Electronic medical Electronic medical equipment. equipment.
Jan 04, 2016
Electronic medical equipment.Electronic medical equipment.
Medical EngineeringMedical Engineering
medical facilities Medical Apparatus Medical instrument
By type use energy
electromedical apparatus
Mechanical electromedical apparatus
by direction energy flow
Have action devices Perceptive devices
PerceptivePerceptive devicesdevices
By type energy, perceptive
chemical energylight energy
heat energy electrical energy Mechanical energy
Have action devicesHave action devices
therapeutic diagnostical
electrical energy
mechanical energy
mechanical
hydraulic
light - optical
gas
ultra sound
low frequency X-ray
by function
By type influence
high frequency
Electromagnetic Energy Electromagnetic Energy ExchangeExchangeis bidirectional
Technical Technical FrequenciesFrequencies
electromelectromedical edical aapparatuspparatus
• sensor,sensor,• converter,converter,• Output deviceOutput device• Power sappyPower sappy
Heinz-Eckhard Schmittendorf Safety and Regulatory Affairs
Siemens AXIOM Artis BA
1. Introduction2. The Medical Devices Directive3. Conformity Assessment Procedure4. Exercise and Discussion
What is the intended use of the device?• •
What potential risks do you see?• •
Assess these risks. Are they acceptable?• •
Safety and Regulatory Affairs / Introduction
What can the manufacturer doto 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
risk acceptable?
reduce risk
remaining risk acceptable?re-design
yes
yes
risk analysis report / review
Safety and Regulatory Affairs / Introduction- Risk Analysis According to EN 1441 -
Failure Mode and Effect Analysis (FMEA)
fault mode safety means S P D R S P D R ok?
power outage (device stops)
emergency power system
8 1 10 80 1 1 10 10 ok
contact with hot wire(electrical shock)
application ofstandard EN 60601-1
8 4 4 128 8 1 4 32 ok
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
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
Safety and Regulatory Affairs / Introduction- Summary -
Documentation is necessary to demonstate appropriate risk management
Safety and Regulatory Affairs
Siemens AXIOM Artis BA
2.The Medical Devices Directive
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 -
Organizations for Standardization
Harmonized StandardsMedical Devices Directive
93/42/EWG(MDD)
EU
Medical Devices Act(MPG)
NationalGovernments
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, Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software whether used alone or in combination, including the software necessary for its proper necessary for its proper application, intended by the manu-application, intended by the manu-facturerfacturer to be used for human beings for the purpose of to be used for human beings for the purpose of
diagnosis, prevention, monitoring, treatment or diagnosis, prevention, monitoring, treatment or alleviation of diseases, injuries, or handicaps,alleviation of diseases, injuries, or handicaps,
investigation, replacement or modification of the anatomy investigation, replacement or modification of the anatomy or of a physiological process,or of a physiological process,
control of conception,control of conception,
and which does not achieve its principal intended action in or on and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic the human body by pharmacological, immunological or metabolic means.means.
wheel chairswheel chairs patient bedspatient beds wound dressingswound dressings respiration tubesrespiration tubes products for transition of bloodproducts for transition of blood blood pressure monitoringblood pressure monitoring endoscopesendoscopes x-rayx-ray MRI MRI artificial jointsartificial joints prosthetic heart valvesprosthetic heart valves artificial jointartificial joint all accessories of medical devices (e.g. electrodes)all accessories of medical devices (e.g. electrodes)
S19
Medical Devices Directive- Examples for Medical Devices -
Note: Note: A medical device must have a proven efficacy for specific medical purposes. A medical device must have a proven efficacy for specific medical purposes. Neither „Miracle Products“ nor general wellness products, cosmetic products, Neither „Miracle Products“ nor general wellness products, cosmetic products, fitness apparatus etc. (e.g. muscle training apparatus, tooth whitener etc.) fitness apparatus etc. (e.g. muscle training apparatus, tooth whitener etc.) are recognized as medical devices.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
Annex I:Essential
Requirements
• electrical safety
• biological safety
• sterilisation
• ….
• ….
EN 60601Electrical
SafetyPresumption of
conformity for the aspects that are covered by the
standard.
Application of harmonized standards is
optional.
EN 30993BiologicalEvaluation
EN 550 ff.Sterilisation
Medical Devices Directive- Compliance with Essential Requirements -
S13
Medical Devices Directive- Compliance with Essential Requirements -
application of EN 60601-1 „Medical electrical equipment. Part 1: General requirements for safety“
requirement applicable? ensured by
12.6 Protection against electrial risks
... avoid the risk of accidental electris shocks during normal use and in single fault condition ...
yes
This Product complies with the Essential Requirements
of the Directive
93/42/EEC.The Manufactur
er
Medical Devices Directive- Declaration of Conformity -
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- Technical Documentation -
“New approach”: Essential Requirements and harmonized standards
Medical Devices Directive - Summary -
Technical Documentation
Definition “medical device”
MDD
Safety and Regulatory Affairs
Siemens AXIOM Artis BA
3.Conformity Assessment
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:
18 classification rules (Annex IX)
low Risk high
I IIIIIbIIaI *
sterile or with a measuring
function
S17
Conformity Assessment- Risk Classes -
invasive / non-invasiveinvasive / non-invasive
surgically invasive / non-surgically invasivesurgically invasive / non-surgically invasive
implantable / non-implantableimplantable / non-implantable
active / non-activeactive / non-active
short-term / long-term useshort-term / long-term use
application on „critical“ organs application on „critical“ organs (central nervous system, central blood circulation system)(central nervous system, central blood circulation system)
Conformity Assessment- Criteria for Risk Classification -
intended useintended use
Class IClass Iwheel chairs, patient beds, non-invasive electrodeswheel chairs, patient beds, non-invasive electrodes
Class I*Class I*sterile wound dressings, thermometersterile wound dressings, thermometer
Class IIaClass IIaultrasound diagnostic device,ultrasound diagnostic device, respiration tubes, respiration tubes, blood pressure monitoring devices, blood pressure monitoring devices, products for transition of bloodproducts for transition of blood
Class IIbClass IIbartificial joints, lithotripthersartificial joints, lithotripthers
Class IIIClass IIIprosthetic heart valves, neurologic cathetersprosthetic heart valves, neurologic catheters
S19
Conformity Assessment- Examples for Risk Classification -
I IIIIIbIIa
man
ufa
ctu
rer
Ann. II with design examination
Annex VII + Annex
IV, V or VI
Annex II without design examination
or Ann. III + Ann. IV, V or VI
Annex VII
sterile or with a measuring function:
Annex V
no
tifi
ed b
od
y
Ann. III + Ann. IV or V)
I *
S20
Conformity Assessment- Procedures -
Technical Documentation
Annex VII
EC-Declaration ofConformity
Annex III
EC - Type Examination
Annex II
Full Quality Assurance
- 9001/46001
Annex II
Full Quality Assurance+ Design Examination
- 9001/46001- Examination of Techn.Docu
Annex IV
EC-Verification- each device- samples
Annex V
QA Production
- 9002/46002
Annex VI
QA Product
- 9003/46003
CE CE + Number of Notified Body
I I* IIa IIb III IIa IIb III
I* IIa IIb III I* IIa IIbI* IIa IIb
I
Conformity Assessment- Procedures -
EC-Type ExaminationEC-Type Examination
Notified Body examins technical documentation Notified Body examins technical documentation and performs tests on a prototype to ensure and performs tests on a prototype to ensure conformity with essential requirements conformity with essential requirements
EC - VerificationEC - Verification
NotifiedNotified Body performs tests on every device or Body performs tests on every device or samples from current production to ensure samples from current production to ensure conformity with technical documentation and conformity with technical documentation and essential requirements essential requirements
S19
Conformity Assessment- Type Examination & Verification -
Notified Body performs audit of the manufacturers Notified Body performs audit of the manufacturers quality assurance system.quality assurance system.
QA-system has to apply to EN 9001 (general QA) and QA-system has to apply to EN 9001 (general QA) and EN 46001 (additional requirements to medical devices).EN 46001 (additional requirements to medical devices).
S19
Conformity Assessment- Quality Assurance -
ISO 9001/2
EN 46001/2 additional requirements
20/19 standard
elements
S19
Conformity Assessment- Quality Assurance -
– establish procedures for traceability to facilitate corrective action
8. Identification and traceability
– include safety requirements in design input data – document design verification incl. clinical investications
4. Design control
– set up a product file2. Quality system
Additional Requirements acc. to EN 46001Element
– documented feedback system for early warning and corrective actions – document and investigate all feedback incl. complaints– maintain procedures for recall actions
14. Corrective and preventive action
– retain quality records for a time period at least equivalent to the life-time of a product, but not less than 2 years16. Quality records
S19
Conformity Assessment- Quality Assurance -
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
General Requirements acc. to EN 9001 (excerpt)
define intended use of the devicedefine intended use of the device
set up and maintain the technicalset up and maintain the technicaldocumentation incl. risk analysisdocumentation incl. risk analysis
classify the deviceclassify the device
choose a conformity assessment choose a conformity assessment procedureprocedure
perform conformity assessment perform conformity assessment (if required with Notified Body) (if required with Notified Body)
issue the declaration of conformity issue the declaration of conformity and affix the CE markingand affix the CE marking
Conformity Assessment- Steps to CE-Marking -
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.
Conformity Assessment- Summary -
CE-mark with / without numberof Notified Body.
Manufacturer chooses procedure and procedure.
Safety and Regulatory Affairs
Siemens AXIOM Artis BA
4.exercise & discussion
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
Is a medical device that bears the CE-mark save? Why?
Do you see any weak spots in the current regulatory system?
Safety and Regulatory Affairs- Discussion -
Any other questions?
Heinz-Eckhard Schmittendorf Safety and Regulatory Affairs
Siemens AXIOM Artis BA
1. Introduction2. The Medical Devices Directive3. Conformity Assessment Procedure4. Exercise and Discussion