Useful information for   .

·      distributors

·      purchasers

·   .  operators

·      users

·      patients

What are medical devices?

The term "medical device" is defined as any instrument, apparatus, appliance, material, software pertinent to it or other article intended to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment, alleviation of disease or compensation for an injury or handicap.

It also applies to any device used for the investigation, replacement or modification of the anatomy or of a physiological process as well as for the control of conception.

Prerequisite for these devices is that their principal intended action in or on the human body is achieved in a physical manner (as defined in the European Directives 93/42/EEC and 90/385/EEC).

Medical devices are subject to the laws and regulations with which the European   Directives 93/42/EEC and 90/385/EEC were implemented into national law. As a consequence medical devices have to comply with the strict and complex Essential Requirements specified in the above Directives.

Compliance with these comprehensive legal requirements ensures a high degree of

·       health protection

·       performance

·       safety

for patients, users and other persons.

With the CE marking the manufacturer shows that his product satisfies the Essential Requirements applicable to it. Depending on the classification of the product the CE marking must be accompanied by the identification number of the Notified Body.

What does the CE marking on a medical device mean?

Medical devices must have been manufactured in conformity with the Essential Requirements specified in the Directives applicable to it and with the national law. This procedure referred to as conformity assessment procedure comprises among other things for any medical device:

Safety

·       analysing and assessing risks

·       minimising side effects

·       ensuring biocompatibility

·       ensuring electrical and mechanical safety

·       allowing or forbidding product combinations

·       checking safety instructions and instructions for use for completeness and comprehensibility

Performance and benefit

·       compliance with specified product properties

·       ensuring therapeutic benefit

·       preventing infections and contaminations

·       clinical assessment of medical devices

·       ensuring measuring accuracy

Surveillance

·       of the manufacturer

·       of the medical device

during the entire life cycle of a product.

Who is responsible for ensuring that the CE marking lives up to its promise?

·       Manufacturer

The natural or legal person responsible for placing a product on the market, for fulfilling the relevant legal requirements, and for notifying the Competent Authorities of the Member States where incidents occur.

·       Notified Bodies

Independent auditing, certification and testing institutes for verification of product and quality systems as well as monitoring thereof.

Additional marks for medical devices with CE marking?

·       Other marks mean additional tests (double or multiple inspections) and additional monitoring.

·       Additional tests also mean additional costs.

·       Additional  costs mean only more expensive medical devices - but do not increase their benefits

Conclusion:

Additional marks on medical devices bearing the CE marking are unnecessary.

They do

·       not lead to better protection,

·       not lead to better performance,

·       not lead to higher safety for patients, users and other persons.

Based on these facts, the C mark which is legally put on medical devices is de facto a quality mark.