Clarification for certain products under PPE 89/686/EEC -- MEDICA - World Forum for Medicine


Obelis European Authorized Representative Center (O.E.A.R.C.)

Clarification for certain products under PPE 89/686/EEC

The Personal Protective Equipment Directive (PPE 89/686/EEC)

covers products used for personal health and safety for work, home

or leisure. The European Commission remains active in initiating

directives that improve personal protection and prevention as such;

the PPE Directive sets requirements for products to have the

highest level of protection against hazards. There are many

unique products that fall under the scope of PPE and the

classifications for each product can vary.

The main clarification for the classification of PPE deals with

facemasks. Facemasks are certainly a type of personal protective

equipment, however if the facemask is intended to be used for

medical purposes it will be classified as a Class I medical

device. It is important for manufacturers to properly classify

their products so as to follow the correct compliance route and

abide by the EU harmonized standards.

Classification can be a complex issue but it is a first and key

step in the regulatory process for obtaining CE marking and selling

products in the European Union. In fact the essential steps to

obtain CE Marking are as follows:

1. Classify your product

2. Ensure product compliance (this step also requires you

to appoint a European Authorized Representative)

3. Obtain/maintain technical documentation

4. CE Marking/Labeling

5. Post Market Surveillance and Incident Reporting

Obelis European Authorized Representative Center has provided

superior regulatory consultancy services to manufacturers worldwide

for over 19 years. In fact, Obelis offers identification of

product classification as a FREE service. In order to get

expert guidance and proper classification for your product, please

contact Obelis at Furthermore, Obelis’ services

cover the PPE directive and offers professional, regulatory and CE

marking solutions for category I, II and III Personal Protective

Equipment (