the company’s direct emissions (e.g., natural gas combustion, company fleet). Scope 2 includes indirect emissions related to purchased electricity and thermal energy. Scope 3 collects all other indirect emissions along the value chain, both upstream (suppliers) and downstream (use and end-of-life of products).
Risk Assessment
The Employer is directly responsible for the risk assessment and the preparation of the DVR (Risk Assessment Document). This obligation is non-delegable, as established by Art. 17 of the Legislative Decree. 81/2008. They may use external consultants for the drafting, but they always remain the responsible party.
The DVR must be updated whenever working conditions change: new equipment, changes in processes, new tasks, or reports of new risks. In the absence of significant changes, a periodic update at least every 3 years is still recommended.
equipment?
Yes. The Employer must verify that the equipment is safe, suitable, and compliant with the legislation (Articles 70 and 71 of Legislative Decree 81/2008). This also applies to CE-marked equipment, whose compliance does not exempt the Employer from the responsibility for correct and safe use.
The lack of the DVR or its inadequate drafting entails criminal sanctions for the Employer, with arrest from three to six months or an increasing fine depending on the type of violation. In the event of accidents, liability can be significantly aggravated.
Machine Safety
No. CE marking declares compliance with the product directive, but the Employer must still verify the suitability, completeness of documentation, and safety of use of the equipment in their specific operational context, as provided for by Articles 70 and 71 of the Legislative Decree. 81/2008.
Annex V applies to equipment made available to workers before the entry into force of the CE product directives, and therefore lacking CE marking. The Employer must verify its compliance with the minimum safety requirements and adapt it accordingly.
The Employer has the obligation to ensure that equipment is maintained in conditions of efficiency and safety through ordinary and extraordinary maintenance and periodic checks. All maintenance activities must be documented and preserved.
Every piece of equipment must be accompanied by a user manual, a CE declaration of conformity (or of incorporation for partly completed machinery), operating instructions in Italian, and documentation proving the training of operators. MTM Consulting verifies the completeness of the documentation and supports the updating of technical files.
Manual Handling of Loads
It is mandatory whenever workers perform activities with loads that can cause biomechanical overload, even in potential form. It is an obligation provided for by Articles 167-170 of Legislative Decree 81/2008 and must be included in the company DVR.
The methods recognized by ISO 11228 standards are: NIOSH for lifting, Snook-Ciriello for pulling and pushing, and OCRA for repetitive movements of the upper limbs. The choice depends on the type of activity analyzed.
The main risks are dorso-lumbar pathologies (hernias, discopathies, low back pain), musculoskeletal disorders of the upper limbs, chronic inflammation, and acute injuries. These can permanently reduce the worker’s ability to work and generate significant direct and indirect costs for the company.
Yes. Any change in tasks, equipment, handled loads, or space layout requires a new assessment. Periodic updating is also recommended, even in the absence of obvious changes, as a good management practice.
ATEX Zoning
It is mandatory in all workplaces where there is a risk of potentially explosive atmospheres forming due to gases, vapors, mists, or combustible dusts – even just due to the presence of methane gas, forklifts, or UPS uninterruptible power supplies. It is provided for by Title XI of Legislative Decree 81/2008 and is fundamental for protecting the health and safety of workers.
The Employer has the obligation to assess the risk and classify the areas. Zoning must be performed by a competent technician, and the result must be documented in the Explosion Protection Document. MTM Consulting offers complete technical support and drafts all mandatory documentation.
If production processes, substances used, plant layout, or installed equipment change, the classification of ATEX zones must be updated. Furthermore, the ATEX CE compliance of all machines and plants present must be verified, as they may no longer be suitable for the new classification.
They are two different but related aspects. ATEX OSH zoning concerns the classification of workplaces and the obligations of the Employer (Legislative Decree 81/2008). ATEX consultancy for CE marking, on the other hand, concerns products (equipment) placed on the market (Directive 2014/34/EU). MTM Consulting specializes in both areas.
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