THE MACHINERY DIRECTIVE (2006/42/EC)

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).

Click the button below and contact us for a personalized consultation! 

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:

1. The 2014/34/EU regarding the regulation of equipment used in areas at risk of explosion. It sets out the minimum requirements for explosive environments and the essential safety requirements that manufacturers must meet before selling or operating machinery designed for such environments.
 
2. The 99/92/EC which deals with the safety and health of workers in explosive atmospheres, with the aim of minimizing the risk of those who work in this type of environment.

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!

mtm consulting: an all-around support

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.

Our services include:

• Creating the risk assessment document
• Preparing the technical file
• Developing the instruction manual
• Providing a template for the EU Declaration of Conformity
• Supplying a template for the CE plate
• Designing and implementing production control systems
• Assisting in interactions with notified bodies

That's not all! Beyond CE marking

• Are you exporting machinery, equipment, or plants to the UK? mtm consulting srl can help you adapt your machines and equipment to meet the UKCA marking requirements, even for potentially explosive environments. Click HERE to learn more about our services!

• Looking to train your team in the ATEX field? We offer a modular training course that can be accessed online or conducted at your company (available only in Italian).

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.

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. 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.

Our services include:

• Preparing the risk assessment document
• Creating the technical file
• Developing and/or translating the instruction manual
• Supplying a template for the EU Declaration of Conformity
• Offering a sample CE plate
• Designing and implementing production control systems
• Providing assistance in dealing with notified bodies

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:

• Checking compliance with quality management system standards (ISO 13485).

• Creating technical documentation and applying the CE marking to the medical devices. This documentation, also known as the technical file, includes all the necessary documents that manufacturers must keep demonstrating compliance with regulations and avoid penalties.

Depending on the medical device classification, it may require certification by a notified body or self-certification according to product technical standards (for 1^st-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:

• Unlimited email-based questions related to Directive 2006/42/EC, sent to a dedicated address.

• A complete and professional response within 48 hours from our expert technicians.

• Written information about changes to Directive 2006/42/EC, including effective dates, explanations, and their impact on your situation.

• An updated list of new standards harmonized with Directive 2006/42/EC, replacing the old ones.

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.

Our consultancy

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.

• life cycle assessment
• quantified ecological profile development
• evaluation of alternative design scenarios with energy and environmental considerations
• preparation of technical documentation
• implementation of management systems
• drafting of declarations of conformity
• support with translation into the destination country's language

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:

• Draft a Declaration of Performance (DoP) to take responsibility for the product's performance.
• Successfully complete the CE marking process.
• Verify and certify the constancy of performance.
• Provide traceability of the product in case of non-compliance.

Our consultancy

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:

• Designing production control systems.
• Assisting with test laboratories and notified bodies.
• Creating use and maintenance manuals.
• Translating texts into different languages.

Want to learn more? Click the button below and reach out to us for a personalized consultation!

THE UKCA MARKING OF MACHINES AND PARTLY-COMPLETED MACHINES

With the officialization of Brexit at the beginning of 2020, the United Kingdom has exited the European Union, leading to the discontinuation of adherence to European Product Conformity Standards. Therefore, the CE marking is being replaced by the new UKCA marking.

Starting on October 1, 2024, not only will it still be possible to place CE-marked machines on the British market, but a new “fast-track” procedure will also be introduced. This allows the use of the UKCA marking even if the product has been manufactured in compliance with European directives. Manufacturers can simply affix the UKCA marking to their products and provide a UK declaration of conformity.

Importers in the UK will still have the same responsibilities, and manufacturers must prepare the required documentation in English. Besides, the UKCA and CE conformity assessment procedures can be combined when products are subject to multiple regulations.

Please note that this flexibility in using the CE and UKCA markings does not apply to certain products, such as medical devices and construction products.

It is also important to remember that:

·       If you import a machine manufactured in Great Britain to the EU, it must have the CE marking, as the European Union does not recognize the UKCA marking.

·       Northern Ireland (Ulster) is an exception and continues to maintain CE marking and adherence to EU standards. 

At mtm consulting srl, we have closely monitored the evolution of the UKCA marking for machinery since its introduction to assist companies in staying informed of the latest developments. For more information or specialized advice on this topic, please feel free to contact us by clicking the button below. 

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!