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The new EU Machinery Regulation 2023/1230 will result in changes to the signing of the EU declaration of conformity. While the previous Machinery Directive 2006/42/EC still required a specific person to compile the technical files, this wording can no longer be found in the text of the new regulation. This technical article summarises in detail the changes that this will bring for authorised representatives in the area of communication.
The requirement known from the Machinery Directive 2006/42/EC for a "person authorised to compile the technical file" (Annex II, A.) no longer exists under the Machinery Regulation (EU) 2023/1230. This requirement was a unique feature of the Machinery Directive and has now been adapted to the "New Legislative Framework".
This person has been replaced by the requirement ‘The address shall indicate a single point at which the manufacturer can be contacted.’ (Article 10 and Article 11, paragraph 6). These contact details are no longer indicated in the declaration of conformity, but manufacturers indicate their name, registered trade name or registered trade mark, postal address, website and e-mail address or other digital contact details at which they can be reached. This must be indicated either on the machine or the associated product itself or, if this is not possible, on the packaging or in the documents accompanying the machine or the associated product.
This means that the relevant national authorities will in future contact manufacturers via the e-mail address provided (or another digital contact option).
At the reasoned request of the manufacturer, the manufacturer must provide all information and documents in paper or digital form in a language that can be easily understood by that authority, which are necessary to demonstrate the conformity of the machine or associated products with the Machinery Regulation. Manufacturers "shall cooperate with that authority, at its request, on any actions taken to eliminate the risks" posed by their machinery or related products that they have placed on the market or put into service, the Machinery Regulation continues (Article 10, Paragraph 10).
So what are the tasks of the manufacturer or the person internally designated by the manufacturer?
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Who can and must be the manufacturer? The Machinery Regulation clearly names the manufacturer, the authorised representative, the importer and also the distributor, depending on which economic operators are involved. In principle, this task is the responsibility of the manufacturer of the machine or the associated product.
If a machine manufacturer based outside the EU decides to market its products in the EU, Article 4 (1) of the Market Surveillance Regulation (EU) 2019/1020 states that "a product subject to legislation (...) may be placed on the market only if there is an economic operator established in the Union who is responsible (...)."
The importer is also responsible if he places a product from a third country that falls within the scope of the Machinery Regulation on the market in the EU. And distributors are also intended for this task in Articles 15 and 16 of the Machinery Regulation.
In this article, the term "manufacturer" is used below, although the aforementioned economic operators may also be meant. According to the EU Commission, it must be the "manufacturer" or one of the above-mentioned economic operators if they are involved – this is not very helpful, because it means every employee of the company.
As a manufacturer, you must ensure internally that enquiries from the relevant national authorities reach the right people in the company via the contact options provided by them. There must always be a person in your organisational structure who provides the necessary documents to the authority and works with them. However, this person no longer has to be formally named beforehand – neither in the declaration of conformity nor in other documents.
If the task consists of providing all the information and documentation required to demonstrate the conformity of the machine or the associated product with the Machinery Directive, in paper or digital form, in a language that is easy for this authority to understand, then this must be possible. To do this, three things are required:
Manufacturers provide all information and documents upon reasoned request. A list of the responsible national authorities can be found on the site of the European Commission.
As a manufacturer, it is important to know that only the "national" market surveillance authority can request the above-mentioned documents, e.g. if there are doubts regarding the conformity of the machine with the essential health and safety requirements.
You can voluntarily provide other parties – e.g. the business partner or the injured party – with all the information and documents required to prove the conformity of the machine, e.g. the risk assessment, e.g. on the basis of a contractual agreement. The Machinery Regulation does not provide for an obligation to provide private individuals with all the information and documents required to prove the conformity of the machine.
Furthermore, companies are well advised to keep the technical files available for their own purposes. The files should make it possible to prove that a machine was in a certain condition at the time of placing on the market. When it comes to clarifying who is responsible for an accident (e.g. one that was caused or facilitated by the manipulation of safeguards), the technical files can therefore be an important piece of evidence for manufacturers.
If the market surveillance authorities require the manufacturer's risk assessment or other technical files, they will write to the manufacturer itself, i.e. the company1. It is then "the company's responsibility to ensure, through organisational measures, that letters addressed to its registered office are forwarded to the responsible person"2.
These examples show that for several years now, since the national implementation of the Machinery Directive 2006/42/EC has been in force, some courts have handled the matter in such a way that the national authority responds directly to the manufacturer and not to the documentation officer upon a reasoned request.
The ‘internal person in charge of assembly’ is, like any other employee of a company, responsible to the employer under labour law. However, whatever he fails to do, does too late or does incorrectly is attributed to the company and cannot be asserted against him personally:
Footnotes:1 As in the case of the Administrative Court of Düsseldorf, judgment of 26 February 2019 (Ref. 3 K 9147/18).2 This is what the Gelsenkirchen Administrative Court says, judgment of 23 February 2021 (Az. 14 K 3990/20) – permissible addressing of the hearing form and the3 For a detailed discussion, see Wilrich, Arbeitsschutz-Strafrecht – Haftung für fahrlässige Arbeitsunfälle: Sicherheitsverantwortung, Sorgfaltspflichten und Schuld – mit 33 Gerichtsurteilen (2020).
Posted on: 2024-12-13
Wolfgang Reich CE marking and safety expert HTL electrical engineering, specialising in power engineering (Dipl.-HTL-Ing.), 20 years of experience in CE marking, machine safety, conversion of machines, electrical engineering and explosion protection, 10 years of which at TÜV Austria and Intertek Deutschland GmbH. Chairman of the master craftsman examination commission in the Styrian Chamber of Commerce for mechatronics (automation technology and electronics).
E-Mail: wolfgang.reich@ibf-solutions.com
Prof. Dr. Thomas Wilrich Active around the topics of product safety, product liability, occupational health and safety and distribution of goods including the corresponding company organisation, contract drafting, damages and executive liability, insurance issues and criminal defence. He is responsible for business, labour, technical and corporate organisation law as well as "Law for Engineers" at the Faculty of Industrial Engineering at Munich University of Applied Sciences.
Email: info@rechtsanwalt-wilrich.de | www.rechtsanwalt-wilrich.de
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