Regulatory Information

Standardisation in the EU is being implemented throughout Europe as the borders between Member States are eliminated and the principle of free movement of goods within the Union is on the uptake.  A 'New Approach' to standardisation was implemented in 1985 to facilitate these changing attitudes.  New legislative requirements for health and safety were put into practice along with the harmonised European standards.

The 'New Approach' directives cover a broad range of products from hot water boilers to toys.  The following directives are Of particular interest to the medical device market:

The Active Implantable Medical Device (ARWD) Directive - 901385/EF-C
The Medical Device Directive (MDD) - 93142/EEC
The In Vitro Diagnostic Device Directive (WD) - 98179/EC.

There are well over 150 harmonised standards relating to these directives and conformance with them is the easiest way to show compliance with the directives. Compliance with the directives is mandatory, while conformance with the harmonised standards is not. Where conflicts between a medical directive and a European national law arise the directive takes precedence.

Having said that, harmonised standards are not the only way to demonstrate compliance with the MDD.

The MDD requires the manufacturer of medical devices to keep 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 NMD. All the elements, requirements and provisions adopted by the manufacturer for the 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 organising the company according to size, social environment, and cultural trends of countries as well as the nature of the devices than the ISO 9000 series of standards. On the other hand even ISO 9001 registration in combination with the additional requirements of EN 46001 does not fully cover the requirements of the MDD.

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