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Author: Joachim Wasner, Dräger Medical ANSY GmbH

The European Medical Device Directive ([MDD]) requires medical devices to bear a corresponding CE label before they are released for sale and brought into any country belonging to the European Union. Medical devices with a risk class higher than 1 are subject to a conformity assessment procedure (MDD Article 11) before receiving CE-certification. The technical documentation and the risk management procedures performed are evaluated there. This requirement is intended to ensure that the basic requirements [Annex I of EC Directive 93/42/EEC] for medical devices are fulfilled.

Conformity assessment procedure
Supply systems for medical gases are Class IIb medical devices and are always subject to a conformity assessment procedure. The declaration of conformity is the "result" of the conformity assessment procedure with which the legally liable manufacturer certifies the conformity to the directives stated - and therefore the fulfillment of the basic requirements stated in Annex I of the EC directive 93/42/EEC.

The conformity assessment procedure comprises two sections:

• Proof of technical conformity of the product with the "general" basic requirements, for example through verification with the harmonized standards (e.g. EN 737-3 by placing the corresponding documentation in the technical documentation) and
• Fulfillment of the quality assurance requirements for the product

for example through certification of the quality management system of the manufacturer by a designated certifying body with the results of the EC certification procedure according to Annex II of EC directive 93/42/EEC.

Manufacturers of supply systems for medical gases without EC certification may only manufacture these systems and place them on the market with the help of a designated certifying body (according to Annex III, IV, V or VI of the directive).
or
they are operating facilities of a manufacturer with EC certification. In this case the operating facility works strictly according to the rules of the quality management system of the EC certificate holder. The holder of the EC certificate is therefore the legally liable manufacturer of the installed system and writes the declaration of conformity.
In Germany, §§40–43 of the medical product laws (punishment and fine regulations) apply when the legal requirements are not met.

Writing the offer, project planning and installation
The installation of the supply systems for medical gases is a major step in production and is to be performed by employees of the manufacturer or of its authorized operating facilities at the system's installation site. The manufacturer, and not its operating facilities, are responsible for the know-how involved and for the completion of a conformity assessment procedure. The manufacturer must prescribe specific rules (processes in the quality management system) that the operating facilities must strictly abide to when writing the offer, planning the project and installing the system. Only components released for use may be used in this process. If the customer wants components that deviate from this standard, for example a compressor from a different manufacturer, then the corresponding risk analysis must be extended to include these special components.

Risk management
The installed supply systems for the medical gases including all individual components such as the oxygen supply, compressed air compressors with compressed air drying systems, pressure reduction stations, pipe systems, etc., are to be evaluated as medical devices. DIN EN ISO 14971 (Medical Devices - Application of Risk Management to Medical Devices) suggests the use of the FMEA (Failure Mode and Effect Analysis) methodology, among others.

Risk analysis using the FMEA method
To prevent potential failures in products and processes, the system elements and function structures are evaluated as a preventative measure. The method allows for systematic detection of potential weak spots and determination of their causes and their effects on the overall system. The goal of this task is to prevent failures early on in the Engineering or Development departments during the product design phase. The weak spots detected are eliminated early by taking suitable action. A matrix analysis is performed before the FMEA to systematically name all relevant system elements so that no important system elements are missed. The documented FMEA serves as proof that the basic requirements for medical devices are fulfilled (see Annex I of EC Directive 93/42/EEC).

FMEA Software
Through the use of suitable FMEA software (SCIO from Plato), risk management is simplified and the amount of time spent on risk management is significantly reduced. The extension of the risk assessment to include special components deviating from the standard can be performed quickly. Any system components not suitable for use as part of a supply system for medical gases are detected early and designated as not approved for use with these methods. The customer is informed that it is not approved with the corresponding justification and also receives a suggestion for an approved alternative.

Manufacturers of medical gas supply systems
The Dräger Medical ANSY GmbH designs, develops, and manufactures supply systems for medical gases. The company is certified (EC certification) in accordance with Annex II of directive 93/42/EEC and is therefore authorized to perform the mandatory conformity assessment procedure without involving a certifying body.