(A.) Policy and legislation

(A.1) Policy objectives

Industry is central to Europe’s economy. It contributes to Europeans’ prosperity through business in global and local value chains and provides jobs to 36 million people – one out of five jobs in Europe. In particular, the manufacturing sector is hugely important because of its major role in driving productivity and innovation. An hour of work in manufacturing generates nearly EUR 32 of added value. With a share of approximately 16% of the total value added, manufacturing is responsible for 64% of private sector R&D expenditure and 49% of innovation expenditure. Every new job in manufacturing creates between 0.5 and 2 jobs in other sectors. More than 80% of EU exports are generated by industry. Recent years have seen impressive growth rates in labour productivity, namely 2.7% per year growth on average since 2009.

Advanced manufacturing addresses the evolution of the manufacturing industry towards a new level of digitalisation, including intelligent production, process handling, and integration. This progression is driven by the application of ICT in manufacturing and includes any optimisation solution improving productivity, quality, and flexibility in the entire manufacturing lifecycle. To enhance sustainability, the manufacturing lifecycle must prolong the life of durable industrial products in compliance with circular economy objectives. To lower waste and pollution, and use energy in smarter ways, it should take into account operations such as testing and diagnosis, disassembly/repair/upgrade, and recycling.

Nowadays, work pieces and semi-finished products involved in the manufacturing lifecycle often possess information on themselves and suitable means of communication, i.e. they have cyber-physical characteristics. These products can control not only their logistical path, but rather the entire lifecycle workflow from operating to maintenance, dismantling and recycling.  Decentralisation of the digitally stored information could logically be followed by decentralisation of control systems.

The European policy on advanced manufacturing focuses on fostering the development and speeding up of the uptake of innovative technologies by the European industry. This ambition unfolds in three objectives: accelerate the dissemination and commercialisation of advanced manufacturing technologies, boost the demand for advanced manufacturing technologies, and reduce skills shortages and competence deficits.

This follows the overall Digitising European Industry (DEI) objectives: to reinforce the EU’s competitiveness in digital technologies and to ensure that every industry in Europe, in whichever sector, wherever situated, and no matter of what size can fully benefit from digital innovations. The DEI initiative does not focus on certain digital technologies, nor is it limited to one or a few industrial sectors. However, several DEI actions are specifically targeted at the manufacturing sector.

European manufacturers would benefit from more automated flexibility and data intelligence in supply chains. Agile manufacturing (e.g. reacting to changes in demand, in labour or in material resources available) would enable smarter logistics and lower production costs. Industrialising and digitising the complete manufacturing lifecycle including circular economy operations would enable a smarter use of energy and resources, while maintaining competitiveness in costs and quality. Simulations or rapid prototyping methods like 3D printing would enhance the design process. Big data analytics, turning the data stored in clouds to intelligence, would provide insights on achieving cost and carbon emission reductions. Eventually, an internet of manufacturing things (better known as the Industrial Internet of Things) would provide for smooth communication between the various machines of an intelligent supply chain, building on the increased presence of sensors and actuators.

There are a number of initiatives around advanced manufacturing in Europe, in the Member States and also outside Europe (see B.2). The objective at the European level is to strengthen the coordination among the various initiatives and to facilitate the deployment of advanced manufacturing at a pan-European level, thus improving the competitiveness of the European manufacturing industry both in the Single Market and on a global scale, and creating the conditions for the European technology providers to flourish.

Advanced manufacturing technologies are one of the key enabling technologies (KETs) identified by the Commission as key to competitiveness36. In 2015, the global market for KETs was estimated to be more than EUR 1 trillion. KETs have huge potential for growth and employment. According to the European Competitiveness Report 2013, depending on the KET, growth potentials of 10 — 20% per year can be expected over the coming years. For particular submarkets, the growth potential is even larger. Countries and regions that fully exploit KETs will be at the forefront of advanced and sustainable economies. KETs deployment will contribute to achieving reindustrialisation, energy, and climate change targets simultaneously, making them compatible and reinforcing their impact on growth and job creation. 

An analysis is underway whether to revise the Machinery Directive. Depending on the outcome of this analysis – and subsequently on whether a revision of the Machinery Directive needs to be undertaken – standardisation activities in the context of the Machinery Directive may arise.

(A.2) EC perspective and progress report

Standards can play a key role in accelerating the effectiveness of supply chains in manufacturing systems. In some cases, standardisation can also play a stabilising role of research activities on which real market opportunities may then be built on. The opportunity is to ensure Europe’s technological leadership through the massive integration of ICT into advanced manufacturing technologies, systems and processes.

The amount of communication between machines, sensors and actuators is increasing and will continue so. Machines will become increasingly self-organised as well as their supply chains, from design to warehousing until delivery of a product. IoT technologies will play a major role to support this. Securing high-speed communications infrastructures (e.g. broadband infrastructures) is vital. The specific industrial needs and requirements concerning, for example, availability, security and functional safety have to be taken into account in order to make these technologies suitable for advanced manufacturing. Moreover, the supply chains increasingly need flexibility in design to answer to individual customer requirements (mass customisation). Easier and cost-effective product differentiation is a key for growth. Additive manufacturing (3D printing) may push differentiation to a further stage of individualisation, generating a market of cloud-based production and retailing.

There is a need to promote the development of interoperability standards and European reference architectures, as well as open digital manufacturing platforms, including experimentation, validation, interoperability testing facilities and trusted labels and certification schemes.

The take-up of advanced manufacturing solutions will dramatically accelerate if they are compatible with the installed manufacturing base, and the related standards and technical specifications are coherent with the existing ones, e.g. on machinery, tools, digitalisation. In this respect, standardisation is of central importance since the success of advanced manufacturing demands an unprecedented degree of system integration across domain borders, hierarchy borders, and life-cycle phases. Consensus-based standards and technical specifications, and the close cooperation among researchers, industry and SDOs are the pre-requisites to ensure fruitful results especially in this domain.

Several research-oriented activities were launched under H2020:

  • I4MS (Innovation for Manufacturing SMEs) is an EU initiative dedicated to the manufacturing sector and in particular to its high-tech SMEs. I4MS is part of the public-private partnership “Factories of the Future” (PPP H2020 FoF). 
  • Funded projects on flexibility and adaptability in the production chain (CloudFlow, INTEFIX, APPOLO), simulation (Fortissimo, CloudSME), robotics (EUROC) and data intelligence (LASHARE).
  • The EFFRA (European Factories of the Future Research Association) developed a roadmap for the development of Factories of the Future by 2020 in the framework of H2020.
  • SPIRE (Sustainable Process Industry through Resource and Energy efficiency) is a public-private partnership that represents more than 90 industrial and research process industry stakeholders from over a dozen countries across Europe.
  • In addition lighthouse pilot projects in the framework of the Joint Undertaking on Electronic Components and Systems for European Leadership (ECSEL) will provide for validation of standards for future markets, including large-scale experimental test-beds.
(A.3) References 

The following list is a non-exhaustive overview of initiatives at a national level:

(B.) Requested actions

Action 1 Common communications standards and a reference architecture for connections between machines (M2M) and with sensors and actuators in a supply chain environment are a basic need and a priority. Specific industrial needs must be included, like standards which support communications on broadband infrastructures and data formats in order to allow for the quick transfer of large volumes of data over networked industries. This could ease the ability to switch between platforms. 

Analysis is required as to how to provide industries with a solution enabling wireless communications without interfering with other wireless networks. In particular, a check should be run on M2M standards against requirements like real-time capability and close to hardware runtime codes. 

Action 2 As part of the new skills agenda for Europe, ESOs could check whether the e-skills standards sufficiently account for the manufacturing skills of KETs, including future manufacturers, M2M, rapid prototyping and others.

Action 3 Conduct a study to identify and analyse opportunities for revisions of existing standards (communications, M2M) or new standards with a particular view on new production technologies, manufacturing processes including lifecycle operations (circular economy), functional safety issues and skills-deficit reduction.

Action 4 Improve interoperability and reduce overlap, redundancy and fragmentation. Often there are several standardisation activities ongoing in the same area in parallel. Standardisation activities should be encouraged for making standards to work together and integrating existing protocols. Moreover, standards bodies should aim for a coordinated approach regarding different reference architectures and measures should be taken to reduce overlap, redundancy and fragmentation.

Action 5 Interoperable and integrated security - SDOs should work on interoperability standards for security and for linking communication protocols in order to provide end-to-end security for complex manufacturing systems including the span of virtual actors (from devices and sensors to enterprise systems). Standards should take into account risk management approaches as well as European regulation and regulatory requirements.

Action 6 Create a hierarchical catalogue of technical and social measures for assuring privacy protection and task all SDOs impacting the DEI domain in general and the advanced manufacturing domain in particular to comment on and prioritize the elements in the catalogue. Digitising industry implies processing of data which includes personal data within the definition of the GDPR. That means, in addition to technical measures to ensure the security of the data, additional technical and social measures are needed to protect the privacy of personal data. Such social or non-technical measures will include, e.g. Codes of Conduct, Charters and Certifications, best practice guidelines, collection of evidence of privacy protection assurance, etc.

Action 7 Standards should be developed to define the main characteristics for all levels of the interaction from mechanical to electrical to protocol to semantic levels between robot and tool to ensure the exchangeability and to enable the design of generic tooling (plug-and-play). There are 2 main types of End Effector. “Off-the-Shelf” and “bespoke”. It is desirable that off-the-shelf end effectors operate on a single software protocol. There is a need for Industry 4.0 to standardise this. It would then become Plug-&-Play. For “Bespoke” end effectors (most commonly purchased) the system integrator specifies the software protocol for the Robot and End Effector.

Action 8 Start the discussion about the possible development of harmonised standards in the area of additive manufacturing. Currently, there are no harmonised standards under the Machinery Directive for Additive Manufacturing (AM) equipment. The availability of these standards could facilitate the manufacturer conformity assessment process. The European Commission should discuss together with SDOs and AM equipment manufacturers the possible need for harmonised standards in this area.

Action 9 SDOs to develop standards or expand available standardisation efforts for including topics of relevance to circular economy, in particular long-term traceability of material to enable re-use and recycling.

(C.) Activities and additional information  

(C.1) Related standardisation activities

DIN and DKE founded the Standardisation Council Industrie 4.0 (SCI 4.0) in conjunction with the industry associations BITKOM, VDMA and ZVEI.

SCI 4.0 is responsible for orchestrating standardisation activities and, in this role, acts as a point of contact for all matters relating to standardisation in the context of Industrie 4.0 nationally and on international scale.

In collaboration with the Plattform Industrie 4.0, SCI 4.0 brings together the interested parties in Germany and represents their interests in international bodies and consortia. SCI 4.0 also supports the concept of practical testing in test centres by initiating and implementing new informal standardisation projects tailored to meet specific needs. http://www.sci40.com


CEN/TC 438 ‘Additive Manufacturing’ has been working since 2015 to standardize the process of AM, their process chains (hard and software), test procedures, environmental issues, quality parameters, supply agreements, fundamentals and vocabularies. CEN/TC 438 works closely with ISO/TC 461 in cooperation with ASTM F42. CEN/TC 438 will develop new projects that relate to aeronautic, medical, 3D manufacturing and data protection.

CEN/TC 310 “Advanced Automation Technologies and their applications” has been working since 1990 to ensure the availability of the standards the European industry needs for integrating and operating the various physical, electronic, software and human resources required for automated manufacturing.  It works closely with ISO/TC 184 and other committees to achieve international standards wherever possible in order to meet the needs and opportunities of the global market, as well as establishing common European strategies wherever possible. A key tactic is to use the Vienna agreement process to initiate work in Europe to exploit the results of R&D projects and promote them to the ISO level at the earliest opportunity.


CENELEC/TC 65X “Industrial-process measurement, control and automation” works out methods for safe and secure communication protocols for wired and wireless industrial automation applications some of which are included in the 2,4 GHz industrial, scientific and medical radio band (ISM).

The EN 62264 series ‘Enterprise-control system integration’ relate to the overall design architecture in the context of Industry 4.0. The series provide requirements for information flow in a manufacturing environment, and address IoT and Cybersecurity. ‘

  • EN 62264-3:2017 ‘Enterprise-control system integration - Part 3: Activity models of manufacturing operations management’
  • EN 62264-4:2016 ‘Enterprise-control system integration - Part 4: Object model attributes for manufacturing operations management integration’
  • EN 62264-5:2016 ‘Enterprise-control system integration - Part 5: Business to manufacturing transactions’

ETSI ERM TG 11 is currently working on methods to improve the politeness of existing adaptive and non-adaptive mechanisms and to consider the inclusion of alternative mechanisms taking into account the needs of the wireless industrial applications operating in the 2,4 GHz ISM band.

ETSI ERM TG 41 is currently working on harmonised standards for wireless industrial applications in the frequency range 5725 MHz to 5875 MHz.

ETSI DECT has started the development of DECT-2020, a 5G radio interface operating on license exempt spectrum that will support Ultra Reliable and Low Latency use cases required by Industry Automation scenarios. 

ETSI DECT has started the development of DECT-2020, a 5G radio interface operating on license exempt spectrum that will support Ultra Reliable and Low Latency use cases required by Industry Automation scenarios.  <<ADD AFTER EXISTING DECT TEXT>>

ISG F5G is addressing the use of fibre for industrial application to connect with the highest bandwidth and most secure technology each equipment in industrial production.


ISO/TC 184 deals with industrial automation technologies, including automated manufacturing equipment, control systems and the supporting information systems, communications and physical interfaces required to integrate them in the world of e-business


Projects include:

ISO 6983-1:2009 — Automation systems and integration -- Numerical control of machines -- Program format and definitions of address words -- Part 1: Data format for positioning, line motion and contouring control systems

ISO 14649 (series of standards): Industrial automation systems and integration -- Physical device control -- Data model for computerized numerical controllers

ISO 22093:2011 — Industrial automation systems and integration -- Physical device control -- Dimensional Measuring Interface Standard (DMIS)

ISO 23570 (series of standards): Industrial automation systems and integration -- Distributed installation in industrial applications

ISO 13584 (series of standards): Industrial automation systems and integration -- Parts library

ISO 10303 (series of standards): Industrial automation systems and integration -- Product data representation and exchange

ISO 16100 (series of standards): Industrial automation systems and integration -- Manufacturing software capability profiling for interoperability

IEC/TC 3/SC3D” Product properties and classes and their identification”

ISO Strategic Advisory Group Industry 4.0/Smart manufacturing (ISO /SAG)

ISO/TC 261 works on standardisation in the field of additive manufacturing concerning their processes, terms and definitions, process chains (hard- and software), test procedures, quality parameters, supply agreements and all kind of fundamentals.


IEC/TC 65 “Industrial process measurement, control and automation”, with its sub-committees, provides an extensive set of standards for manufacturing, including standards addressing cyber security (IEC 62443 series), functional safety (e.g. IEC 61508, IEC 61511) or interoperability (e.g. IEC 62541 (OPC)), and others.

Several groups of IEC/TC 65 and its subcommittees are involved in the development of standards for advanced manufacturing, foundational/structuring groups like SC 65E/AhG 1 “Smart manufacturing information models”, TC 65/WG 23 “Smart manufacturing framework and system architecture”, SC 65E/JWG 5 “Enterprise-control system integration”, SC 65E/WG 9 “AutomationML — Engineering Data Exchange Format”, operational groups like TC 65/WG 16 “Digital Factory”, TC 65/WG 19 “Life-cycle management for systems and products”, SC 65E/WG 8 “OPC” and communication groups, including real-time communications work, SC 65C/WG 9 “Industrial networks — Fieldbusses”, SC 65C/WG 16 “Wireless” and SC 65C/WG 17 “Wireless coexistence”.

IEC systems evaluation group (SEG) 7 on smart manufacturing has been created to organise the transition from SG 8 to a systems committee (SyC). Among its tasks, SEG 7 will focus on: 

  • providing an inventory of existing standards and current standardisation projects under the management of IEC, ISO and other SDOs.
  • expanding on the definition of common value chains within a smart manufacturing enterprise, as identified in SG 8, and identifying associated use-cases which will assist in determining the state of the art in the industry, and the identification of potential gaps where IEC standardisation is needed with respect to smart manufacturing.
  • establishing an initial roadmap of smart manufacturing standardisation, architecture and prospective standardisation and conformity assessment projects to be conducted by the SyC member TCs and partners.
  • delivering a dashboard to cross reference the project work items to documented use-cases within particular value chains to assist standards developers and industry stakeholders to navigate the domain

ISO/IEC JTC 1/WG 12 3D Printing & Scanning:  WG 12’s focus is on the ICT foundational aspects of 3D printing standardisation. In the area of 3D printing and scanning, WG 12 develops standards and/or suggests work for other existing JTC 1 subgroups. WG 12 makes recommendations to JTC 1 to suggest delegation of work to other existing JTC 1 subgroups. It also leads or coordinates JTC 1 liaisons with ISO, IEC and external organizations working on projects in 3D printing and scanning.

Current projects: JTC 1/WG 12 has commended standardisation development in the area of additive manufacturing service platforms and medical image-based modelling 


IEEE has standards activities relevant to the digitisation of industry/advanced manufacturing, including basic horizontal standards applicable to many industry domains, such as standards for networking and sensors, as well as specific standards addressing the needs of the manufacturing sector, like production process automation in a plant.

IEEE Working Groups evolve legacy standards and start new standardisation projects for smart manufacturing in support of:

  • Industrial Services
  • Intelligent Factories
  • Intelligent Equipment
  • These are complemented by standards for the
  • Industrial Internet
  • Industrial Software and Big Data

Some key enabling standards for Digitisation of European Industry include the following:

  • The IEEE 802.1 Time-Sensitive Networking (TSN) family of standards provides deterministic connectivity to time and mission-critical industrial applications over IEEE 802.3 Ethernet networks. A joint Working Group with IEC SC 65C is developing IEC/IEEE 60802 TSN Profile for Industrial Automation to enable the logical configurations and re-configurations of communication systems supporting advanced manufacturing.
  • The “Standard for Sensor Performance Parameter Definitions” Working Group develops IEEE 2700 “IEEE Standard for Sensor Performance Parameter Definitions”, a common framework for sensor performance specification including terminology, units, conditions and limits.
  • The “Quality of Data in the IoT Environment” Working Group is developing the IEEE P2510 “Standard for Establishing Quality of Data Sensor Parameters in the Internet of Things Environment” project to define quality metrics such as speed, location, and temperature for sensor data needed to improve the quality of the analytics decisions being made.
  • The “Intelligent Process Automation” Working Group develops a family of standards for software-based intelligent process automation technologies. IEEE Std 2755-2017 specifies terms, capabilities and concepts and IEEE 2755.1-2019 classifies approximately 150 features and functions across five core technology areas, and IEEE P2755.2 “Recommended Practice for Implementation and Management Methodology for Software Based Intelligent Process Automation (SBIPA)” is under development.
  • The “Online Detection” Working Group is developing IEEE P2671 “Standard for General Requirements of Online Detection Based on Machine Vision in Intelligent Manufacturing” project and the “Mass Customization” Working Group is developing the IEEE P2672 “Guide for General Requirements of Mass Customization”.
  • The “Digital Representation” Working Group is developing IEEE P2806 “System Architecture of Digital Representation for Physical Objects in Factory Environments”.
  • The “DevOps” Working Group is developing IEEE P2675 “Standard for DevOps: Building Reliable and Secure Systems Including Application Build, Package and Deployment” to specify technical principles and practices to build, package and deploy systems and applications reliably and securely. Its process outcomes and activities are aligned with the process model specified in ISO/IEC/IEEE 12207:2017 “Systems and software engineering - Software life cycle processes”, and in ISO/IEC/IEEE 15288:2015 “Systems and software engineering — System life cycle processes”.

For a list of these and other standardisation activities on the Digitisation of European Industry, please visit: https://ieeesa.io/rp-digitization


ITU-T SG20 on “Internet of Things and smart cities and communities (SC&C)” provides a specialized IoT standardisation platform for the development of a cohesive set of international standards on IoT and smart manufacturing. SG20 has approved one Recommendation on “Overview of smart manufacturing in the context of the industrial Internet of things” (ITU-T Y.4003). It also has ongoing work on Framework and capabilities for smart livestock farming based on Internet of things (Y.IoT-SLF)


ITU-T SG13 approved Recommendation ITU-T Y.2238 on Overview of Smart Farming based on networks. SG13 has a work in progress on Unmanned Smart Farm (Y.esm, Y.ous). Also under development is a Recommendations on requirements and architecture of Digital Twin Network (Y.DTN-ReqArch) and an application of a u-learning environment to the smart farming (Y.sfes).

Supplement 67 to Y.3000-series of ITU-T Recommendations “Representative use cases and key network requirements for Network 2030” elaborates the use case description and key network requirements for digital twin.



The OASIS Production Planning and Scheduling TC develops common object models and corresponding XML schemas for production planning and scheduling software, which can communicate with each other in order to establish collaborative planning and scheduling on intra and/or inter enterprises in manufacturing industries.

The OASIS Product Life Cycle Support (PLCS) TC established structured data exchange and sharing to support complex engineered assets throughout their total life cycle. It created Data Exchange Specifications (DEX’s) based upon ISO 10303 (STEP) Application Protocol 239 (Product Life Cycle Support), in liaison with ISO TC 184/SC4.


The oneM2M Basic Ontology specification enables semantic and syntactic interoperability across the IoT. This will become increasingly important as greater quantities of data are generated and shared across the IoT.

oneM2M has been designed for interworking: so it lends itself to be used as a factory hub aggregating modern equipment (e.g. OPC-UA based), legacy controllers and the plethora of sensors that are being added to equipment to provide input for innovative applications and whose characteristics and usage do not match well with many of the controllers that are commonly used. It is used, e.g., in BaSys 4.0, the Industrie 4.0 open-source middleware that has been funded by the German Federal Ministry of Education and Research (BMBF) since 2016, whose implementation is available as Eclipse Project BaSyx.

Furthermore, the interconnection capabilities that facilitate interoperability among smart cities also enable oneM2M to be used to support the operations of distributed, coupled supply chains.

These characteristics have been outlined in a recent study by ETSI (ETSI TR 103 536 - Strategic / technical approach on how to achieve interoperability/interworking of existing standardized IoT Platforms)


Web of Things http://www.w3.org/WoT/


Developing test beds and contributing to reference architecture and use-case development http://www.iiconsortium.org/test-beds.htm

(C.2) additional information

There are three basic principles behind standardisation of advanced manufacturing technologies:

  • accelerate the dissemination and commercialisation of advanced manufacturing technologies,
  • boost the demand for advanced manufacturing technologies, and
  • reduce skills shortages and competence deficits.

In industrial automation, it is essential for the vast variety of systems from various manufacturers to interact in a reliable and efficient manner. The users, operating globally, expect to be able to source their usual products and systems everywhere in the world. In order to ensure this global usability and consistency across different systems, international standardisation in industrial automation has always been regarded as especially important and pursued as a matter of a priority. Nowadays, standards are available or are at least being drafted to cover important issues in industrial automation. But again and again new technologies and new requirements create a new demand for standardisation. This requires the development of a host of new concepts and technologies. However, it will only be possible to implement these new concepts and technologies in industrial practice if they are backed by standards based on consensus. Only such standards are able to create the necessary security for investments and confidence among manufacturers and users.

Development of new technologies and intensifying the relationships between more and different actors in the value chain require not only new standards but also updating, maintenance and even re-design and integration of existing standards.

Additional communication capabilities and a (partial) autonomy to react to external influences and internally stored specifications are transforming mechatronic systems into cyber-physical systems. The objectives derived from that transformation are developments and adjustments in ICT for manufacturing applications: robustness, resilience, information security and real-time capability. In addition, increasing improvement is aimed for energy and resource efficiency, and in the adjustment of industry to accommodate the social demands arising from demographic change.

With regard to machine-to-machine communication, consideration should be given to the framework of metadata. There may be a role for standards in developing an accepted architecture building on existing agreed terminology.

36 See also https://ec.europa.eu/futurium/en/implementing-digitising-european-industry-actions/national-initiatives-digitising-industry