The deadline for the European Medical Device Directive (93/42/EEC) was June 14, 1998.
Quite a few manufacturers were confident in the assumption that they manufacture class I products which they can self CE-mark with a minimum of outside handholding (no notified body services required). However, often they are shocked to discover that their products are considered personal protective equipment subject to Council Directive PPE 89/686/EEC. The PPE Directive went into effect July 1, 1992. Please note that it is considered illegal to CE-mark your products under the wrong directive.
But how does a manufacturer determine if PPE applies to them? May we suggest asking yourself the following questions:
1. Is the intended use of your products:
a. to treat a disease, an injury or handicap?
b. to alleviate a disease, injury or handicap?
c. to compensate for an injury or handicap?
d. to relieve pain or defeat pain cycles?
If the answer is yes to any of the above your product is definitely a medical device.
2. Is the intended use of your products:
a. to prevent an injury?
b to prevent a handicap?
c. to prevent pain?
If the answer is yes to any of the above your product is definitely personal protective equipment.
3. Is the intended use of your product to prevent a disease?
If the answer is yes, your product is a medical device or personal protective equipment depending on the intended use: a surgical mask is a medical device; a mask to protect the wearer against microbial and viral infections is personal protective equipment!
A glove for medical use in a patient’s environment is a medical device, a glove designed to provide protection against damp, heat or materials is personal protective equipment. Gloves intended for private use against adverse atmospheric conditions are excluded from the personal protective equipment directive.
Having answered these questions now review the claims your company is making in their sales and marketing brochures plus user manuals. What do they say about the intended use of these products? If you are like most companies with multiple product lines, you will discover that you probably manufacture medical devices as well as personal protective equipment and therefore need to comply with the requirements of both these directives.
One of the most challenging cases we encountered came from a manufacturer of a mouth-to-mask device which is used during CPR by medical emergency personnel. This device turned out to be designated as a personal protective product and has been assigned the highest risk classification. And watch out! The notified body you hire to certify this type of product must be an approved inspection body for this particular high risk classification. You will find that not all of them are.
There are plenty of myths plaguing industry regarding the building of technical files under the Medical Device Directive. Most are started by consultants seeking to increase billable hours, with the result that we continuously hear the same questions asked by disbelieving 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?
NO
2. Can we place a family of products in one technical file?
YES
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 language(s)?
YES
5. Do we need to show the name of a European authorized representative on the product labels?
YES
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.