Essential Requirements
What are the general technical requirements to bring my medical device product to the European market?
DIRECTIVE 98/79/EC
(18 June 2009)
ANNEX I
ESSENTIAL REQUIREMENTS
B. DESIGN AND MANUFACTURING REQUIREMENTS
1. Chemical and physical properties
1.1. The devices must be designed and manufactured in such a way as to achieve the characteristics and performances referred to in section A on the ‘General requirements’. Particular attention must be paid to the possibility of impairment of analytical performance due to incompatibilitybetween the materials used and the specimens (such as biological tissues, cells, body fluids and micro-organisms) intended to be used with the device, taking account of its intended purpose.
1.2. The devices must be designed, manufactured and packed in such a way as to reduce as far as possible the risk posed by product leakage, contaminants and residues to the persons involved in the transport, storage and use of the devices, taking account of the intended purpose of the products.