Additional marking for medical devices
with the CE marking?
 Additional marks of quality, safety and efficiency mean additional testing (double or multiple inspections) and additional monitoring.
 Additional tests mean additional costs.
 Additional costs result in more expensive
medical devices without increased benefit.
Conclusion:
Additional marks of quality, safety and efficiency
for medical devices other than the CE marking
can be confusing and they are superfluous since
they do not demonstrate more quality than the CE
marking.
Additional marks do not promote
 better protection of health
 better performance
 improved safety for patients, users and third
parties.
Based on these facts, the CE marking legally
applied to medical devices is a symbol of quality, safety and efficiency.
On the basis of the “Guide to the Implementation
of Directives based on the New Approach and the
Global Approach” additional marks are allowed
only if they fulfil a different function from that
of the CE marking.
Art. 17 Medical Devices Directive
(93/42/EEC) and
Art. 16 IVD Directive (98/79/EC) read:
"It is prohibited to affix marks or inscriptions which are likely to mislead third parties with regard to the meaning or the
graphics of the CE marking."
Published by:
BAH
Bundesverband der
Arzneimittel-Hersteller e.V.,
Bonn
www.bah-bonn.de
BPI
Bundesverband der Pharmazeutischen Industrie e.V., Berlin
www.bpi.de
BVMed
Bundesverband
Medizintechnologie e.V., Berlin
www.bvmed.de
SPECTARIS
Deutscher Industrieverband
für optische, medizinische
und mechatronische
Technologien e.V., Köln
www.spectaris.de
VDDI
Verband der Deutschen Dental
Industrie e.V., Köln
www.vddi.de
VDGH
Verband der DiagnosticaIndustrie e.V., Frankfurt a. M.
www.vdgh.de
ZVEI
Fachverband Elektromedizinische Technik im
Zentralverband Elektrotechnikund Elektronikindustrie e.V.,
Frankfurt a. M.
www.zvei.de/medtech
For further information please contact the
associations listed above.
State: January 2004
The meaning of the
CE marking for
medical devices
Important information for
distributors and purchasers,
operators and users,
patients in Germany
What are medical devices?
The term "medical device" is defined as any instrument, apparatus, appliance, material and
pertinent software, or other article intended for
human use in the diagnosis, prevention, monitoring, treatment and alleviation of diseases or as
compensation for an injury or handicap.
The term applies to any device used for the investigation, replacement or modification of the
anatomy: Also included are physiological
processes, including contraception testing, as
well as in vitro diagnosis which may be carried
out in the laboratory or at home.
Medical devices are subject to the laws and
regulations which were enacted when the European Directives 90/385/EEC (Active Implants),
93/42/EEC (other Medical Devices) and 98/79/EC
(In-vitroDiagnostics) became national law (in
Germany: "Medizinproduktegesetz" – MPG). As a
consequence all medical devices are subject to
the strict and extensive Essential Requirements
and quality assurance measures detailed in the
relevant directives.
Compliance with these extensive legal requirements ensures a high degree of
 health protection
 performance and
 safety.
This means quality for patients, users and third
parties.
What does the CE marking on a medical
device mean?
Who is responsible for ensuring that the
CE marking lives up to its promise?
The CE marking establishes that the manufacturer’s product conforms to all applicable legal
requirements. Depending on the product’s risk
level a Notified Body must be employed. The
Notified Body's identification number accompanies the CE marking.
Manufacturer
The fulfilment of all legal specifications must be
proven in a conformity assessment procedure,
which for medical devices means:
Safety
 risks and side effects are analysed, assessed
and minimised
 biocompatibility is ensured while reducing or
eliminating risk of infection
 mechanical, electrical and electromagnetic
safety is ensured
 only validated product combinations are
allowed
 safety instructions and instructions for use are
reviewed for completeness and comprehensibility
Performance and benefit
 compliance with product characteristics and
specifications
 therapeutic or diagnostic benefit is ensured
 clinical or diagnostic evaluation of medical
devices
 measurement accuracy is ensured
Monitoring
 of the manufacturer
 of the medical device
during the entire life cycle of the product.
The person or legal entity responsible for placing
a product on the market, for fulfilling the applicable legal requirements, for surveillance of the
product in the market and for notifying the
competent authorities if incidents occur.
Who monitors that the CE marking lives
up to its promise?
Notified Bodies
Independent auditing, certification and testing
institutes for verification and monitoring of product
and quality systems.
German Particulars:
Competent Authorities
The competent authority is the entity acting on
behalf of the government of a German Federal
State to ensure that all requirements are carried
out.
ZLG and ZLS
"Zentralstelle der Länder für Gesundheitsschutz
bei Arzneimitteln und Medizinprodukten" (ZLG)
and "Zentralstelle der Länder für Sicherheitstechnik" (ZLS) are the accrediting and monitoring
competent authorities for German Notified Bodies.
BfArM and PEI
"Bundesinstitut für Arzneimittel und Medizinprodukte" and "Paul-Ehrlich-Institut" (only for specific
in-vitro-diagnostics) are responsible for the analysis and evaluation of medical device risks.