Artificial

Organs

MEDICAL DEVICES REGULATIONS

and CLASSIFICATIONS

Yrd.Doç.Dr. Ozan Karaman

ozan.karaman@ikc.edu.tr

1
 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

2
 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

3
 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;…

4
 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

5
 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,…

6
Placing on the market

7
 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

• CE Marking is the symbol as shown on the top of this page. The letters "CE" are the
abbreviation of French phrase "Conformité Européene" which literally means
"European Conformity". The term initially used was "EC Mark" and it was officially
replaced by "CE Marking" in the Directive 93/68/EEC in 1993. "CE Marking" is now
used in all EU official documents.
• CE Marking on a product is a manufacturer's declaration that the product complies
with the essential requirements of the relevant European health, safety and
environmental protection legislation 8
Classification

9
 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
10
11
12
Medical Device Stakeholders

13
 Regulatory Provisions
• The Regulations apply to:
– The sale and advertising for sale of a medical device
– The importation of a medical device for sale or for use on
individuals, other than importation for personal use
• Manufacturers of medical devices apply to receive either a
Licence or an Authorization to sell their devices.

14
 Regulatory Provisions
A manufacturer:
– Sells a medical device under their own name, trade-mark,
design, trade name or other name owned or controlled by
the person
– Is responsible for designing, manufacturing, assembling,
processing, labelling, packaging, refurbishing or modifying
the device, assigning it a purpose
– Performs or has someone perform on their behalf

Manufacturer = Name on the label

15
 Classification of Medical Devices
• Medical Devices Regulations (MDR) sets out a
system for classifying medical devices into one
of four classes.

Class IIa Class IIb Class III

Class I
Low Risk Moderate Risk High Risk

Increasing Regulatory Oversight

16
 Risk-Based Regulatory System
Class III
- Certification that device is designed & manufactured according
to ISO 13485
Premarket regulatory oversight - Evidence of safety, effectiveness & labelling reviewed to validate
based on licensing system. compliance with MDR. More stringent review than Class III.
Market authorization is granted to
manufacturers who demonstrate 4 Class IIb
conformity to requirements set out - Certification that device is designed & manufactured according
in MDR. to ISO 13485
Post-market surveillance intended - Evidence of safety, effectiveness & labelling reviewed to
validate compliance with MDR.
to enforce and promote compliance
with MDR
3
Class IIa
- Certification that device is manufactured according
to international Quality Management System
standard (ISO 13485).
2 - Manufacturer’s attestation that device satisfies the
Premarket oversight with safety, effectiveness requirements in MDR. Label
establishment licensing reviewed.
Post-market surveillance to
Class I
promote compliance with
- Premarket regulatory oversight based on
MDR
establishment licensing
1 - Post-market oversight based on
compliance to applicable sections of the
MDR

17
 Quality Management System
• ISO 13485:2003 Quality Management System
Certificate
• Recognized Registrars:

BSI (US) Dekra (Netherlands)

Intertek (CN) G-MED (France)
LRQA (US) NSAI (Ireland)
SGS (UK) SAI (Australia)
DQS (GER) LGA (GER)
TUV-N/S (US) TGA (Australia)
UL (USA) TUV (US)
TSE Turkey 18
Application Process – Class II

19
Application Process – Class IIb & III

20
 REQUIREMENTS Class I Class IIa Class IIb Class III

Medical Device Licence (s.26) exempt

must hold active must hold active must hold active
(manufacturer) licence licence licence

keep objective
Safety & Effectiveness (s. 10-20) keep objective
evidence & provide
submit objective submit objective
(manufacturer) evidence evidence for review evidence for review
attestation

Labelling (s. 21-23) compliant label compliant label compliant label

(all parties engaged in importation or sales compliant label
(submit for review) (submit for review) (submit review)
activities)

Quality Management System ISO 13485 certified ISO 13485 certified ISO 13485 certified
Certificate exempt (for manufacturing (for design and (for design and
(manufacturer) activities) manufacturing activities) manufacturing activities)

Distribution Records (s. 52-56) maintain record maintain record maintain record maintain record
(manufacturer, importer & distributor)

Complaint Handling (s. 57-58) maintain record maintain record maintain record maintain record
(manufacturer, importer & distributor)

Mandatory Problem Reporting (s. 57-

submit preliminary & submit preliminary & submit preliminary & submit preliminary &
61) final report final report final report final report
(manufacturer & importer)

Recall (s. 63-65) submit recall notice submit recall notice submit recall notice submit recall notice
(manufacturer & importer)

must hold active must hold active must hold active

Establishment Licence (s. 44) must hold active licence (to licence licence
(class I manufacturer, importer & distributor) licence import/distribute other (to import/distribute other (to import/distribute other
manufacturers’ devices) manufacturers’ devices) manufacturers’ devices)
 Classification of Medical Devices
• To determine the classification of a device, you must apply all of the
rules in Schedule 1 of the Medical Devices Regulations.

• You must consider the labelled indications for use, or claims made for
the device.

22
 Classification of Medical Devices
• Non In vitro Diagnostic Devices
– Large number of variables
– Rapid technological advances
– Classification criteria based on:
• The human body
• Inherent device related potential hazards
• Customary device use (O.R., I.C.U., N.I.C.U.)

23
 Definitions
• “Invasive device” means a medical device
that is intended to come into contact with the
surface of the eye or penetrate the body,
either through a body orifice or through the
body surface.

• “Surgically invasive device” means an invasive

device that is intended to enter the body
through an artificially created opening that
provides access to body structures and fluids.

24
 Definitions
• “Central cardiovascular system” means the heart,
pericardium, pulmonary veins, pulmonary arteries, cardiac
veins, coronary arteries, common carotid arteries, cerebral
arteries, common carotid arteries, cerebral arteries,
brachiocephalic artery, aorta, inferior and superior vena cava,
renal arteries, iliac arteries and femoral arteries.

• “Surgical or dental instrument” means a reusable medical

device that is intended for surgical or dental use, including
cutting, drilling, sawing, scraping, clamping, hammering,
puncturing, dilating, retracting or clipping, without connection
to an active device.

25
 Definitions
• “Active Diagnostic Device” means an active device that,
whether used alone or in combination with another medical
device, is intended to supply information for the purpose of
detecting, monitoring or treating a physiological condition,
state of health, illness or congenital deformity.

• “Active Therapeutic Device” means an active device that,

whether used alone or in combination with another medical
device, is intended to support, modify, replace or restore a
biological function or structure for the purpose of treating or
mitigating an illness or injury or a symptom of an illness or
injury.

26
 Classification of Medical Devices
• In vitro Diagnostic Devices (IVDDs)
– IVDD means a medical device that is intended to be used
in vitro for the examination of specimens taken from the
body.

– The greater the risk associated with a false positive/false

negative, the higher the Class.

27
 Definitions
• “Near patient IVDD” means an in vitro diagnostic device that
is intended for use outside a laboratory, for testing at home or
at the point of care, such as a pharmacy, a health care
professional’s office or the bedside.

28
29
30
 Classification?
• Antimicrobial Wound • Bandage
Dressing

31
 Classification?
• X-Ray Computed • Portable X-Ray Machine
Tomography Scanner

32
 Classification?
• Natural Absorbable Suture

33
 Classification?
• Oral Thermometer

34
 Classification?
• Drugs of Abuse Test Cassette • Drugs of Abuse Test Cup
(For laboratory use only) (For point of care use)

35
 Classification?
• Pregnancy Test

36
 Overview
• Class I (low risk) – Class IV (high risk)
• Pre-market resources apply primarily to Class III & IV
• Product licensing applies to Class II, III & IV
• Quality Management System requirements apply to Class II, III
& IV
• Post-market requirements apply to all classes

37
Interesting Statistics

38
Medical Devices in Turkey

39
40
41
42
43
44
 Final Project
• Imaging that you are founding a biotechnology company
Ø Finance-Tubitak or Kosgeb, which project call?
Ø Company name and brand name
Ø Developing solid product-Artificial organ, tissue, treatment device, testing
device etc.
Ø Design parameters-Critically consider clinical evaluation report? Need
clinical study? Your time frame to have the product in the market?
Ø Novel design or partialy similar, Give details, defend your product
Ø Why does your product will be good alternative to the ones in the market
Ø What is the classification of your device?
Ø What sort of biocompatability tests you need to complete? Where are you
planning to complete?
Ø What is the market value? How much approxiamately your design will cost?
Ø What sort of fabrication environment you require-what type of clean room
etc.
Ø Where are you planning to sell your product? CE or FDA- regulations?

45
 Final Project
• 18.12.2017 Final Project-Presentations start at
9:00 am
• Each group will have 20-25 minutes and 5-10
minutes discussion
• Watch out timing!
• All group members need to have knowledge
about whole presentation.
• Make sure you work with whole group.
• Order of the presentations-Group 1,2,3,4,5, and
6.
46