MDD and Mandatory Standards (IEC/EN 60601-1-4, 60601-1-6 and ISO 14971)

[LievenDW]

This may be a stupid question, but is it mandatory for the MDD to comply with IEC/EN 60601-1-4, 60601-1-6 and ISO 14971? When I read the MDD official document, these standards are not mentioned literally.

[DannyK]

I believe it says in the MDD that you must meet the requirements of the latest harmonized standards.

[Marcelo Antunes]

Standards are voluntary. The use of harmonized standards gives presumption of conformity with the related essential principles of the directives, therefore it facilitates the process if you use them.

Please see further discussions in this topic: http://elsmar.com/Forums/showthread....965#post237965

[Alexisss]

In Reply to Parent Post by mmantunes

Standards are voluntary. The use of harmonized standards gives presumption of conformity with the related essential principles of the directives, therefore it facilitates the process if you use them.

Please see further discussions in this topic: http://elsmar.com/Forums/showthread....965#post237965

Adding to mmantunes... you must show SOMEHOW conformity with the essential requirements (annex 1) of the MDD. One way (presumption as mmantunes says) is by conforming to the harmonized standards. BUT, may be you have another way of proving conformity to the essential requirements, something that your notified body can assess and give u a CE mark for your product (if not class I).

[Marcelo Antunes]

I´m moving this thread to the CE Marking forum.

[LievenDW]

Thank you very much for your replies. This was also how I thought, but I wanted a 'second opinion'.

[Peter Selvey]

Just to clarify:

The application of harmonised standards gives you a presumption of conformity (see Article 5), which effectively absolves you of having to explain why you meet the essential requirement. In fact, you don't even need an essential requirements checklist - the list of applied standards and the "risk analysis" is enough. Only where you do not apply the harmonised standard, you are legally required to explain your alternate solution for the applicable essential requirements.

If you find this surprising and unreasonable (as I did), take a careful look at the wording in the MDD itself, for example Annex II, 3.2 (c) 2nd dash.

After digging through EU commission docs dating back to 1984 I found the reason for this, but that's too long and explanation for this post!