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.

On 18 November 2024, the Commission published the new Product Liability Directive (EU) 2024/2853 in the Official Journal of the EU, which will replace the existing legislation from 1985.  Lawyer Dr Carsten Schucht has analysed the new regulation and presented the most important innovations.

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

On 6 and 7 November, a conference was held in Linz on the new Machinery Regulation (EU) 2023/1230. We have provided a brief summary of the content and some impressions in our overview.

With the new EU Machinery Regulation, digital operating instructions and declarations of conformity are permitted from the start of validity in January 2027. Providing these documents in digital form is not only intended to conserve resources, but also to increase user-friendliness and improve safety standards in mechanical engineering. In the technical article, Stefan Winkler explains the MVO's requirements for providing operating instructions and declarations of conformity and the extent to which manufacturers can already implement them under the currently valid machinery directive.

The revised standards EN ISO 14119 and EN ISO 13855 will present machine manufacturers with new challenges. With extensive adaptations to the new state of the art and a focus on risk assessments, they increase safety requirements. The technical article summarises the main changes and prepares users for the final standard editions, which are expected at the beginning of 2025.

The new Cyber Resilience Act 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 legislation for you.

On 28 October, a conference organised by IBF and Swissmem was held in Zurich on the new Machinery Regulation. In our overview, we have provided a brief summary of the content and some impressions of the second edition of the conference for you.

Material compliance is essential for companies to meet legal requirements and customer demands regarding the use of materials and substances. This compliance not only influences market approval, but also offers opportunities for innovation and sustainability. In an interview with IBF, Katrin Schneikert from Nova LoopGmbH explained what material compliance in device and machine construction means.

IBF celebrates its 30th anniversary! Since its foundation, the company has established itself as a leading provider of innovative software solutions and long-term partnerships in the field of machine safety and CE marking. In our article, we look back on the last 30 years.

Recalls are complex scenarios that do not always have to be associated with high costs if companies are well prepared. In an interview with IBF, Dr Carsten Schucht from the Produktkanzlei law firm explained the challenges to be considered in product recalls and how manufacturers can best prepare for them.

The list of harmonised standards giving presumption of conformity for the Machinery Directive 2006/42/EC has been updated: 2024-09-16

The new Machinery Regulation and other product safety regulations oblige manufacturers to carry out statutory product monitoring or, in a broader sense, ‘after-market obligations’. In an interview with IBF, lawyer Dr Carsten Schucht explains exactly what this means and what manufacturers of technical products should pay particular attention to.

The Machinery Regulation (EU) 2023/1230 requires ‘protection against corruption’ in Annex III. To cover precisely these requirements, the European Commission has commissioned a harmonised standard prEN 50742. We have summarised the background and current development status of this standardisation project in our short information.

Harmonised standards should be in place by the time the Machinery Regulation comes into force. According to the currently valid Machinery Directive, there are more than 800 such standards in the corresponding EU Official Journal. This means that by the deadline, these standards must at least be revised so that they meet the new requirements of the regulation. We have summarised the current status of the revision for you in our technical article.

On 12 July 2024, the European Commission published Regulation (EU) 2024/1689 laying down harmonised rules on artificial intelligence in the Official Journal of the EU. In our overview, you can find out what the regulatory requirements for AI systems are and what risk classifications the Commission is planning. 

At the end of April, the EU Commission published this new version 2.3 on its website. We have summarised the changes to the guide for you in a briefing note, from where you can also access the full text of the new edition of the guide.

The EU Battery Regulation aims to regulate the entire life cycle of batteries and now sets out requirements for all phases of the value chain in order to improve resource utilisation, the circular economy and safety. This technical article sheds light on the new requirements along the value chain and highlights challenges in practical implementation.

Benefit now from Safexpert's wide range of support when switching to the new Machinery Regulation. With the new version 9.1 of Safexpert, the CE Guide has been adapted to the new Machinery Regulation, among other things. This allows you to prepare for the new requirements in good time before the regulation becomes mandatory in January 2027.

On December 1, 2023, ISO, the international standardisation organisation, launched a revision of ISO 12100. You can find the most important information on the status of the revision, draft standards, changes to content and deadlines in our technical article.

The EU Product Safety Regulation 2023/988 for the first time lays down binding requirements for the content and design of recall notices in relation to non-harmonised and harmonised consumer products. Based on Art. 36 para.3 of the Regulation, the Commission has now issued Implementing Regulation (EU) 2024/1435, which sets out a template for a standardised recall notice.

Gerhard Wiebe from Produktkanzlei has summarised key data on these provisions in a technical article.

On 23 May 2023, the new Product Safety Regulation (GPSR) was published in the EU Official Journal, which will replace the previous Product Safety Directive and will apply directly in all EU member states from 13 December 2024. Dr Gerhard Wiebe has summarised the main changes that economic operators will face in this technical article.

The CE-Praxistage, the specialist conference for mechanical and plant engineering, is over. In our overview, we have compiled a brief review of the content and some impressions of the 18th edition from 11-13 June, there you will also find the dates for the 2025 conference.

The EU Commission has revised the guide to the ATEX Directive and published the new 5th edition on 26 April 2024. Our brief information provides you with an overview of the background and the most important changes.

The NIS 2 Directive defines requirements for operators with regard to cyber security. In this technical article, Martin Strommer explains which companies are directly affected (as operators) and what requirements and sanctions the directive provides for. 

On 5 March 2024, the European Court of Justice handed down its judgement in the ‘Malamud’ case. The plaintiffs had demanded that harmonised standards in the EU Official Journal must be part of EU law and must be accessible free of charge. Read our article to find out what the judgement entails and what possible consequences it may have. 

On 2 May 2024, the Commission adopted a Delegated Regulation amending the Outdoor Directive 2000/14/EC. In our technical article you will find information on the interaction of the regulation with the Machinery Directive and the Machinery Regulation, details of the planned changes and a link to the full text of the regulation..

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.

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.

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:

The list of harmonised standards giving presumption of conformity for the ATEX directive 2014/34/EU has been updated: 2023-08-02

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.

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.

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.

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

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 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.

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.

Predecessor standard, successor standard, draft standard, presumption of conformity, reversal of the burden of proof? It is not always easy to find your way through the jungle of standards. Once the right standard has been found, there are also different versions available. Can the "latest" standard simply be applied - and what do the terms "presumption of conformity" and "state of the art" have to do with it? These and other questions are answered in the following technical article.

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.

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

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 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.
 

The European Commission publishes so-called consolidated lists ("summary lists") of harmonised standards for different EU-directives. In this technical article you will find an overview containing the consolidated lists for the directives on machinery (MD), low voltage (LVD), electromagnetic compatibility (EMC), pressure equipment (PED), equipment for explosive atmoshperes (ATEX), radio equipment (RED) 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.

With their daily decisions, designers significantly influence the safety of machines and systems. This article provides an overview of the most important legal obligations that designers must at least fulfill in the product development process.

The EU Commission has revised the guidelines for the Machinery Directive and published the new version 2.1 on July 19, 2017. We provide you a list of what we believe to be the most important changes to the guide.

After the transition period for EU directives expired on April 20, 2016, which were published in the Alignment Package of the EU Official Journal L 96, and no corresponding harmonized standard was published in the course of this, which regulates the procedure for carrying out risk assessments according to the low-voltage directive, this article is intended to answer the question whether the standard EN ISO 12100 harmonized according to the Machinery Directive can also be applied to products that are subject to the Low Voltage Directive.

What significance do safety-related standards have in court judgements? The Commission for Occupational Health and Safety and Standardisation (KAN) has published a study on this important topic.