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
2. Infection and microbial contamination
2.1. The devices and their manufacturing processes must be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the user or other persons. The design must allow easy handling and, where necessary, reduce as far as possible contamination of, and leakage from, the device during use and, in the case of specimen receptacles, the risk of contamination of the specimen. The manufacturing processes must be appropriate for these purposes.
2.2 Where a device incorporates biological substances, the risks of infection must be reduced as far as possible by selecting appropriate donors and appropriate substances and by using appropriate, validated inactivation, conservation, test and control procedures.
2.3. Devices labelled either as ‘STERILE’ or as having a special microbiological state must be designed, manufactured and packed in an appropriate pack, according to procedures suitable for ensuring that they remain in the appropriate microbiological state indicated on the label when placed on the market, under the storage and transport conditions specified by the manufacturer, until the protective packaging is damaged or opened.
2.4. Devices labelled either as ‘STERILE’ or as having a special microbiological state must have been processed by an appropriate, validated method.
2.5. Packaging systems for devices other than those referred to in section 2.3 must keep the product without deterioration at the level of cleanliness indicated by the manufacturer and, if the devices are to be sterilised prior to use, reduce as far as possible the risk of microbial contamination.
Steps must be taken to reduce as far as possible microbial contamination during selection and handling of raw materials, manufacture, storage and distribution where the performance of the device can be adversely affected by such contamination.
2.6. Devices intended to be sterilised must be manufactured in appropriately controlled (e.g. environmental) conditions.
2.7. Packaging systems for non-sterile devices must keep the product without deterioration at the level of cleanliness stipulated and, if the devices are to be sterilised prior to use, minimise the risk of microbial contamination; the packaging system must be suitable taking account of the method of sterilisation indicated by the manufacturer.