The Machinery Directive: Which Parts Apply to Medical Devices?

The Machinery Directive (2006/42/EC) is generally applicable to machines of all types. However, the directive can also be relevant for medical device manufacturers: both the MDR and the IVDR refer to it.

If the Machinery Directive comes into play, requirements that go beyond those of the MDR and IVDR apply. Therefore, this article will give you an overview of:

• When medical devices fall under the Machinery Directive
• Which requirements you have to take into account
• How you demonstrate conformity
• What the EU is planning for the future of the Machinery Directive

1. When you have to comply with the Machinery Directive

The Machinery Directive, published by the EU in 2006, is intended to ensure a uniform level of safety for machinery in Europe. As a general regulation for machines of all types, it deals with a wide range of hazards.

Medical devices can also be responsible for such hazards. To ensure that the uniform level of safety also applies in the case of medical devices, both the MDR and the IVDR refer to the directive.

The wording of Art. 1(12) of the MDR and Art. 1(6) of the IVDR is identical and indicates when manufacturers have to comply with the Machinery Directive:

„The Essential Health and Safety Requirements of the Machinery Directive, therefore, also apply to medical devices if the following conditions are met:

1. The device is machinery according to Art. 2(2)(a) of the Machinery Directive and

2. A relevant hazard under the machinery directive may occur and

3. The Essential Health and Safety Requirements of the Machinery Directive contain more specific requirements than the general safety and performance requirements of the MDR.”

a) Condition 1: the medical device is considered machinery

The Machinery Directive defines “machinery” in Art. 2(2)(a).

A machine generally consists of 

1. An assembly
   This consists of at least two parts that are connected for a specific purpose.
2. A drive system
   At least one of the parts is driven. The driving force does not come from humans or animals, but from other energy sources, such as electrical, pneumatic, hydraulic, mechanical or thermal energy sources.
   Products for lifting operations are an exception to this rule. Human power can also be the driving force in this case.

Art. 2(2)(a) defines machinery in detail as:

- an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application,

- an assembly referred to in the first indent, missing only the components to connect it on site or to sources of energy and motion,

- an assembly referred to in the first and second indents, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure,

- assemblies of machinery referred to in the first, second and third indents or partly completed machinery referred to in point (g) which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole,

- an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort;

The specific types of hazards covered by the Machinery Directive are listed in Annex I of the Directive. If the medical device generates a hazard listed there, the second condition is also met.

c) Condition 3: the Machinery Directive contains more specific requirements

As a final requirement for the Machinery Directive to apply to medical devices, the regulations in Annex I of the Machinery Directive must be more specific than those in Annex I Chapter II of the MDR or IVDR.

Therefore, which requirements are more specific has to be decided on a case-by-case basis by comparing the essential requirements of the Machinery Directive with those of the MDR and/or IVDR.

Requirements that are regulated more precisely in the MDR and IVDR than in the Machinery Directive

MDR

• Biological and chemical hazards
• Hazards associated with software
• Hazards associated with usability
• Hazards due to radiation
• Electrical hazards 

IVDR

• Robotic systems used to automate an IVD kit (liquid handling robotics)
• Microscopes with movable slide tables and automatic lenses

In these cases, manufacturers must comply with the MDR/IVDR.

Requirements that are regulated in more detail in the Machinery Directive than in the MDR or IVDR

• Mechanical hazards
• Safety and reliability of control systems and protective devices
• Risks from moving parts
• Information and warnings

In these cases, manufacturers must comply with the Machinery Directive.

2. What requirements does the Machinery Directive place on medical devices?

a) Only the specific requirements in Annex I are relevant

If medical devices fall under the Machinery Directive, the specific requirements of the directive apply to them.

However, manufacturers are not required to check the entire directive. Both the MDR and the IVDR only refer to Annex I of the Machinery Directive. This means:

• They only have to take Annex I of the Machinery Directive into account.
• They only have to take into account the requirementsthat go beyond those of the MDR or IVDR (see Condition 3).

b) Risk assessment

In Annex I, Machinery Directive lists the specific requirements for products. As a first requirement, the directive states that the relevant risks must be identified and assessed.

For the risk assessment, the Machinery Directive establishes specific requirements. However, they are in line with those of the MDR or IVDR.

They oblige the manufacturer to:

— determine the limits of the machinery, which include the intended use and any reasonably foreseeable misuse thereof, 

— identify the hazards that can be generated by the machinery and the associated hazardous situations, 

— estimate the risks, taking into account the severity of the possible injury or damage to health and the probability of its occurrence, 

— evaluate the risks, with a view to determining whether risk reduction is required, in accordance with the objective of this Directive, 

— eliminate the hazards or reduce the risks associated with these hazards by application of protective measures, in the order of priority established in section 1.1.2(b). 

Source: Machinery Directive Annex I, General Principles

c) Health and safety requirements

The Machinery Directive distinguishes between health and safety requirements that apply to all machinery and those that only apply to specific machinery.

General health and safety requirements

The first part of Annex I of the Machinery Directive contains the general requirements that manufacturers must always take into account.

These are essentially the principles of safety integration that also apply to medical devices:

• Eliminate or reduce risks
• Take the necessary protective measures in relation to risks that cannot be eliminated
• Inform users of the residual risks

The general part also specifies further requirements for:

• Usability
• Accompanying documents and information
• Warnings and labeling
• Operating instructions

These requirements are also already familiar to medical device manufacturers from other regulations.

Specific health and safety requirements

The other parts of the Annex refer to specific hazards. They, therefore, only apply to machines for which the hazards listed in them can occur.

Specific hazards include:

• Hazards due to the mobility of machinery
• Hazards due to lifting operations
• Machinery intended for underground work
• Hazards due to the lifting of persons

Therefore, manufacturers must take both the first part as well as the other parts of the Annex into account. They should check which hazards apply to their product when doing so. This will then tell them which requirements they must meet according to the Machinery Directive.