It can be recognized in the worldwide development of regulatory requirements for medical devices as well as for many other products that the introduction of quality systems is more and more requested. It is no secret that a suitable quality system, which is implemented in all relevant stages may be an important factor for maintaining and improving product safety and performance.

For whatever reasons, a lot of manufacturers persistently believe that a quality management system according to ISO 9001 is the key to CE-marking. This is simply wrong. The ISO 9000 series of standards is the most popular way for the proper organization of a quality management system. And EN 46003 in combination with the guidance standards EN 724 or EN 50103 -which all include ISO 9001 - are harmonized European standards. But harmonized standards are not the only way to demonstrate compliance with the MDD (see next chapter).

The MDD requires that the manufacturer of medical devices keeps a product-related, adequate and efficacious quality system. The application of the quality system must ensure that the products conform to the provisions of the MDD. All the elements, requirements and provisions adopted by the manufacturer for his quality system must be documented in a systematic and orderly manner in the form of written policies and procedures such as quality programs, quality plans, quality manuals and quality records.

The MDD gives more flexibility to the device manufacturer in organizing his company according to size, social environment, culture of countries, and nature of the devices than the ISO 9000 series of standards. On the other hand even ISO 9001 in combination with the additional requirements of EN 46003, under consideration of EN 724 or EN 50103, does not fully cover the requirements of the MDD.

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Additional aspects to be covered by the quality management system include:

• the technical documentation
• reference to the essential requirements according to Annex I of the MDD
• information about harmonized standards and medical device regulations
• risk analysis
• labeling and instruction
• different languages
• post-marketing surveillance
• reporting under the vigilance system
• retention of certain documents

It is the task of the Notified Body to understand the culture of the manufacturer and to evaluate whether or not the quality management system meets the minimum requirements of the MDD, and to give advice where deficiencies are detected.