Applicability of Machine Directive

[AngelRose]

Good morning everyone,

I've come to question why some of our IVD products do not specify Machinery Directive in their Declaration of Conformity's applied standards. The rationale with which this was decided wasn't documented in the device's development process (Project Requirements, ecc..). In the context of a small company with a high employee turnover, nobody seems to be able to answer me definitively.

I've been trying to comprehend Directive 2006/42/EC and our device should fit under the definition of a 'machine'. I haven't found anything that excludes us from its scope yet. Some online resources mention that devices subject of the LVD Directive 2014/35/EU are exempt, but I never found an exact text that ascertains this except Article 1(2)(k): does this exclude every Low Voltage Device or specifically only the ones listed in the aforementioned article (— household appliances intended for domestic use, — audio and video equipment, — information technology equipment, — ordinary office machinery, — low-voltage switchgear and control gear, — electric motors)

Thank you in advance for any input!

 

[DanMann]

I think 1(2)(k) only excludes those types of machinery, not all Low Voltage Devices. I had a similar issue at a former employer and went with performing an in-house assessment against IEC 61010-2-120 (although it isn't harmonised) and using this as the basis of conformity assessment to the Machinery Directive.

 

[AlexisRuiz2772]

Good morning everyone,

I've come to question why some of our IVD products do not specify Machinery Directive in their Declaration of Conformity's applied standards. The rationale with which this was decided wasn't documented in the device's development process (Project Requirements, ecc..). In the context of a small company with a high employee turnover, nobody seems to be able to answer me definitively.

I've been trying to comprehend Directive 2006/42/EC and our device should fit under the definition of a 'machine'. I haven't found anything that excludes us from its scope yet. Some online resources mention that devices subject of the LVD Directive 2014/35/EU are exempt, but I never found an exact text that ascertains this except Article 1(2)(k): does this exclude every Low Voltage Device or specifically only the ones listed in the aforementioned article (— household appliances intended for domestic use, — audio and video equipment, — information technology equipment, — ordinary office machinery, — low-voltage switchgear and control gear, — electric motors)

Thank you in advance for any input!

Hi Angel.

Article 1(12) of MDR states that the essential requirements of the 2006/42/EC shall be met, as well as the GSPR of annex I in MDR.

In my case, we work with a medical device that also falls under the definition of machine according to the machinery regulation, therefore, we have in our DoC both regulations mentioned.

Moreover, take in count that there is a 'new machinery regulation' REGULATION (EU) 2023/1230 that have entered in force recently.

I would suggest to take a look directly within the regulation if something regarding the MDR is mentioned (sth similar as article 1(12) in MDR).

Sometimes, if the hierarchy of a regulation is higher than other, the one with lower hierarchy should not be met completely, usually just the essential requirements (for instance the RED directive and the Low Voltage directive, EMC directive, etc )

I hope this is helpful!

 

[CharlieUK]

As stated above, the Machinery Directive and IVD are independent and both can apply to a product.
As a minimum, the MD compliance should be supported by an EN 12100 Risk Assessment and an assessment to MD EHSR in Annex I.

Whilst the Machinery Regulation has been published, it is not applicable to products placed on the market before 14 Jan 2027

 

[AngelRose]

Thank you everyone for your precious feedback!
As it stands, I need to independently assess confomity against both IVDR GSPR and MD EHSR in Annex I.