Transcript PowerPoint-presentatie

Federal Agency for Medecines and Health Products
Federal Agency for Medicines and Health Products
(FAMHP)
Medical Devices: Definition and Classification
Frédérique Meulders
Health Products Division
FAMHP/FM
28.01.2010
28.01.2010
1
Federal Agency for Medecines and Health Products
Federal Agency for Medicines and Health Products
FAMHP/FM
28012010
2
Federal Agency for Medecines and Health Products
Health Products Division
Division HP
Human Body Material
and Blood
FAMHP/FM
28012010
•Medical Devices
3
Federal Agency for Medecines and Health Products
Classification of medical devices
1. Legislation
2. Definitions
3. Placing on the market
4. Classification
5. Borderline products
FAMHP/FM
28012010
4
Federal Agency for Medecines and Health Products
1. Legislation
FAMHP/FM
28012010
5
Federal Agency for Medecines and Health Products
Legislation
•European Directive 90/385/EEC concerning implantable
active medical devices transposed in the Royal Decree dated
15th July 1997
•European Directive 93/42/EEC concerning medical devices
transposed in the Royal Decree dated 18th March 1999
•European Directive 98/79/EEC concerning in vitro diagnostic
medical devices transposed in the Royal Decree dated 14th
November 2001 (under the competence of the Scientific
Institute for Public Health)
FAMHP/FM
28012010
6
Federal Agency for Medecines and Health Products
2. Definitions
FAMHP/FM
28012010
7
Federal Agency for Medecines and Health Products
Definitions
•
« medical device » means any instrument, apparatus, appliance,
software, material or other article, whether used alone or in
combination, including the software intended by its manufacturer
to be used specifically for diagnostic and/or therapeutic purposes
and necessary for its proper application, 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
And which does not achieve its principal intended action in or on the
human body by pharmacological, immunological or metabolic
means, but which may be assisted in its function by such means
FAMHP/FM
28012010
8
Federal Agency for Medecines and Health Products
Definitions
• « active medical device » means any medical device
relying for its functioning on a source of electrical energy
or any source of power other than that directly generated
by the human body or gravity
• « active implantable medical device » means any active
medical device which is intended to be totally or partially
introduced, surgically or medically, into the human body or
by medical intervention into a natural orifice, and which is
intended to remain after the procedure
• « accessory » means an article which whilst not being a
device is intended specifically by its manufacturer to be
used together with a device to enable it to be used in
accordance with the use of the device intended by the
manufacturer of the device
FAMHP/FM
28012010
9
Federal Agency for Medecines and Health Products
Examples
•Medical devices:
Bone cements; materials for sealing, approximation or adhesion to
tissues; sutures, intrauterine devices; blood bags; wound dressings;
catheters; stents; wheelchairs; hospital beds; contact lenses;….
•Active medical devices:
Hearing aids; cryosurgery equipment; lung ventilators; blood warmers;
surgical lasers; lithotriptors; therapeutic cyclotrons; gamma cameras,…
•Active implantable medical devices:
Implantable pacemaker; implantable defibrillator; neurostimulator;
cochlear implants + related leads
•Accessories:
Contact lens care products; disinfectants specifically intended for use
with MD; lubricants specifically intended for use together with MD;…
FAMHP/FM
28012010
10
Federal Agency for Medecines and Health Products
Definitions
•« manufacturer » means the natural or legal person with
responsibility for the design, manufacture, packaging and
labelling of a device before it is placed on the market under
his own name, regardless of whether these operations are
carried out by that person himself or on this behalf by a third
party.
•« authorized representative » means any natural or legal
person established in the Community who, explicitly
designated by the manufacturer, acts and may be addressed
by authorities and bodies in the Community instead of the
manufacturer with regard to the latter’s obligation under the
Directive medical devices
FAMHP/FM
28012010
11
Federal Agency for Medecines and Health Products
Definitions
•Combination medical device / medicinal product
–Drug delivery products
• Prefilled syringes, patches for transdermal drug delivery;
implants containing medicinal products in a polymer matrix
whose primary purpose is to release the medicinal product;
intrauterine devices whose primary purpose is to release
progestogens
• Drug delivery pump, nebulizer, port systems, syringe,…
–Medical devices incorporating a medicinal substance
Catheters coated with heparin; condoms coated with
spermicide; drug eluting coronary stents,…
FAMHP/FM
28012010
12
Federal Agency for Medecines and Health Products
The medical device directive shall not apply to:
•Medicinal products covered by Directive 2001/83/EC
•Cosmetic products covered by Directive 76/768/EEC
•Human blood, blood products, plasma or blood cells of
human origin or to devices which incorporate at the time of
placing on the market such blood products plasma or cells
with the exception of devices incorporating, as an integral
part, a substance which, if used separately may be considered
to be a medicinal product constituent or a medicinal product
derived from human blood or human plasma within the
meaning of Article 1 of Directive 2001/83/EC and which is
liable to act upon the human body with action ancillary to
that of the device
FAMHP/FM
28012010
13
Federal Agency for Medecines and Health Products
The medical device directive shall not apply to:
•Transplants tissues or cells of human origin nor to products
incorporating or derived from tissues or cells of human origin
with the exception of devices incorporating, as an integral
part, a substance which, if used separately may be considered
to be a medicinal product constituent or a medicinal product
derived from human blood or human plasma within the
meaning of Article 1 of Directive 2001/83/EC and which is
liable to act upon the human body with action ancillary to
that of the device
•Transplants or tissues or cells of animal origin, unless a
device is manufactured utilizing animal tissue which is
rendered non-viable or non-viable products derived from
animal tissue
FAMHP/FM
28012010
14
Federal Agency for Medecines and Health Products
3. Placing on the market
FAMHP/FM
28012010
15
Federal Agency for Medecines and Health Products
Placing on the market
•CE marking of conformity
Except for custom-made devices and
devices intended for clinical
investigation
•Essential requirements
•Conformity assessment procedures
in order to affix the CE marking
FAMHP/FM
28012010
16
Federal Agency for Medecines and Health Products
4. Classification
FAMHP/FM
28012010
17
Federal Agency for Medecines and Health Products
Classification
•4 classes : I, IIa, IIb and III depending of the duration of use,
the invasiveness and of the criticality of the intended use
•Duration:
–Transient
–Short term
–Long term
•Invasiveness
–Body orifice
–Surgically invasive device
–Implantable device
FAMHP/FM
28012010
18
Federal Agency for Medecines and Health Products
Classification rules : Non invasive devices
FAMHP/FM
28012010
19
Federal Agency for Medecines and Health Products
Classification rules: Non invasive devices
FAMHP/FM
28012010
20
Federal Agency for Medecines and Health Products
Classification rules : Non invasive devices
Rule 1
Cervical collar, hospital bed, corrective glasses, noninvasive electrodes, conductive gels, wheelchairs,…
FAMHP/FM
28012010
21
Federal Agency for Medecines and Health Products
Classification rules : Non invasive devices
FAMHP/FM
28012010
22
Federal Agency for Medecines and Health Products
Classification rules : Non invasive devices
Rule 2
• Medical devices connected to an active medical device in
Class IIa or a higher class:
tubing intended for use with an infusion pump, antistatic
tubing for anesthesia, syringes for infusion pumps,…
• Medical devices intended for use for storing or channeling
blood or other body liquids or for storing organs, parts of
organs or body tissues:
devices intended to channel blood in transfusion, devices
intended for long term storage of biological substances
and tissues such as cornea, sperm, human embryos,…
• Class I medical devices falling under rule 2:
administration sets for infusion, spoons intended for
administering of medicines, syringes without needles
FAMHP/FM
28012010
23
Federal Agency for Medecines and Health Products
Classification rules : Non invasive devices
FAMHP/FM
28012010
24
Federal Agency for Medecines and Health Products
Classification rules : Non invasive devices
Rule 3
• Class IIb medical devices falling under rule 3:
Hemodyalizers, haemodyalisis concentrates, gradient
medium for sperm separation,…
• Class IIa medical devices falling under rule 3:
Centrifugation of blood to prepare it for transfusion,
removal of CO2 from the blood and/or adding O2,
warming or cooling the blood in an extracorporeal
circulation system,…
FAMHP/FM
28012010
25
Federal Agency for Medecines and Health Products
Classification rules : Non invasive devices
FAMHP/FM
28012010
26
Federal Agency for Medecines and Health Products
Classification rules : Non invasive devices
Rule 4
• Class I medical devices falling under rule 4
Cotton wool, wound strips, gauze dressings,…
• Class IIb medical devices falling under rule 4
Dressings for chronic extensive ulcerated wounds, for severe
decubitus wounds,…
• Class IIa medical devices falling under rule 4
Adhesives for topical use, polymer film dressings, nonmedicated impregnated gauze dressings, hydrogel
dressings,…
FAMHP/FM
28012010
27
Federal Agency for Medecines and Health Products
Classification rules: Invasive devices
FAMHP/FM
28012010
28
Federal Agency for Medecines and Health Products
Classification rules : Invasive devices
FAMHP/FM
28012010
29
Federal Agency for Medecines and Health Products
Classification rules : Invasive devices
FAMHP/FM
28012010
30
Federal Agency for Medecines and Health Products
Classification rules : Invasive devices
Rule 5
• Transient use:
Handheld mirrors used in dentistry, dental impression
material, enema devices
• Short term-use:
Contact lenses, urinary catheters
• oral cavity, ear canal and nasal cavity
Dressings for nose bleeds, dentures intended to be
removed by the patient,…
FAMHP/FM
28012010
31
Federal Agency for Medecines and Health Products
Classification rules : Invasive devices
Rule 5
•long-term use:
urethral stents,…
•Oral cavity, ear canal, nasal cavity:
orthodontic wire, fixed dental prostheses, fissure sealants,…
• intended for connection to an active medical:
tracheostomy or tracheal tubes connected to a ventilator,
powered nasal irrigators, fibre optics in endoscopes connected
to surgical lasers, suction catheters or tubes for stomach
drainage,…
FAMHP/FM
28012010
32
Federal Agency for Medecines and Health Products
Classification rules : Invasive devices
FAMHP/FM
28012010
33
Federal Agency for Medecines and Health Products
Classification rules : Invasive devices
Rule 6
• Medial devices surgically invasive for transient use:
needles used for suturing, lancets, single use scalpels,
surgical swabs, surgical gloves, heart valve occluder,…
• Control, diagnose, monitor or correct a defect of the heart
or of the central circulatory system:
cardiovascular catheters, including related guidewires and
dedicated disposable cardiovascular surgical instruments
e.g. electrophysiological catheters, electrodes for
electrophysiological diagnosis and ablation,…
• Reusable instruments:
scalpels, drill bits,…
FAMHP/FM
28012010
34
Federal Agency for Medecines and Health Products
Classification rules : Invasive devices
Rule 6
•Supply energy / ionizing radiation:
catheters containing or incorporating sealed radioisotopes,
where the radioactive isotope as such is not intended to be
released into the body, if used in the circulatory system,
excluding the central circulatory system,…
• biological effect / mainly absorbed: Class IIb
•System to administer medicines – potentially hazardous:
insulin pens
•21/03/2010: Intended specifically for use in direct contact
with the central nervous system are in Class III:
Neuroendoscopes, brain spatulas, direct stimulation
cannulas,…
FAMHP/FM
28012010
35
Federal Agency for Medecines and Health Products
Classification rules : Invasive devices
FAMHP/FM
28012010
36
Federal Agency for Medecines and Health Products
Classification rules : Invasive devices
Rule 7
• Medical devices surgically invasive for short-term use:
Clamps, infusion cannulas, skin closure devices,…
• Control, diagnose, monitor or correct a defect of the heart
or of the central circulatory system through direct contact:
Cardiovascular catheters, Carotid artery shunts,…
• For use in direct contact with the central nervous system:
Neurological catheters, cortical electrodes,…
FAMHP/FM
28012010
37
Federal Agency for Medecines and Health Products
Classification rules : Invasive devices
Rule 7
• Supply energy /ionizing radiation
Brachytherapy devices,…
•Biological effect /mainly absorbed
Absorbable sutures,…
•Undergo chemical change in the body /administer medicines
(not in teeth)
Adhesives
FAMHP/FM
28012010
38
Federal Agency for Medecines and Health Products
Classification rules : Invasive devices
FAMHP/FM
28012010
39
Federal Agency for Medecines and Health Products
Classification rules : Invasive devices
Rule 8
• Implantable devices / long-term surgically invasive
devices:
Stents, intra-ocular lenses, infusion ports,…
• To be placed in teeth:
Bridges, crowns,…
• Used in direct contact with heart or central circulatory
system or the central nervous system:
Prosthetic heart valves, aneurysm clips, CNS electrodes,…
FAMHP/FM
28012010
40
Federal Agency for Medecines and Health Products
Classification rules : Invasive devices
Rule 8
• Biological effect or mainly absorbed:
Absorbable sutures,…
•Undergo chemical change in the body or administer medicines
(not in teeth)
Rechargeable non-active drug delivery systems,…
•Directive 2003/12/EC: Breast implants are in Class III
•Directive 2005/50/EC: total hip, knee and shoulder joint
replacement implants are in Class III
FAMHP/FM
28012010
41
Federal Agency for Medecines and Health Products
Classification rules: Active devices
FAMHP/FM
28012010
42
Federal Agency for Medecines and Health Products
Classification rules : Active devices
FAMHP/FM
28012010
43
Federal Agency for Medecines and Health Products
Classification rules : Active devices
Rule 9
• Active therapeutic devices intended to administer or
exchange energy
External bone growth stimulators, cryosurgery equipment,
hearing aids,…
• Administer or exchange energy in a potentially hazardous
way
Lung ventilators, incubators for babies, external defibrillator,
linear accelerators,…
• Intended to control & monitor or influence directly a class
IIb active therapeutic device
External feedback systems for active therapeutic devices,…
FAMHP/FM
28012010
44
Federal Agency for Medecines and Health Products
Classification rules : Active devices
FAMHP/FM
28012010
45
Federal Agency for Medecines and Health Products
Classification rules : Active devices
Rule 10
Active devices intended for diagnosis are in Class IIa:
• If they are intended to supply energy which will be absorbed by
the human body, except for devices used to illuminate the
patient’s body, in the visible spectrum,
Ex: Magnetic resonance equipment, evoked response stimulators,…
• If they are intended to image in vivo distribution of
radiopharmaceuticals,
Ex: Gamma cameras, positron emission tomography,…
FAMHP/FM
28012010
46
Federal Agency for Medecines and Health Products
Classification rules : Active devices
Active devices intended for diagnosis are in Class IIa:
•If they are intended to allow direct diagnosis or monitoring of vital
physiological processes,
Ex: electrocardiographs, electronic thermometers,…
unless they are specifically intended for monitoring of vital
physiological parameters, where the nature of variations is such that it
could result in immediate danger to the patient, for instance variations
in cardiac performance, respiration activity of CNS in which case they
are in Class IIb.
Ex: intensive care monitoring and alarm devices , apnea monitors,…
Active devices intended to emit inonizing radiation and intended for
diagnostic and therapeutic interventional radiology including devices
which control or monitor such devices, or which directly influence their
performance, are in Class IIb.
Ex: Diagnostic X-ray sources
FAMHP/FM
28012010
47
Federal Agency for Medecines and Health Products
Classification rules : Active devices
FAMHP/FM
28012010
48
Federal Agency for Medecines and Health Products
Classification rules : Active devices
Rule 11
• Active devices to administer and/or remove medicines &
other substances to or from the body
Feeding pumps, jet injectors for vaccination,…
• If this is in a potentially hazardous way
Infusion pumps, ventilators, anesthesia machines, hyperbaric
chambers,…
FAMHP/FM
28012010
49
Federal Agency for Medecines and Health Products
Classification rules : Active devices
FAMHP/FM
28012010
50
Federal Agency for Medecines and Health Products
Classification rules : Active devices
Rule 12
All other active devices are in Class I.
Examination lights, hospital beds, wheelchairs, active
diagnostic devices intended for thermography,…
FAMHP/FM
28012010
51
Federal Agency for Medecines and Health Products
Classification rules: Special rules
FAMHP/FM
28012010
52
Federal Agency for Medecines and Health Products
Classification rules : Special rules
FAMHP/FM
28012010
53
Federal Agency for Medecines and Health Products
Classification rules : Special rules
Rule 13
• Devices incorporating integral medicinal product liable to
act in ancillary way on human
Antibiotic bone cements, condoms with spermicide, heparin
coated catheters, dressings incorporating an antimicrobial
agent where the purpose of such an agent is to provide
ancillary action to the wound,…
• All devices incorporating, as an integral part, a human
blood derivative are in Class III
Surgical sealants containing human serum albumin
FAMHP/FM
28012010
54
Federal Agency for Medecines and Health Products
Classification rules : Special rules
FAMHP/FM
28012010
55
Federal Agency for Medecines and Health Products
Classification rules : Special rules
Rule 14
• Devices used for contraception or prevention of sexually
transmitted diseases
Condoms, contraceptive diaphragms,…
• If implantable or long term invasive
Contraceptive intrauterine devices
FAMHP/FM
28012010
56
Federal Agency for Medecines and Health Products
Classification rules : Special rules
FAMHP/FM
28012010
57
Federal Agency for Medecines and Health Products
Classification rules : Special rules
Rule 15
• Specific for disinfecting, cleaning, rinsing devices for contact
lenses
Contact lens solutions, comfort solutions
•
For disinfecting other medical devices other than by physical
action Unless they are specifically to be used for disinfecting
invasive devices in which case they are in Class IIb.
Disinfectants specifically intended for instance for non-invasive
medical device
•
21/03/2010: Unless they are specifically to be used for
disinfecting invasive devices in which case they are in Class IIb.
Disinfectants, washers or sterilizers for endoscopes, for surgical
equipment…
FAMHP/FM
28012010
58
Federal Agency for Medecines and Health Products
Classification rules : Special rules
FAMHP/FM
28012010
59
Federal Agency for Medecines and Health Products
Classification rules : Special rules
Rule 16
• Devices specifically intended for recording of X-ray
diagnostic images.
X-ray films, photostimulable phosphor plates,…
FAMHP/FM
28012010
60
Federal Agency for Medecines and Health Products
Classification rules : Special rules
FAMHP/FM
28012010
61
Federal Agency for Medecines and Health Products
Classification rules : Special rules
Rule 17
• Devices utilizing animal tissues or derivatives (not devices
in contact only with intact skin)
Biological heart valves, porcine xenograft dressings,
implants and dressings made from collagen,…
FAMHP/FM
28012010
62
Federal Agency for Medecines and Health Products
Classification rules : Special rules
FAMHP/FM
28012010
63
Federal Agency for Medecines and Health Products
Classification rules : Special rules
Rule 18
Blood bags
FAMHP/FM
28012010
64
Federal Agency for Medecines and Health Products
5. Borderline Products
FAMHP/FM
28012010
65
Federal Agency for Medecines and Health Products
Borderline products
Borderline medical device / medicinal product
Article 2(2) of directive 2001/83/EC:
In case of doubt, where, taking into account all its
characteristics, a product may fall within the definition od a
« medicinal product » and within the definition of a product
covered by other Community legislation the provisions of this
Directive shall apply
FAMHP/FM
28012010
66
Federal Agency for Medecines and Health Products
Borderline products
•Elastoviscous fluids
–Case by case analysis
•Peritoneal dialysis solutions
–Not a medical device
FAMHP/FM
28012010
67
Federal Agency for Medecines and Health Products
Borderline products
• Eye drops intended for /related to the alleviation of
« soreness », « discomfort », or « irritation » caused by
environmental factors
– Case by case analysis
• Zinc oxide containing creams
– Case by case analysis
FAMHP/FM
28012010
68
Federal Agency for Medecines and Health Products
Borderline products
Borderline medical device / biocides
• Hand disinfectants
– Not a medical device
FAMHP/FM
28012010
69
Federal Agency for Medecines and Health Products
Links
•FAMHP website: http://www.fagg-afmps.be
•Email: [email protected] / [email protected]
•European Commission Medical Devices:
http://ec.europa.eu/enterprise/sectors/medicaldevices/index_en.htm
FAMHP/FM
28012010
70
Federal Agency for Medecines and Health Products
Thank you for your attention
FAMHP/FM
28012010
71