All set for the Machinery Regulation? Check now!

The Machinery Reg­u­la­tion (MR) has a clear objec­tive: machinery should not only be mechan­i­cally and func­tion­ally safe, but should also meet the require­ments of an increas­ingly dig­ital world. Cyber­se­cu­rity, dig­ital doc­u­men­ta­tion and clear processes for soft­ware updates are no longer optional extras, but a legal oblig­a­tion. This is the EU’s response to the increasing inter­con­nec­tivity of machinery and the asso­ci­ated risks.

Focus on manufacturers: Digitisation and Safety as standard

The MR opens up new oppor­tu­ni­ties for man­u­fac­turers to create modern doc­u­men­ta­tion. In future, oper­ating man­uals and dec­la­ra­tions of con­for­mity are to be made avail­able dig­i­tally – for at least ten years. Anyone who has so far relied solely on paper will need to think again.

The reg­u­la­tion also requires that Secu­rity be taken into account as early as the devel­op­ment process. Machinery must be pro­tected from manip­u­la­tion such as online cor­rup­tion or the defeat of safe­guards. Man­u­fac­turers must estab­lish clear processes for secure soft­ware updates and remote access.

Par­tic­u­larly crit­ical: high-risk machinery. In addi­tion to the con­for­mity assess­ment pro­ce­dure car­ried out by the man­u­fac­turer, it must also undergo testing by a noti­fied body. Man­u­fac­turers must check whether their prod­ucts fall into this cat­e­gory – and take the nec­es­sary steps in good time. This can be achieved by com­paring the machinery with the high-risk cat­e­gories defined in the MR and, in case of uncer­tainty, involving noti­fied bodies at an early stage.

Operators: responsibility does not end with the purchase

Oper­a­tors of machinery also have an oblig­a­tion. The MR rede­fines the term “sub­stan­tial mod­i­fi­ca­tion”. Anyone who con­verts or retro­fits machinery must check whether the con­for­mity must be assessed as a result. A con­for­mity assess­ment pro­ce­dure for machinery safety is required if a machine under­goes sub­stan­tial mod­i­fi­ca­tion or if changes are made that affect the machine’s com­pli­ance with the statu­tory pro­vi­sions for CE marking. If a sub­stan­tial mod­i­fi­ca­tion has taken place, the oper­ator becomes the man­u­fac­turer – with all the oblig­a­tions that entails.

Cyber­se­cu­rity is also a key issue for oper­a­tors. Manip­u­la­tion, cor­rup­tion and cyber attacks are real risks. The reg­u­la­tion there­fore requires mea­sures to be doc­u­mented and employees to be trained. Anyone who is neg­li­gent in this regard not only risks secu­rity gaps, but legal con­se­quences.

In addi­tion to the dec­la­ra­tion of con­for­mity, tech­nical doc­u­men­ta­tion must be avail­able at all times for all plant and machinery. For oper­a­tors, this means that processes must be designed in such a way that these doc­u­ments are readily avail­able – even years after com­mis­sioning.

Training is the key

Tech­nical spec­i­fi­ca­tions are one thing, the people behind them are another. Employees in devel­op­ment, quality assur­ance and ser­vice must be trained – par­tic­u­larly on cyber topics. This is the only way to avoid secu­rity gaps and imple­ment the new spec­i­fi­ca­tions effi­ciently. Oper­a­tors should also ensure that their teams are made aware of safe oper­ating and main­te­nance processes.

Conclusion: The clock is ticking

The Machinery Reg­u­la­tion is not a paper tiger. It will per­ma­nently change the everyday lives of man­u­fac­turers and oper­a­tors. If you act now, you can plan the tran­si­tion strate­gi­cally and secure com­pet­i­tive advan­tages. If you wait, you risk stress and costs.

---

5 tips for the next steps towards MR compliance