CE Marking - New Approach Directives

When beginning the conformity assessment procedures, you should make sure that the right people are involved. MediQuasar Consulenza is the good resolution for a problems arising from the implementation of the regulatory law, applicable to all medical devices, including IVDs and other products (cosmetics, chemist, special foods, food supplements, etc..).

Directive 93/42/EEC

The medical devices industry encompasses a wide range of healthcare products, ranging from simple bandages to more sophisticated products for sustaining life and plays key role in the diagnosis, prevention, monitoring, and treatment of diseases and the improvement of the quality of life of people suffering from disabilities.

21.09.2007 - Medical Devices - European standards Medical devices

Directive 98/79/EC

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

07.12.98 - In vitro diagnostic medical devices

Directive 76/768/EEC

The Directive determines the list of substances which are prohibited in the composition of cosmetic products (Annex II) and the substances which are subject to restrictions or specific conditions of use (Annex III). The Directive also contains lists of authorized colorings (Annex IV), preservatives (Annex VI) and UV filters (Annex VII).

01.03.2010 - Cosmetics - REGULATION (EC) No 1223/2009

Directive 2006/42/EC

Directive 2006/42/EC of the European Parliament and of the council of 17 May 2006 on machinery, and amending directive 95/16/EC

09. 06. 2006 - Machinery Directive

Engineering Medical Devices Quality Regulatory Affairs Environment Safety


The Construction Products Regulation (305/2011/EU - CPR) which repeals the Construction Products Directive (89/106/EEC - CPD) , was adopted on 9 March 2011.Under the Construction Products Regulation (Art. 10) Member States shall give information on rules and regulations for construction products. These contact points have to be established by 1 July 2013.

04.04.2011 - Construction Products Regulation