High-risk machines EU type-examination certificate

The technical requirements for machines and mechanisms are established by harmonized EU legislation (machine safety, electromagnetic compatibility, operating noise, potentially explosive atmospheres) and by the national requirements of each country.

Regulatory systems vary slightly from country to country, creating additional costs and administrative burdens for manufacturers. The lack of uniformity in requirements delays the introduction of new products in the EU and is a barrier to market entry. Manufacturers incur additional costs, in particular because they have to comply with different national requirements.

Regulation 2023/1230 ensures the direct and uniform application of procedures and requirements. The technical requirements are very detailed and, in practice, leave no room for discretion on the part of Member States. The Regulation defines technical safety requirements, the main content of which is that machinery and mechanisms must be designed, manufactured and assembled in such a way as to minimise the risk of injury to users and other persons.

The Machinery Directive includes a conformity assessment procedure but does not contain a clear classification of high-risk machinery.

Annex I to the Machinery Regulation contains a list of machinery subject to type approval. Mandatory involvement of conformity assessment bodies will apply to certain types of products. The European Commission may update the list of type-approved machinery by means of delegated acts. The conformity of type-approved machinery is verified by a notified body. This ensures the highest possible level of safety.

The Regulation contains a provision on the EU type-approval procedure. Under EU type-approval, the conformity assessment body issuing the approval will issue a certificate confirming that the type of machinery complies with the relevant provisions of the Regulation.

The type-approval body will issue an EC Type-Examination Certificate and monitor product conformity. The Commission will be empowered to adopt delegated acts laying down detailed mechanisms for ensuring product conformity in the context of EU type-examination certificate.

EU Regulation 2023/1230 on machinery will enter into force on 20 January 2027 and replace the current EU Directive 2006/42/EC on machinery. This means that EU Directive 2006/42/EC on machinery will remain in force until 19 January 2027. From 20 January 2027, the EU Directive on machinery and mechanisms will be replaced by the EU Regulation on machinery and mechanisms, and from that date onwards, the new regulation will become mandatory.

EU Regulation 2023/1230 on machinery and mechanisms replaces the previous Directive on machinery and mechanisms and introduces stricter, clearer and more uniform safety requirements for machinery manufacturers.

The most important differences are:

1. The regulation covers new risks arising from new technologies.

2.            It removes legal uncertainties arising from a lack of clarity regarding the scope of application and definitions.

3. It closes potential safety gaps in traditional technologies.

4. It creates adequate conditions for high-risk machinery.

5. It eliminates financial and environmental costs by documenting on paper.

6.            Eliminates differences in interpretation of provisions arising from their implementation in national legislation.

Economic operators, notified conformity assessment bodies and market surveillance authorities have until 20 January 2027 to prepare for the new requirements.