Electronic medical equipment.
Medical Engineering
medical facilities Medical Apparatus Medical instrument
By type use energy
electromedical Mechanical
apparatus electromedical apparatus
by direction energy flow
Have action devices Perceptive devices
Perceptive devices
By type energy, perceptive
light energy chemical energy
heat energy electrical energy Mechanical energy
Have action devices
by function
therapeutic diagnostical
By type influence
electrical mechanical
energy energy
X-ray low frequency
gas hydraulic
light - optical ultra sound
mechanical
high frequency
Electromagnetic Energy
is bidirectional
Exchange
Frequencies
electromedical apparatus
• sensor,
• converter,
• Output device
• Power sappy
Heinz-Eckhard Schmittendorf
Safety and Regulatory Affairs
1. Introduction
2. The Medical Devices Directive
3. Conformity Assessment Procedure
4. Exercise and Discussion
Siemens AXIOM Artis BA
Safety and Regulatory Affairs / Introduction
What is the intended use of the device?
•
•
What potential risks do you see?
•
•
Assess these risks. Are they acceptable?
•
•
What can the manufacturer do
to reduce these risks?
•
•
How can the manufacturer prove
that safety of the device is sufficient?
•
•
Safety and Regulatory Affairs / Introduction
- Risk Analysis According to EN 1441 -
identify characteristics & intended use
identify possible hazards
estimate risk for each hazard
yes
risk acceptable?
reduce risk
re-design
yes
remaining risk acceptable?
risk analysis report / review
Safety and Regulatory Affairs / Introduction
- Risk Analysis According to EN 1441 -
Failure Mode and Effect Analysis (FMEA)
fault mode S P D R safety means S P D R ok?
power outage 8 1 10 80 emergency power 1 1 10 10 ok
(device stops) system
contact with hot wire 8 4 4 128 application of 8 1 4 32 ok
(electrical shock) standard EN 60601-1
S - severity of consequences (1..10)
P - probability of occurrence (1..10)
D - detectability (1..10)
R - risk = S x P x D (1..1000), threshold of acceptability = 50
Safety and Regulatory Affairs / Introduction
- Summary -
The use of medical devices involves specific risks
It is the manufacturer's responsability to
- identify potential risks,
- evaluate the acceptability
- reduce risks to an acceptable level
The application of standards helps
to ensure a high level of safety
Documentation is necessary to demonstate
appropriate risk management
Safety and Regulatory Affairs
2.
The Medical Devices Directive
Siemens AXIOM Artis BA
Medical Devices Directive
- The „New Approach“ -
In 1985 the European Union agreed on a "new approach" to the
regulation of technical aspects of industrial products.
Where harmonization of legal requirements or administrative regulations
is necessary, the European Union develops regulations, which are called
Council Directives or simply directives.
Directives specify only the essential requirements that are general and
mandatory. The detailed technical specifications that may be used to
demonstrate conformity with the essential requirements are elaborated
in voluntary harmonized standards.
If a product complies with the requirements of a new approach directive,
the manufacturer marks it with the CE-mark:
Medical Devices Directive
- The „New Approach“ -
CE-marked goods are allowed free
movement within the internal market
throughout the territory of the
European Economic Area (EEA).
EEA = EU member states plus
Norway, Iceland and Liechtenstein
Approach has been adopted by
other states (e.g. Hungary, Czechia)
and is recognized in many other
countries.
Medical Devices Directive
- MDD, standards, and national legislation -
EU
Medical Devices Directive
Harmonized Standards
93/42/EWG
(MDD)
Medical Devices Act
(MPG)
National Organizations
Governments for Standardization
Medical Devices Directive
- Articles and Annexes -
23 articles (definitions, reference to standards, ...)
• Annex I Essential Requirements
• Annexes II-VIII Assessment Procedures
• Annex IX Classification Criteria
• Annex X Clinical Evaluation
• Annex XI Notified Bodies
• Annex XII CE Marking
Medical Devices Directive
- Definition of a Medical Device -
Any instrument, apparatus, appliance, material or other article,
whether used alone or in combination, including the software
necessary for its proper application, intended by the manu-
facturer to be used for human beings for the purpose of
diagnosis, prevention, monitoring, treatment or
alleviation of diseases, injuries, or handicaps,
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.
Medical Devices Directive
- Examples for Medical Devices -
wheel chairs
patient beds
wound dressings
respiration tubes
products for transition of blood
blood pressure monitoring
endoscopes
x-ray
MRI
artificial joints
prosthetic heart valves
artificial joint
all accessories of medical devices (e.g. electrodes)
Note: A medical device must have a proven efficacy for specific medical purposes.
Neither „Miracle Products“ nor general wellness products, cosmetic products,
S19
fitness apparatus etc. (e.g. muscle training apparatus, tooth whitener etc.)
are recognized as medical devices.
Medical Devices Directive
- Essential Requirements -
• General Requirements:
- state of the art safety of patients, operators and third persons
- device must achieve intended performances
• Chemical, physical and biological properties
• Infektion and microbial contamination (incl. sterility)
• Construction and environmental properties
• Measuring function
• Protection against radiation (incl. EMC)
• Safetey of external or internal energy supply
(electrical safety, software, alarm systems, etc.)
• Information, labelling, instructions for use
Medical Devices Directive
- Compliance with Essential Requirements -
EN 60601
Annex I: Electrical Presumption of
Essential Safety conformity for the
Requirements aspects that are
EN 30993
covered by the
Biological
• electrical Evaluation standard.
safety
• biological Application of
safety EN 550 ff.
harmonized
Sterilisation
• sterilisation standards is
• …. optional.
• ….
Medical Devices Directive
- Compliance with Essential Requirements -
requirement applicable? ensured by
12.6 Protection against yes application of EN 60601-1
electrial risks „Medical electrical equipment.
Part 1: General requirements
... avoid the risk of
for safety“
accidental electris
shocks during normal
use and in single fault
condition ...
S13
Medical Devices Directive
- Declaration of Conformity -
This Product
complies with
the Essential
Requirements
of the Directive
93/42/EEC.
The
Manufacturer
Medical Devices Directive
- Technical Documentation -
Product Description
• intended use / application scope / contra indications
• variations and approved accessories
• instructions for use / operation manual
• advertising materials / brochures / leaflets
Product Specification
• construction drawings, manufacturing plans, part lists
• essential requirements / list of applied standards
• manufacturing and sterilisation specifications
• QS specifications (SOP, testing plans)
• labelling and user information (EN 1041)
Product Verification
• risk analysis (EN 1441)
• test and inspection records, certificates
• clinical data / clinical assessment
Conformity Declaration
Medical Devices Directive
- Summary -
“New approach”:
Essential Requirements and harmonized standards
MDD
Definition “medical device”
Technical Documentation
Safety and Regulatory Affairs
3.
Conformity Assessment
Siemens AXIOM Artis BA
Conformity Assessment
- Introduction -
If a product complies with the requirements of a new approach
directive, the manufacturer signs a conformity declaration.
Depending on the potential risk of the device
certification by a Notified Body may be required.
If certification is a requirement as part of the conformity
assessment procedure, the manufacturer has the option to choose
any of the Notified Bodies in any of the Member States of the EU.
Products which require certification by a Notified Body carry the
CE-marking in combination with the number of the Notified Body,
for example:
Conformity Assessment
- Risk Classes -
18 classification rules (Annex IX)
low Risk high
sterile
or with a measuring
function
S17
Conformity Assessment
- Criteria for Risk Classification -
invasive / non-invasive
surgically invasive / non-surgically invasive
implantable / non-implantable
active / non-active
short-term / long-term use
application on „critical“ organs
(central nervous system, central blood circulation system)
intended use
Conformity Assessment
- Examples for Risk Classification -
Class I
wheel chairs, patient beds, non-invasive electrodes
Class I*
sterile wound dressings, thermometer
Class IIa
ultrasound diagnostic device, respiration tubes,
blood pressure monitoring devices,
products for transition of blood
Class IIb
artificial joints, lithotripthers
Class III
prosthetic heart valves, neurologic catheters
S19
Conformity Assessment
- Procedures -
manufacturer
Annex VII
notified body
Annex VII + Ann. II with
Annex design examination
sterile or with IV, V or VI
a measuring function:
Annex V Annex II Ann. III +
without design examination Ann. IV or V)
or
Ann. III + Ann. IV, V or VI
S20
Conformity Assessment
- Procedures -
Technical Documentation
I I* IIa IIb III IIa IIb III
Annex VII Annex II Annex II
Annex III
EC- Full Quality Full Quality
Declaration EC - Type Examination Assurance Assurance
of + Design
Conformity - 9001/46001 Examination
- 9001/46001
- Examination
I* IIa IIb I* IIa IIb III I* IIa IIb of Techn.Docu
I
Annex IV Annex V Annex VI
EC-Verification QA Production QA Product
- each device
- samples - 9002/46002 - 9003/46003
CE CE + Number of Notified Body
Conformity Assessment
- Type Examination & Verification -
EC-Type Examination
Notified Body examins technical documentation
and performs tests on a prototype to ensure
conformity with essential requirements
EC - Verification
Notified Body performs tests on every device or
samples from current production to ensure
conformity with technical documentation and
essential requirements
S19
Conformity Assessment
- Quality Assurance -
Notified Body performs audit of the manufacturers
quality assurance system.
QA-system has to apply to EN 9001 (general QA) and
EN 46001 (additional requirements to medical devices).
20/19 standard
ISO 9001/2 elements
additional
EN 46001/2 requirements
S19
Conformity Assessment
- Quality Assurance -
Element Additional Requirements acc. to EN 46001
2. Quality system – set up a product file
4. Design control – include safety requirements in design input data
– document design verification incl. clinical investications
8. Identification – establish procedures for traceability to facilitate
and traceability corrective action
– documented feedback system for early warning and
14. Corrective and corrective actions
preventive action – document and investigate all feedback incl. complaints
– maintain procedures for recall actions
– retain quality records for a time period at least equivalent
16. Quality records to the life-time of a product, but not less than 2 years
S19
Conformity Assessment
- Quality Assurance -
General Requirements acc. to EN 9001 (excerpt)
1. Management responsability
2. Quality system
3. Contract Review
4. Design control
6. Purchasing
7. Control of custumer-supplied product
8. Identification and traceability
9. Process Control
10. Inspection and testing
11. Control of inspection, measurement and test equipment
14. Corrective and preventive action
18. Training
20. Statistical techniques
S19
Conformity Assessment
- Steps to CE-Marking -
define intended use of the device
set up and maintain the technical
documentation incl. risk analysis
classify the device
choose a conformity assessment
procedure
perform conformity assessment
(if required with Notified Body)
issue the declaration of conformity
and affix the CE marking
Conformity Assessment
- Summary -
Possible conformity assessment procedure
depends on risk classification.
Procedures with / without
involvement of Notified Body.
Procedures based on product testing
or audit of quality assurance system.
Manufacturer chooses procedure
and procedure.
CE-mark with / without number
of Notified Body.
Safety and Regulatory Affairs
4.
exercise & discussion
Siemens AXIOM Artis BA
Safety and Regulatory Affairs
- Exercise -
Choose a medical device, then carry out
• Risk Analysis
• Basic Requirements & Standards
• Classification and choice of an appropriate
• Conformity Assessment Procedure
Safety and Regulatory Affairs
- Discussion -
Is a medical device that bears the CE-mark
save? Why?
Do you see any weak spots in the
current regulatory system?
Any other questions?
Heinz-Eckhard Schmittendorf
Safety and Regulatory Affairs
1. Introduction
2. The Medical Devices Directive
3. Conformity Assessment Procedure
4. Exercise and Discussion
Siemens AXIOM Artis BA
