MDD Introduction

The medical devices directive (MDD) 93/42/EEC was the second medical devices directive and was fully implemented in June 1998. It covers all medical devices used on humans not covered by the other two directives. This covers the majority of medical devices sold. Notified Body certification is required for all Class 1 (sterile or measuring function), Class IIa, Class IIb and Class III devices. A few medical devices are also covered by other EC Directives and manufacturers must then comply with both Directives.

As the scope of this directive is wide, covering medical devices as diverse as electrical equipment, wound dressings, implants, sterile single use products and disinfectants, it potentially overlaps with many other EC regulated products. These other regulated products include cosmetics, pharmaceuticals, biocides, consumer products and personal protective equipment some of which are CE marked and some of which must not be CE marked. It is illegal to CE mark a product that should not be CE marked, illegal to CE mark under the incorrect directive and illegal not to use the CE mark when required.

Most products that are covered by this directive are classified into four classes of increasing risk, Class I, IIa, IIb and III. Directive 93/42/EEC contains 19 rules in Annex IX that allow correct classification but interpretation needs experience and knowledge of the many guidance documents. Classification is important to allow the choice of the correct Notified Body certification.

Certain small groups of devices are covered by this directive but do not need CE marking including devices for clinical investigation, custom made devices and systems/procedure packs.

As both the scope and classification of medical devices is complicated, it is essential that manufacturers new to CE marking seek advice at an early stage.

Products conforming with the MD Directive must have a CE mark applied. The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on March 21, 2010.

Why choose Jiushun Enterprise Management?

Jiushun Management has determined the medical device consulting with adequate and systematic service as its major service since found on August, 1996. Jiushun has developed to be the one of the most qualified, widest service-providing and most customers in the Greater China (including Hong Kong, Macao andTaiwan).

We have provided the specialized service for more than 5,000 customers from the Greater China, UK, U.S.A, Japan, Singapore, Malaysia, etc. spreading all over the world, including 15 listed companies.