Bureau Veritas Services
CE MARKING OF MEDICAL DEVICES
Directive 93/42/EEC and ISO 13485 Certification Requirements
SCENARIO
Manufacturers of Medical Devices are subject to specific legislative fulfillments. Medical Devices intended for
diagnostic or therapeutic use, must comply with stringent requirements for safety and effectiveness.
In particular, the European Directive 93/42/EEC, implemented in EU Members by national Legislations, requires
CE Marking for Medical Devices to sell them on European Union market.
Medical Device is any instrument, apparatus, appliance, software, substance or other article whether used alone
or in combination, including the software needed for use, intended by the Manufacturer to be used for human
beings for the purpose of:
 diagnosis, prevention, monitoring, treatment or alleviation of disease
 diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
 investigation, replacement or modification of the anatomy or of a physiological process
 control of conception
The peculiarity of Medical Devices is that they do not achieve their main intended action in or on the human
body by pharmacological, immunological or metabolic means, but they may be assisted in their function by such
ways. For all these devices CE Marking is mandatory by law.
SOLUTION
What is CE Marking?
CE Marking consists on a mark, placed on the product by the Manufacturer, certifying that it complies with the
essential requirements of the applicable EU Directives.
In the case of Medical Devices, it comes to safety and efficacy requirement that both devices and their
production system must have.
ISO 13485:2012 Medical Devices-Quality Management Systems - Requirements for regulatory purpose
standard is harmonized to Directive 93/42/EEC, which specifies the requirements for the Quality Management
System of Organizations that produce Medical Devices and aims to demonstrate that the Medical Devices and
related services are complying with the legal requirements and the final customer needs.
CE Marking path requires a number of customer tasks and a Notified Body intervention to define the risk
classes.
What are main advantages of the CE Marking?
 CE Mark allows the access to the EU market
 The process of CE Marking al lows manufacturers to know the requirements to be respected and
demonstrate the conformity of their products.
Bureau Veritas is an inspection Body, notified by the National Health Authority, to perform certification services
required for CE Marking of Medical Devices.
WHY CHOOSE BUREAU VERITAS?
 CE Authorization and Accreditation: Bureau Veritas is authorized by the National Health Authority to act as
Notified Body for Medical Devices CE Marking in accordance with Directive 93/42/EEC. Bureau Veritas is
accredited for certification activities in accordance with ISO 13485:2012 Medical Devices-Quality Management
Systems standard.
 Experience: Bureau Veritas has created, in its matrix structure, a business unit dedicated to the Biomedical
and Health Care Sector and has specific skills and knowledge about this sector. Bureau Veritas also operates
nationally and internationally in the sector of CE Marking, with notifications that cover a wide range of industrial
products and EU Directives. Bureau Veritas is able to propose itself as one-stop partner for ISO Certification and
CE Marking.
 Network: Bureau Veritas provides to the customer the experience of an international Group with more than
1’300 locations in 140 countries and over 64’000 skilled employees.
CE MARKING PATH
OUR SERVICE
In order to obtain from the National Health Authority the
authorization to sell the product on European market,
Manufacturers shall demonstrate the conformity of Medical
Devices and the related production system.
 The classification of the device is the first step that
Manufacturers must car ry on in order to identify the type
of risk and adopt the resulting marking procedures.
Medical Devices are classified into:
- Class I - Class IIa - Class IIb - Class III
Some Medical Devices follow specific classifications:
- Class I sterile
- Class I with measuring function
- Custom-made devices
- Devices intended for clinical investigations
- Systems and kits for the operating field
 Then Manufacturers prepare the Technical Dossier:
a document showing design, results of the risk analysis,
applied technical standards, test reports, clinical
evaluation, draft label and instructions for use.
 To complete the path of conformity, Manufacturers
award a Notified Body. The intervention of the
Notified Body is required for all Risk Classes except for
Class I, which presents limited complexity and risk to the
patient.
Bureau Veritas offers a CE Marking service in two distinct
phases:
- Evaluation of the Technical Dossier: verification of
completeness and compliance with the essential
requirements
- Ve ification of the Quality Management System of
against ISO 13485
 At the end of this path, Manufacturers produce a
Declaration of Conformity and place the CE Mark on
the product.
FAQ
Bureau Veritas is a Notified Body by National Health
Authority (for the CE Marking) in accordance with
Annexes II, V, VI of the Directive for Medical Devices of
the types listed below and the classes of r isk I sterile, I
with measuring function, IIa and IIb:
NON ACTIVE MEDICAL DEVICES
General non-active, non- implantable Medical Devices
 Non-active devices for anesthesia, emergency and
intensive care
 Non-active devices for injection, infusion, transfusion and
dialysis
 Non-active orthopedic and rehabilitation devices
 Non-active medical devices with measuring function
 Non-active ophthalmologic devices
 Non-active instruments
 Non-active medical devices for disinfecting, cleaning, rinsing
Medical devices for wound care
 Bandages and wound dressings
 Suture material and clamps
 Other medical devices for wound care
Non-active dental devices and accessories
 Non-active dental devices/equipment and instruments
 Dental materials
 Dental implants
ACTIVE MEDICAL DEVICES
(Non- Implantable) General active Medical Devices
 Respiratory devices, devices including hyperbaric
chambers for oxygen therapy, inhalation anesthesia
 Devices for stimulation or inhibition
 Active surgical devices
 Active ophthalmologic devices
 Active dental devices
 Active devices for disinfection and sterilisation
 Active rehabilitation devices and active prostheses
 Software
Devices for imaging
 Devices utilizing ionizing rays
Monitoring devices
 Monitoring devices of non-vital physiological parameters
 Monitoring devices of vital physiological parameters
Devices for radiation therapy and thermo therapy
 Devices for hyperthermia / hypothermia
Particular medical devices active and inactive
 Medical devices with reference to Directive 2006/42/EC on
machinery (Legislative Decree 27 January 2010, n. 17)
 Medical devices in sterile package
CONTACT
 Bureau Veritas Certification (Schweiz) AG
Grossächerstrasse 25, 8104 Weiningen
 Tel.: +41 44 752 11 55, Fax.: +41 44 752 11 99
 Email: info@ch.bureauveritas.com
FOR MORE INFORMATION
Please visit us:
www.bureauveritas.ch
FS 030614 CEMARKING_EN– pdf.
What criter ia must the Manufacturer follow for the Risk
Classification of Medical Devices he is producing?
Medical Devices are classified according to their
complexity. The Risk Class depends on the device
complexity and risk for the patient.
The classification criteria of the Medical Devices depend
on:
 Duration of contact with the patient (temporary, short/
long term)
 Invasive (non- invasive devices, invasive, invasive
surgical implants)
 Operation mode (device not active, devices active
therapeutic and diagnostic)
 Anatomical site on which is effecting the device (in
particular central circulatory system and nervous central system).