mtm consulting srl is a leader in providing consulting and training services for the CE marking of equipment and industrial machines.
100% compliance guaranteed! We provide manufacturers and users with the assurance of adherence to all relevant legislative requirements through our consulting and document drafting services.
Take a look at the menu on your left to discover all our services in detail, or simply click the button below to contact us and schedule a consultation with no obligations.
THE MACHINERY DIRECTIVE (2006/42/EC)
On June 29, 2023, the new Machinery Regulation 2023/1230 was officially published, which had been circulating for several years as a provisional draft.
However, it will only become fully effective 42 months after that, specifically on January 20, 2027.
For now and until that date, Directive 2006/42/EC is still in effect.
If you want to stay informed and clear any doubts during this critical transition phase,
click HERE to explore our helpdesk service!
Directive 2006/42/EC is a product directive applicable to everything that falls within the broader definition of "machinery" (which includes interchangeable equipment, safety components, lifting accessories, etc.) or "partly completed machinery".
It was created with the aim of guaranteeing people's safety during all phases of a machine's life: transport, handling, installation, use, maintenance, uninstallation, and disposal. In fact, the Machinery Directive sets out the important safety and health requirements that manufacturers need to follow before their machines can be used or sold in the EU.
In order to meet these requirements, it is mandatory to have the CE marking, which allows you to use and/or sell the machine.
mtm consulting: an all-around support
For over 20 years, mtm has been providing support to many different companies throughout the CE marking process for various roles, such as manufacturers, resellers, authorized representatives, importers, and distributors. We assist them with compliance with the Machinery Directive (2006/42/EC) and help in creating the necessary documentation for CE marking and the CE Declaration of Conformity.
Our services include:
✓ Risk assessment document preparation.
✓ Estimating PLr and calculating PL according to UNI EN ISO 13849-1:2016.
✓ Creating the technical file.;
✓ Drafting and translating instruction manuals.
✓ Providing a template for the EC Declaration of Conformity.
✓ Providing a template for the CE marking plate.
✓ Measuring and reporting airborne noise emissions.
✓ Designing and implementing production control system procedures.
✓ Assisting with interactions with notified bodies (for machines in Annex IV).
That's not all! Beyond CE marking
In addition, mtm also offers the following services:
✓ Assistance in securing machines built before 1996, as per the provisions of Annex V of Legislative Decree No. 81/2008. Click HERE e to learn more.
✓ Support in adapting to the UKCA marking when importing machinery, equipment, or plants into the UK. Click HERE to learn more.
✓ Dedicated training courses on the Machinery Directive, both online and organized at your company (available in Italian only).
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THE ATEX DIRECTIVE (2014/34/UE)
The term ATEX (from the French Atmosphères et Explosives) is the conventional name that brings together two EU directives relating to the installation and use of machineries in potentially explosive atmospheres:
Machineries are categorized according to the level of hazard in the environment (Zones) where they will be used. These categories help determine the necessary level of protection for the machinery and the safety procedures to follow.
Each machine is then CE marked in accordance with Directive 2014/34/EU for its specific operating area. If the machine is moved to a different environment with a different classification, it is important to verify if the existing protection category is suitable. If needed, the machine should be remarked for the appropriate category.
Which zone is my machine in?
If you're unsure about the classification of the area where your machine will be placed, mtm consulting srl can help. We can assess the area and provide the necessary documentation for the zoning process, as required by Legislative Decree 81/2008. Click HERE to learn more about our services!
Whether you are a manufacturer, reseller, authorized representative, importer or distributor, for over 20 years mtm has been accompanying you in all phases of the CE marking of your machineries, equipment and industrial plants to be installed in areas classified as at risk of explosion, so that they can be used safely and calmly.
Furthermore, we not only offer strategic assistance to comply with the ATEX 2014/34/EU Directive, but we also work closely with the customer to create the required documentation for CE marking and the EU Declaration of Conformity.
That's not all! Beyond CE marking
THE PED DIRECITVE (2014/68/UE)
The Pressure Equipment Directive 2014/68/EU, better known by the acronym PED, is an EU product directive that regulates the design, manufacturing, and assessment of pressure equipment and assemblies with a maximum allowable pressure higher than 0.5 bar.
Under the PED Directive, manufacturers need to determine the level of hazard associated with the equipment they produce according to the energy stored in the equipment.
For over 20 years, mtm has been providing support to many different companies throughout the CE marking process for various roles, such as manufacturers, resellers, authorized representatives, importers, and distributors. In addition to our strategic support to comply with Directive 2014/68/EU, we also work closely with our customers to create the necessary documentation for CE marking and the EU Declaration of Conformity.
Want to learn more? Click the button below and reach out to us for a personalized consultation!
MEDICAL DEVICES CE MARKING (R. 2017/735)
In the European Union, medical devices undergo a conformity assessment to ensure they meet safety and performance requirements.
This assessment involves:
Depending on the medical device classification, it may require certification by a notified body or self-certification according to product technical standards (for 1st-class devices).
To comply with regulations, the device documentation needs to include all required information as outlined in Regulation R.2017/745. This includes device identification (such as the UDI code), description, intended use, labeling, information on design and manufacture, risk management, verification and validation of the device, and post-market surveillance planning.
For more information, visit the news section of our website (available in Italian only), or click the button below to contact us and receive specific advice on this topic.
HELPDESK AND REGULATORY UPDATE SERVICE
For those in need of targeted consultancy and efficient, rapid, and continuous support, mtm consulting offers the Helpdesk and Regulatory Update service. Our experienced senior technicians are dedicated to assisting you with any questions regarding the CE marking of your machines and industrial plants. They will also keep you updated on any changes to the Machinery Directive 2006/42/CE.
Our service includes:
To learn more about the service and its value, please contact us by clicking the button below.
THE ERP DIRECTIVE (2009/125/EC)
The acronym ERP, which stands for Energy Related Products, refers to all those products that consume energy, such as equipment that relies on energy, devices that generate, transfer, or measure energy, and other equipment that directly impacts energy consumption.
Directive 2009/125/EC, in effect since 2015, aims to establish minimum standards for environmentally friendly design and improved efficiency of these products since they consume a large portion of natural resources and energy.
Similar to directives for Machinery, ATEX, and PED, manufacturers falling under the scope of Directive 2009/125/EC have the obligation to ensure their products comply. This involves placing the CE marking on the product, providing a Declaration of Conformity, and creating a technical file to demonstrate compliance.
At mtm consulting srl, we have been assisting manufacturers, retailers, authorized representatives, importers, and distributors in the CE marking process for ERP products for over 20 years.
Want to learn more? Contact us for a personalized consultation by clicking the button below!
THE CONSTRUCTION PRODUCT REGULATION (EU REG. NO. 305/2011)
European Regulation 305/2011/EU ensures the safety and quality of construction products in the European Union. It sets out minimum standards for products used in construction, such as buildings and civil engineering works. These standards cover areas like mechanical resistance, stability, fire safety, hygiene, and energy savings.
To comply with the regulation, manufacturers must:
mtm offers consulting services for complying with this regulation. We support manufacturers, retailers, authorized representatives, importers, and distributors in all phases of CE marking for construction products.
Some specific services we provide include:
THE UKCA MARKING OF MACHINES AND PARTLY-COMPLETED MACHINES
In November 2022, the British government has announced that the use of the UKCA marking for most products placed on the English, Scottish, and Welsh markets has been postponed for two years.
This means that until December 31, 2024, both the CE and UKCA markings will be accepted for importing products into the United Kingdom.
Starting January 1, 2023, the United Kingdom, no longer part of the European Union, will replace the CE marking with its own UKCA (UK Conformity Assessed) marking.
This means that:
Please note: The only exception to these rules is Northern Ireland (Ulster), which will still follow CE marking and Union standards.
At mtm consulting srl, we have been preparing to assist you throughout this tricky transition period. To learn more or receive dedicated advice, click the button below to contact us.
NON-EU MACHINERY AND PARTLY COMPLETED MACHINERY IMPORTATION
Importing machinery from non-European Union (EU) markets, such as China, is becoming increasingly common. This practice is driven by both cost considerations and the desire to acquire machinery that is not readily available on the EU market.
To ensure a smooth import process from non-EU countries, it is crucial to have a comprehensive understanding of the Community Regulations and apply them correctly. This knowledge will help avoid any unforeseen issues when dealing with Customs.
When it comes to machinery, it is important to note that for them to be legally placed on the EU market or used within EU territory, they must bear the CE marking and comply with the Machinery Directive 2006/42/EC and any other relevant community directives. This requirement applies regardless of whether the machines were manufactured within or outside the EU.
It is worth highlighting that if the machine manufacturer is not based in the European Community, the importer holds specific responsibilities regarding the market placement of the machine. Therefore, it is essential to carefully evaluate the machines and the associated documentation before proceeding with the import.
Our consultancy: mtm consulting srl
To ensure a correct assessment of the machines and their compliance with applicable directives and regulations, we offer our 20+ years of experience in the field of machine safety and conformity within the EU. We offer a specialized consultancy service that provides importers with a clear understanding of the compliance status of the documents before importation.
Our service includes:
✓ A comprehensive evaluation of all relevant documentation related to the machines.
✓ A technical report certifying the actual compliance state with the applicable directives and regulations.
✓ Our digital document validation service.
Would you like to learn more? Please contact us by clicking the button below!
DIGITAL DOCUMENT VALIDATION: 1CEIN.com
At mtm consulting srl, we not only provide consulting and document drafting services, but we also offer a validation certificate for the content of the documents we produce. That's because we are confident in the high quality of our services and that your products will comply with the applicable regulations.
Furthermore, we can also validate the content of existing documents created by you or third parties after checking their quality.
Our validation service has two main benefits:
Assures that your product conforms to the relevant directives and regulations.
Demonstrates that you have correctly followed the CE procedure, including the necessary documentation, without the need to share it with third parties (customers, supervisory authorities, branches, representatives, importers, exporters, etc.). Confidentiality is important to us!
Our validation service also includes access to our validation platform, which allows you to download and verify the validation certificates in just a few clicks. Moreover, you have the option to handle everything independently if you prefer.
Please note that this service is also available for UKCA marking.
If you would like to learn more, click the button below to contact us for more information!