Rank: New forum user 
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Hi All,
I work in a manufacturing plant for medical devices.
In terms of our machinery/equipment that is used for the production of our products, any machine we buy should be CE marked. (as it was placed on the market)
What about machines which are developed by our own engineers for:
(a) research and development purposes.
(b) used in production but only by us.
Machines developed in-house would be small desktop items for lets say as an example, putting a bend on the tip of a piece of wire.
What are the requirements? Will a risk assessment from our health and safety officer suffice? Any help or advice would be greatly appreciated.
FF.
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Rank: Super forum user
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From memory, I think you are in a bit of a grey area here.
For example machines used for display/trade shows can be exempt from CE marking - I can't remember if this exclusion also applies to research & development machines/purposes.
Also working within medical devices, again these may fall into one of the excluded categories - but not sure about the machines used to produce medical devices - probably not is my guess.
Suggest you download a copy of the Supply of Machinery Regulations and the associated EU MAchinery Directive guidance from the EU website - it is easy enough to find by Mr Google.
Enjoy the reading.
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Rank: Super forum user
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Try this document
Guide to application of the Machinery Directive 2006/42/EC - 2nd Edition - June 2010
THis comment is made in the document
Directive 98/37/EC was subject to a minor amendment by Directive 98/79/EC relating
to the exclusion of medical devices.
Also
Medical Devices Directive (93/42/EC)
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Rank: Super forum user
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finianfahy wrote:Hi All,
What about machines which are developed by our own engineers for:
(a) research and development purposes.
(b) used in production but only by us.
What are the requirements? Will a risk assessment from our health and safety officer suffice? Any help or advice would be greatly appreciated.
FF. CE marking is primarily required for equipment to be placed upon the market in the EU. With regards to your R&D etc., the Health and Safety at Work Act, PUWER and Management of Health and Safety at Work Regs still apply and therefore you must keep your employees safe so far as is reasonably practicable. Depending on what you are making and your precautions etc., of course other regulations may apply as is relevant. Of course as you stated, equipment you buy in will have to be CE marked, e.g., you buy in a power supply to power your R&D equipment. Regards.
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Rank: Super forum user
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I should add to my comments that CE marking is also associated with putting equipment into service for the first time. So with regards to your 'production' if you are now in proper production, i.e., you are not just running the equipment to continue with the R&D, then I would suggest that you need to CE mark.
Regards.
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Rank: Super forum user 
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Somewhere (and I can't remember where) in the mire of EC and .gov guidance is a statement to the effect that the Directives apply to the in-house circumstance you describe.
In other words, the machines must meet the essential safety requirements of all relevant Directives.
The employer can of course self-declare - OK for simpler machines as you describe?
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Rank: Forum user
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FF,
I am currently looking at this with regards to our tooling assemblies that we designed, had manufactured and are using for our production only. I am using 'Guide to application of the Machinery Directive 2006/42/EC' which I downloaded from the internet. It is a bit of a tome but reading relevant paragraphs I have found that it depends on the type of tooling whether it comes under this Directive or not. For example some of our equipment is for lifting purposes and these come under these regs (as well as other regs.). However simple holding fixtures dont, it didn't take too long to identify what was relevant and what was not.
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