QNET's PPE experts can assist you in complying with the Personal Protective Equipment Directive 89/686/EEC.
Our affordable and practical approach to CE Marking of Personal Protective Equipment in accordance with the Directive meets the needs of small/medium size manufacturing companies that export to the European Union.
This CE-Marking service consists of:
Is it Personal Protective Equipment or a Medical Device?
- Organizing and preparation of the technical documentation consisting of building a technical file in accordance with the Basic Health and Safety Requirements and its applicable harmonized standards.
- Office for Regulatory Affairs in Europe that deals with the Competent Authorities on the company's behalf.
Quite a few manufacturers are shocked to discover that their products are considered Personal Protective Equipment and not a Medical Device but how does a manufacturer determine if PPE applies to them? May we suggest asking yourself the following questions:
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.
- Is the intended use of your product:
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.
- Is the intended use of your product:
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.
- Is the intended use of your product to prevent a disease:
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 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 the 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.
There are plenty of myths plaguing industry regarding the building of technical files under the PPE 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:
- Do we need to build a file for each product by size and color? NO
- Can we place a family of products in one technical file? YES
- Do we need to place the CE Mark on the product? YES ( with a few exceptions) but you will need to fulfill the requirements of the directive and draw up a Declaration of Conformity.
- Do I need to translate the labels and manuals in the national language(s)? YES
- Do we need to show the name of the European Authorized representative on the product labels? YES
- 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 Representative 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.
Contact us for more info and assistance in preparation of your technical file