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Medical Device or Personal Protective Equipment?

Medical Device or Personal Protective Equipment?

ieving manufacturers who are pretty steamed about the "high entry costs" to enter the European market. It really doesn’t have to be that way. Some of the questions most often heard are:

1. Do we have to build a file for each product by size and color?


2. Can we place a family of products in one technical file?


3. Do we need to place the CE-Mark on the product?

YES with a few exceptions, but you have to fulfill the requirements of the MDD and draw up a declaration of conformity.

4. Do we need to translate the labels and manuals in the national languages?


5. Do we need to show the name of a European authorized representative on the product labels?


6. Can we designate one of our distributors or agents as our authorized representative?

YES, any distributor or agent you so designate is acceptable, but there are also independent authorized representatives companies who offer a variety of services. One of the major advantages of using an independent authorized representative is non-modification of labels etc. when you decide to make changes to your distribution network. But then again, if you appoint each distributor/agent as an authorized representative for their territory you may need to carry a substantial inventory of different labels. Only you, the manufacturer, have sufficient sales vs. cost data to make these decisions.

7. Does our company, a class I Medical device manufacturer, have to be ISO 13485 certified?

NO, providing your Class I products are not sterile and do not have a measuring function and you can prove that the products meet the MDD requirements.

8. Do we need to add the "declaration of conformity" to each product?

NO, providing your authorized representative keeps the declaration available for the national authorities.

Complying with the Medical Device Directive for class I medical products is not complicated nor does it have to be expensive. But on the side of caution, the one strong recommendation we make is that you have or consult with a certified auditor, with documented MDD experience, to perform a desk audit of your technical files.

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