New Machinery Regulation 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. More
Material Compliance in machine and equipment manufacturing 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. More
The 10 key questions on recall obligations 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. More
New standards for the Machinery directive published: 2024-09-16 The list of harmonised standards giving presumption of conformity for the Machinery Directive 2006/42/EC has been updated: 2024-09-16 More
Product monitoring and aftermarket obligations 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. More
Standardisation project for ‘protection against corruption’ 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. More
New Machinery Regulation - Status of harmonised standards 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. More
Artificial Intelligence (AI) Act published 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. More
Guide to the Machinery Directive in new edition 2.3 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. More
CE conformity of the Battery Regulation 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. More
New Machinery Regulation - Support from Safexpert 9.1 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. More
EN ISO 12100 is being revised 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. More
Standardised template for a recall notice according to the Product Safety Regulation 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. More
New Product Safety Regulation (GPSR) 2023/988 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. More
These were the CE - PraxisTage 2024 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. More
New guide (5th edition) to the ATEX Directive 2014/34/EU published 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. More
New standards for the Low Voltage Directive (LVD) 2014/35/EU published: 2024-04-23 The list of harmonised standards giving presumption of conformity for the Low Voltage Directive 2014/35/EU has been updated. More
NIS 2 Directive and mechanical engineering 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. More
Will harmonised standards in the EU Official Journal soon be free of charge? 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. More
Amendment of the Outdoor Directive 2000/14/EC 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.. More
New standards for the Radio Equipment Directive published: 2023-12-01 The list of harmonised standards giving presumption of conformity for the Radio Equipment Directive 2014/53/EU has been updated. More
Protective vision panels at metalworking machine tools 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. More
Review: Conference on the new Machinery Regulation 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. More
New edition of EN ISO 13849-1 (Safety-related parts of control systems) - support from IBF 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. More
The Whistleblower Protection Act from the Perspective of the New Machinery Regulation 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. More
TR-03183: Requirements of the future Cyber Resilience Act (CRA) 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. More
EU Advocate General: Standards must be free of charge 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. More
Draft standard EN IEC 62061:2021/prA1 (functional safety) published 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: More
New standards for the ATEX Directive published: 2023-08-02 The list of harmonised standards giving presumption of conformity for the ATEX directive 2014/34/EU has been updated: 2023-08-02 More
We digitise standards - using the new EN IEC 62061 as an example 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. More
New in Safexpert: Plug-in for the TIA Selection Tool from Siemens 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. More
New Product Liability Directive On 28 January 2024, the Commission published the current compromise text on a new product liability directive, which is intended 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. More
DOC summaries for harmonised standards 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. More
Draft EU Cyber Security Regulation 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. More
New standards for the Pressure Equipment Directive published: 2022-10-03 The list of harmonised standards giving presumption of conformity for the Pressure Equipment Directive 2014/68/EU has been updated. More
Product liability of the quasi-manufacturer 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. More
The new Cyber Resilience Act A new CE regulation on cyber resilience? 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. More
DGUV statement on proven components according to ISO 13849 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. More
Experts in CE and product safety processes "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. More
The significance of the Radio Equipment Directive in mechanical and plant engineering 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. More
New standards for the EMC directive published: 2022-06-10 The list of harmonised standards giving presumption of conformity for the EMC directive 2014/30/EU has been updated: 2022-06-10 More
Does the Radio Equipment Directive (RED) demand the implementation of security? 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. More
Essential requirements of directives and standards: the meaning of annex ZA, ZB or ZZ in harmonised standards 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. More
CEN and CENELEC’s position paper on the European Commission’s draft for a new Machinery Regulation 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. More
Safety signs: new version of the standard EN ISO 7010 published 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. More
Draft of a new machinery regulation published 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. More
Standards topicality vs. presumption of conformity - Which information is relevant? 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. More
The easier way to find standards: International Classification of Standards (ICS) 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. More
New standards for RoHS directive published: 2020-18-05 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 More
Safety distances – Update of Standards EN ISO 13854 and EN ISO 13857 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. More
EN ISO 20607 "Safety of machinery - Instruction handbook - General drafting principles" is now listed as a harmonized standard to the Machinery Directive 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. More
Consolidated lists ("Summary lists") of harmonized standards available 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). More
New (Guide) 2.2 to the Machinery Directive 2006/42/EC 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. More
Safety of machinery – designers’ duty! 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. More
New (Guide) 2.1 to the Machinery Directive 2006/42/EC 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. More
Risk assessment according to the Low Voltage Directive: CE marking of electrical devices - legal obligation to assess risks 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. More
Standards in jurisdiction 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. More