Machinery Regulation – designed for the future. For your medical device too?
On 29 June 2023, Regulation (EU) 2023/1230 (Machinery Regulation) was published in the Official Journal of the EU and came into force on 19 July 2023. Going forward, this regulation will replace the long-standing Machinery Directive 2006/42/EC (MD)
The legislator’s main motivation for the revision was to eliminate inconsistencies in the border area with other European legislation, including through clear differentiations in the scope of application and the introduction of new definitions. New risks in relation to the ever-increasing use of software and artificial intelligence have been taken into account and a reduction in paper-based documentation is planned as a consistent implementation of the Commission’s Green Deal.
Under certain conditions, active medical devices may fall under the definition of “machinery” and therefore this regulation. In particular, manufacturers whose products have previously been declared compliant with the Machinery Directive in addition to the MDD or MDR are affected by this change in the law and should make appropriate preparations.
Presumption of conformity for machinery
Unlike the Machinery Directive, the Machinery Regulation does not have to be implemented into national law, but applies directly to the manufacturers concerned and can only be supplemented by national law. This legal process is analogous to the replacement of the MDD/IVDD by the MDR/IVDR, which made implementation into national law by the German Medical Device Act (Medizinproduktegesetz, MPG) unnecessary and thus introduced the supplementary German Medical Device Implementation Act (Medizinproduktedurchführungsgesetz, MPDG). Accordingly, the German Product Safety Act (Produktsicherheitsgesetz, ProdSG) in its current form is no longer required for the implementation of the MDD in Germany, as the MDD is directly applicable in all European countries, however it implements far more parts of European law than just the Machinery Directive and will therefore presumably continue to exist in an amended version.
Article 1(12) of the MDR explicitly refers to the application of the MDD if the medical device also fulfils the definition of a “machine”. If this is the case, both regulations apply in parallel according to the presumption of conformity principle, as provided for in the European Union’s “New Approach”.
Therefore, the principles of the Machinery Regulation should seem familiar, whether from the machinery directive or the MDR:
- All legislation has binding essential requirements.
- If a product is subject to several regulations with presumption of conformity, the essential requirements of all applicable regulations must be assessed, whereby the strictest requirement always applies.
- Only products that demonstrably fulfil the relevant essential requirements may be placed on the market or put into service.
- The application of harmonised standards and product-specific standards leads to a presumption of conformity with these requirements.
- A conformity assessment procedure must be carried out, if necessary with the assistance of a notified body.
- At the end of the process there is always the declaration of conformity, for which the manufacturer is ultimately responsible
- Important: there is only ever one declaration of conformity for a product, and all applicable regulations must be listed that are also subject to the presumption of conformity principle.
The basic principle has therefore remained the same. The Machinery Regulation must be implemented by the manufacturers concerned in accordance with the deadlines of the Machinery Regulation, irrespective of the requirements of the MDR/IVDR.
Implementation deadlines for the Machinery Regulation
A cut-off date has been set for the transition from the Machinery Directive to the Regulation:
- Chapter VI “Union market surveillance and Union safeguard procedures” has already been in force since 19 July 2023
- From 20 January 2027, the Regulation must be applied in full.
- EC type-examination certificates and approvals issued in accordance with Article 12 of Directive 2006/42/EC shall remain valid until their expiry date.
- There are no staggered deadlines here as with the MDR.
In practice, this means that all affected products must have been converted to the regulation by the deadline: A corresponding declaration of conformity must be available for every product that falls under the scope of the MDR. Needless to say, all underlying requirements must also be met:
- The potential hazards must have been identified and minimised as far as possible through suitable measures. In other words, you should have carried out comprehensive risk management, ideally through inherent security measures.
- Based on this, all applicable essential health and safety requirements must be identified – in particular, attention must be paid here to which requirements are now more specific or additionally included in the MDR/IVDR or the MDR.
- The necessary evidence and documentation that proves fulfilment of these requirements and reflects the current state of the art, has to be available in full.
- And not to forget: The quality management system and the processes affected by the Regulation should be updated.
Innovations in the area of software and artificial intelligence
One of the Commission’s motives for adapting the legislation is the ongoing development in the field of digitalisation, which are accompanied by an increased importance of software solutions and the ever-increasing advance of artificial intelligence. Accordingly, there are several changes that take this into account:
- The definitions have been clarified – an assembly according to Article 3 paragraph 1, points a to e, which only lacks the installation of software, is to be regarded as a machine.
- Under certain conditions, a digital component can now also constitute a safety component – in other words, software that is intended to guarantee a safety function of a machine falls within the scope of the MDR under certain conditions. If self-learning systems based on machine learning are used, i.e. artificial intelligence, a notified body must be involved in the conformity assessment.
- In the case of machinery that can be connected to the internet and where software and data necessary to fulfil the relevant health and safety requirements are present, particular attention must be paid to accidental or deliberate tampering by third parties (chapter ‘Protection against corruption’ (Annex III, section 1.1.9)). The machinery or the related product must be designed and constructed in such a way that the connection of another device via any function of the connected device itself or via a remote device communicating with the machinery or the related product does not lead to a dangerous situation. Any attempt must be documented by machine for the purpose of providing evidence. Any legitimate or illegitimate intervention in the machine’s software must also be documented by machine. In addition, software and data that are essential for the compliance of the machinery or the associated product with the relevant health and safety requirements must be identified as such and adequately protected.
- The Cyber Resilience Act, which is expected to be officially published shortly, will be relevant for the defence against cyberattacks and other cybersecurity measures. In the last proposal, however, its application was not intended for medical devices. However, manufacturers should take a close look on this once again.
- The machine must identify installed software required for safe operation and make this information readily available at all times. This means that cybersecurity must be treated as an essential element in the implementation of a machine’s safety. The manufacturer must also assess the risks associated with software and AI applications, including during the learning phase. Throughout the expected life cycle, this security of software and AI applications must be ensured. The traceability log of data generated in connection with an intervention and the safety software versions uploaded after the machinery or associated product has been placed on the market or put into service must be accessible for up to five years after the upload exclusively for the purpose of demonstrating the conformity of the machinery at the reasoned request of a competent national authority. The retention period of the logs (including the AI logs) for machinery with AI applications is set at one year. For machines with AI applications, the operator must be able to intervene at any time to correct the machine.
- Initial regulations are included to avoid harmful effects through the use of artificial intelligence. With regard to the “safety and reliability of control systems”, manufacturers are required to extend their risk management to minimise hazards that could occur during the learning phase of AIs. The settings or rules that apply to the learning phase of the AI may also only be changed in such a way that no hazards are caused. The Machinery Regulation thus establishes a risk management framework for self-learning systems/artificial intelligence.
Obligations and rights of manufacturers and economic operators
Another change is that the operating instructions for machinery may in future be made available purely digitally, as may the declaration of conformity in accordance with the Machinery Regulation. Mechanical engineers are celebrating this change as a breakthrough, but it is unlikely to bring any major changes for medical device manufacturers who are also subject to the MDR. Since 2013, a purely digital IFU may only be provided for certain product types in the medical device sector under certain conditions. And the downside remains the same in every case: if the customer requests this, a paper version must be provided free of charge. Presumably, the digital form of the declaration of conformity will save a little paper.
Manufacturers must label the machinery or the product itself with their name, registered trade name or registered trade mark, postal address, website and e-mail address or other digital means of contact. If this is not possible, this information should be indicated on the packaging or on the accompanying documents. The contact details should be in a language understandable to the user and the market surveillance authority.
The new Machinery Regulation contains a few clarifications regarding the rights and obligations of economic operators. The manufacturers concerned should take a close look at these points, clearly define their own roles and, above all, review the contracts with other economic operators (authorised representative, importer, distributor). This is particularly important because the previous Machinery Directive placed some of the content relating to proof of conformity with the authorised representative, such as the creation of operating instructions or assembly instructions. This is no longer possible under the Machinery Directive. It is clearly regulated that full responsibility for such documents lies with the manufacturer. The manufacturer can certainly continue to pass these tasks on to the authorised representative as an outsourced process, but this requires an explicit contractual regulation and is no longer defined as such by a legal requirement.
Importers of partly completed machinery should also take a close look at this paragraph, as Article 14 states that only compliant partly completed machinery may be imported. Gaps due to shifts in responsibility could pose a risk here.
Furthermore, importers and distributors are now more closely involved in market surveillance, similar to medical device law. They are subject to an obligation to notify the authorities if they recognise a product risk.
Finally, with regard to the responsibilities of economic operators, it should also be mentioned that the Machinery Regulation now introduces the term “substantial modification” in Article 3.16). This does not refer to a fundamental change / versioning of the product by the manufacturer as in medical device law. In the context of the Machinery Regulation, this term means a change to the machine, whether physical or digital, which is not intended by the manufacturer, takes place after it has been placed on the market and, for example, creates new risks. If an economic operator makes such a change to the machinery, the manufacturer’s obligation will be transferred to him in future. This was stipulated in Article 18 of the Machinery Regulation.
Further amendments introduced by the Machinery Regulation
One positive aspect of the new Machinery Regulation is the clarification of the scope of application. Up to now, there have often been questions regarding the distinction between the Machinery Directive and the Low Voltage Directive (LVD) and the Radio Equipment Directive (RED). The scope of application is now as follows:
This Regulation does not apply to: …the following electrical and electronic products, insofar as they fall within the scope of Directive 2014/35/EU (Low Voltage Directive) or Directive 2014/53/EU (Radio Equipment Directive):
- household appliances intended for domestic use which are not electrically operated furniture;
- audio and video equipment;
- Information technology equipment;
- ordinary office machinery, except additive printing machinery for producing three-dimensional products;
- low-voltage switchgear and controlgear;
- electric motors
According to Annex III of the Machinery Regulation, Essential Requirement 1.5 1, the requirements for protection objectives according to the Low Voltage Directive are, however, applicable to machinery, but the conformity assessment procedure must only be carried out in accordance with the Machinery Regulation.
Structural adjustments have also been made to the content of the annexes. For example, the essential health and safety requirements can now be found in the already mentioned Annex III of the Machinery Regulation instead of Annex I, as it was previously the case with the Directive. It is a matter of getting used to this, but it is not a big deal. The same applies for the fact that all of the changes are basically details and additions. On the contrary: it is a great advantage that the new requirements do not contradict the previous ones, as this is the only way to enable manufacturers to apply the Machinery Regulation during the transition phase in order to be compliant in time for the deadline.
If your medical device is subject to the Machinery Directive/Regulation and you are now thinking: “Yet another new regulation”, we will be happy to help you. Take advantage of the remaining transition periods for the MDR/IVDR and the Machinery Regulation. Gladly together, gladly with us. Get in touch with us.
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