Is it possible (regulatory) to mark a device that passed the safety tests of 601-1 and 335-1 as MDD compliant and at the same time LVD compliant?:rolleyes:

Is it possible (regulatory) to mark a device that passed the safety tests of 601-1 and 335-1 as MDD compliant and at the same time LVD compliant?:rolleyes:I'm not as familiar with the Low Voltage Directive as I am with the Medical Device Directive, but there is more to the MDD than just meeting the requirements of IEC 60601-1. Why is it necessary? If you have a medical device that meets all the requirements of the MDD, you may apply the CE mark. Why not ask your notified body this question?

I did a quick little research and found the following:Annex II of the Directive lists the equipment and phenomena outside the scope of the
Directive as follows:
· Electrical equipment for use in a potentially explosive atmosphere
· Electrical equipment for radiology and medical purposes
· Electrical parts for goods and passenger lifts (elevators)
· Electricity meters
· Plugs and socket outlets for domestic use,
· Electric fence controllers,
· Radio-electrical interference, and
· Specialized electrical equipment for use on ships, aircraft or railways which
complies with the safety provisions drawn up by international bodies in which
the Member States participate.
These products are excluded from the LVD because they are regulated under national
laws, international agreements, or other New Approach Directives.I guess that answers your question.

Thanks Al,

A good example are Laser systems, they are used for a lot of medical applications, but some of the applications are cosmetic related that do not need the MDD cover.
Only for such applications there is a marketing need to expose it as LVD product.
This is the reason for me question.