Technical articles, news and publications on CE marking

On 2023-06-29, the final Regulation (EU) 2023/1230 was published in the EU Official Journal. It will come into force directly in every member state from 2023-07-19 and can be applied from 2027-20-01. The previous Machinery Directive remains in force until this date. You can find the most important information on innovations, deadlines and tips for the changeover in our technical article.

The list of harmonised standards giving presumption of conformity for the Radio Equipment Directive 2014/53/EU has been updated.

DGUV, the German Social Accident Insurance Institutions, explain the special features and potential hazards of protective screens on machine tools. Background information and a link to this publication can be found in our brief overview.

On 2023-11-21, a conference on the new Machinery Regulation 2023/1230 organised by IBF and Swissmem, the Swiss industry association for the mechanical, electrical and metal industries, took place in Zurich. In our brief overview you will find some impressions and a review of the event.

EN ISO 13849-1:2023 is the new standard for safety-related parts of control systems. To make the transition to the new requirements of the standard easier for you, we have put together some tips in an article. These include, for example, a free assignment table of the standard sections, available additional products for the standard and the new functionality from Annex A (assistance for determining the parameter P) in Safexpert.

On 2023-07-02, the Act for Better Protection of Persons Providing Information (Whistleblower Protection Act - HinSchG) came into force. In a technical article written for us, Dr. Gerhard Wiebe has analyzed the law with regard to machine law.

Benefit now from Safexpert's wide range of support when switching to the new Machinery Regulation. With version 9.1 of Safexpert, the CE Guide will be adapted to the new Machinery Regulation.

What are the concrete requirements of the future Cyber Resilience Act (CRA)? The Technical Guideline TR-03183 already communicates which cybersecurity requirements manufacturers and products will have to meet.

The list of harmonised standards giving presumption of conformity for the Machinery Directive 2006/42/EC has been updated: 2023-08-02

Must access to harmonised standards in the EU Official Journal be free of charge? The European Court of Justice (ECJ) answered this question in the negative in July 2021, citing intellectual property protection. The plaintiffs subsequently appealed against the ruling and are likely to be proven right: according to the Advocate General, harmonised standards must be accessible free of charge due to their legally binding nature! This so-called opinion is not yet final, but a new judgment of the ECJ in favour of the plaintiffs could be handed down.

In a short article, we have summarized key data on this standardization project and show how you can submit a statement or amendment proposals in an unbureaucratic manner. In addition, we have prepared the contents of the draft in a user-friendly way in the new Safexpert Knowledge Base, so that you as a user of the Safexpert StandardsManager can already get an idea of the changes:

On 25.04.2023, the Council approved the reform of the general product safety law. This clears the way for the new EU Product Safety Regulation, which will be published promptly in the EU Official Journal and is expected to apply directly from the end of 2024. Dr Gerhard Wiebe has summarised the essential innovations that will affect economic actors in this technical article.

The list of harmonised standards giving presumption of conformity for the ATEX directive 2014/34/EU has been updated: 2023-03-17

The list of harmonised standards giving presumption of conformity for the Low Voltage Directive 2014/35/EU has been updated: 2023-03-17

As of Safexpert 9.0, the software offers the function "Document comparison", which can answer the questions raised with a few mouse clicks. Details on this new function, explained on the basis of the new EN IEC 62061, can be found in our brief information.

With Service Pack 1 for Safexpert 9.0 comes an interface to the TIA Selection Tool (TIA ST) from Siemens. This interface was developed in a cooperation between Siemens and IBF. With the "Safety Evaluation" function in the TIA Selection Tool, the achieved Performance Level (PL) according to ISO 13849-1 or the achieved Safety Integrity Level (SIL) according to IEC 62061 can be calculated for a safety function.

On 28.09.2022, the Commission published its proposal for a new product liability directive to replace the existing legal act from 1985. These regulations are to be adapted to the requirements of a digital world and thus ensure a high level of consumer protection and legal certainty for all companies. Lawyer Dr Carsten Schucht has analysed this first draft and presented the most important innovations.

The EU Commission has revised the Guide to the ATEX Directive and published the new 4th edition on 28.11.2022 - for the time being only in English. In our brief information you will find the link to the original document as well as some further information.

The list of harmonised standards giving presumption of conformity for the Machinery Directive 2006/42/EC has been updated: 2023-01-10

The bundled inclusion of standard data in the EU Official Journal results not only in new publications but also in central dates for the end of the transition period. In our overview, we have clearly arranged the key dates of the so-called DOC (=Date of Cessation) for the standard data in the EU Official Journal according to the Machinery, Low-Voltage, EMC, Pressure Equipment, ATEX and Radio Equipment Directives in a timeline.

On Sept. 15, 2022, the Commission published its proposal for a regulation on horizontal cybersecurity requirements for products with digital elements, the "Cyber Resilience Act." This act addresses manufacturers, importers and distributors of digital products and will be a cornerstone in the field of digital product law as well as product compliance. Attorney Dr. Gerhard Wiebe has analyzed this draft and presented the most important regulations.

The list of harmonised standards giving presumption of conformity for the Pressure Equipment Directive 2014/68/EU has been updated.

The list of harmonised standards giving presumption of conformity for the ATEX directive 2014/34/EU has been updated: 2022-09-29

Proprietors of trademarks should closely examine the judgment of 7 July 2022 (C-264/21), in which the ECJ commented on the product liability of the so-called ‘quasi-manufacturer’. Namelythe person who does not actually manufacture a product but is nevertheless liable as the producer because he presents himself as its producer by putting his name, trademark or other distinguishing feature on the product. Dr Astrid Seehafer, attorney-at-law at ARQIS, has assessed the implications of this judgment for us.

A new CE regulation on cyber resilience? A new legislative proposal from the EU Commission aims to make digital products (such as also machines, IoT devices, but also pure software) more secure in the future. In our brief overview, we have summarized some cornerstones of the proposed legislation for you.

DGUV Test, the testing and certification system of the German Social Accident Insurance, takes a position on the subject of control systems for machines in accordance with EN ISO 13849. The statement shows whether electrical components can meet the same functional safety requirements as comparable components.

"If you say too much, you're out": This sentence can summarise the appearance of an expert witness in a material defect trial of a machine. In the trial, the expert was not allowed to point out defects such as a missing CE marking or German operating instructions. Instead, in such a process, experts must limit themselves to core contents and not address any formal obligations arising from EU directives. Prof. Dr. Thomas Wilrich has summarised the situation and the outcome of the case for us in a technical article.

What is the significance of the Radio Equipment Directive for mechanical engineering? According to the directive, the fixed installation of a radio equipment already defines a machine as a radio system. In our technical article, you will learn some background information on the interaction of the Machinery and the Radio Equipment Directive.

The list of harmonised standards giving presumption of conformity for the EMC directive 2014/30/EU has been updated: 2022-06-10

The list of harmonised standards giving presumption of conformity for the ATEX directive 2014/34/EU has been updated: 2022-05-19

The list of harmonised standards giving presumption of conformity for the EMC directive 2014/30/EU has been updated: 2022/04/13

To what extend does the Radio Equipment Directive need to consider aspects as cybersecurity and data protection? The Delegated Regulation 2022/30 has amended the Directive 2014/53/EU concerning this matter. In our short overview we have collected some background information about the legal act.

How does a harmonized standard communicate which essential requirements of the underlying directive shall be met? Herefore the European Organisations of Standardisation CEN and CENELEC generate an informative annex ZA/ZZ. Our technical article is giving some background information about development, strucutre and possible denominations of such annexes.

The list of harmonised standards giving presumption of conformity for the Machinery Directive 2006/42/EC has been updated.

The European organizations for standardization CEN and CENELEC have published a position paper on the European Commission's draft for a new Machinery Regulation. In our overview we sum up to what extend CEN and CENELEC see their interests represented by the draft and why they critizise the standards-related contents of the Commission's proposal.

The list of harmonised standards giving presumption of conformity for the ATEX directive 2014/34/EU has been updated: 2021-08-26

The EU Commission published a proposal for a new, European Regulation that deals with Artificial Intelligence (AI). In this technical article we inform about the need for regulation for AI systems, the risk assessments planned by the Commission and to what extend the regulation is intended to be a supplement to the new Machinery Regulation. 

A new edition of the EN ISO 7010 standard (Graphical symbols - Safety colours and safety signs) was published on 2020-11-01. In this article you will find some information on the new content and changes to the current standard from 2020.

Proposal for a European Machinery Regulation as successor to the Machinery Directive published! Find out how the draft affects the topics of artificial intelligence, substantial change, digital operating instructions, cobots and cyber security in a brief overview of the planned changes.

The list of harmonised standards giving presumption of conformity for the EMC directive 2014/30/EU has been updated.

The list of harmonised standards giving presumption of conformity for the Machinery Directive 2006/42/EC has been updated.

The list of harmonised standards giving presumption of conformity for the Pressure Equipment Directive 2014/68/EU has been updated.

The list of harmonised standards giving presumption of conformity for the Low Voltage Directive 2014/35/EU has been updated.

ISO, the International Organization of Standardization, has created the ICS catalogue system, which facilitates the classification and finding of standards. In this article, you will find the details regarding this system and how the search for standards can be improved.

The list of harmonised standards giving presumption of conformity for the Low Voltage Directive 2014/35/EU has been updated.

New standards for the directive  2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment was published: 2020-18-05

The list of harmonised standards giving presumption of conformity for the EMC directive 2014/30/EU has been updated.

Important facts about safety distances to avoid crushing of limbs. Which safety distances must be observed when designing machines. The new standards EN ISO 13854 and EN ISO 13857 provide an important fundament for this.

The list of harmonised standards giving presumption of conformity for the Pressure Equipment Directive 2014/68/EU has been updated.

The standard for the development of instruction handbooks for machinery (EN ISO 20607) was published in the EU Official Journal. What this means and how the standard interacts with EN 82079-1.
 

Recently the publication of harmonized standards within the Official Journal of the EU occurs via amendments (by means of Implementing Decisions). In the meantime, consolidated lists ("summary lists") have been published for different EU-directives. In this technical article you will find an overview containing the consolidated lists for the directives on machinery, low voltage, electromagnetic compatibility (EMC), pressure equipment, equipment for explosive atmoshperes (ATEX) and restriciton of hazardous substances (ROHS).

The EU Commission has revised the guidelines for the Machinery Directive and published the new version 2.2 on November 6, 2019. Here we provide you with a list of what we consider to be the most important changes in the guide.