1. Electronic medical equipment.

2. Medical 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

3. Perceptive devices By type energy, perceptive light energy
chemical energy
heat energy
electrical energy
Mechanical energy

4. Have action devices by function therapeutic diagnostical
By type influence
mechanical energy
electrical energy
X-ray
low frequency
gas
hydraulic
light - optical
ultra sound
mechanical
high frequency

5. Electromagnetic Energy Exchange
is bidirectional

6. Technical Frequencies
The technical frequencies table gives you an idea about the use and about the compatibility problems that arise from overlapping spectra.
Overlapping spectra must be kept apart by appropriate measures.
This is precisely the aim of EMC as a science and as a collection of rules.

7. electromedical apparatus
sensor,
converter,
Output device
Power sappy

9. Heinz-Eckhard Schmittendorf Safety and Regulatory Affairs
Siemens AXIOM Artis BA
1. Introduction
2. The Medical Devices Directive
3. Conformity Assessment Procedure
4. Exercise and Discussion

10. 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?

11. Safety and Regulatory Affairs / Introduction
- Risk Analysis According to EN
identify characteristics & intended use
identify possible hazards
estimate risk for each hazard
risk acceptable?
reduce risk
remaining risk acceptable?
re-design
yes
risk analysis report / review

12. Safety and Regulatory Affairs / Introduction
- Risk Analysis According to EN
Failure Mode and Effect Analysis (FMEA)
fault mode
safety means S P D R
ok?
power outage (device stops)
emergency power system 8 1 10 80 ok
contact with hot wire (electrical shock)
application of standard EN 8 4
128 1 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 ( ), threshold of acceptability = 50

13. 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

14. Safety and Regulatory Affairs
Siemens AXIOM Artis BA 2.
The Medical Devices Directive

15. 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:
                  

16. 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.

17. Medical Devices Directive - MDD, standards, and national legislation -
93/42/EWG
(MDD) EU
Organizations for Standardization
Harmonized Standards
Medical Devices Act (MPG)
National
Governments

18. 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

19. 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.

20. 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, fitness apparatus etc. (e.g. muscle training apparatus, tooth whitener etc.) are recognized as medical devices.
S19

21. 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

22. Medical Devices Directive - Compliance with Essential Requirements -
EN Electrical Safety
Annex I: Essential Requirements
electrical safety
biological safety
sterilisation ….
Presumption of conformity for the aspects that are covered by the standard.
Application of harmonized standards is optional.
EN Biological Evaluation
EN 550 ff. Sterilisation

23. Medical Devices Directive - Compliance with Essential Requirements -
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
application of EN „Medical electrical equipment. Part 1: General requirements for safety“
S13

24. Medical Devices Directive - Declaration of Conformity -
This Product complies with the Essential Requirements of the Directive 93/42/EEC.
The Manufacturer

25. 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

26. Medical Devices Directive
- Summary -
“New approach”: Essential Requirements and harmonized standards
MDD
Definition “medical device”
Technical Documentation

27. Safety and Regulatory Affairs
Siemens AXIOM Artis BA 3.
Conformity Assessment

28. 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:

29. Conformity Assessment
- Risk Classes -
18 classification rules (Annex IX)
I *
sterile or with a measuring function I
IIa
IIb
III
low Risk high
S17

30. 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

31. 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

32. Conformity Assessment
- Procedures -
manufacturer
Annex VII I
I *
IIa
IIb
III
Ann. II with design examination
Annex VII + Annex IV, V or VI
sterile or with a measuring function: Annex V
notified body
Annex II without design examination or Ann. III + Ann. IV, V or VI
Ann. III + Ann. IV or V)
S20

33. Conformity Assessment
- Procedures -
Technical Documentation
Annex VII
EC- Declaration of Conformity
Annex III
EC - Type Examination
Annex II
Full Quality Assurance
- 9001/46001
+ Design Examination
- 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 IIb I

34. 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

35. Conformity Assessment additional requirements
- Quality Assurance -
Notified Body performs audit of the manufacturers quality assurance system.
QA-system has to apply to EN 9001 (general QA) and EN (additional requirements to medical devices).
ISO 9001/2
20/19 standard elements
EN 46001/2
additional requirements
S19

36. Conformity Assessment
- Quality Assurance -
Element
Additional Requirements acc. to EN 46001
2. Quality system
– set up a product file
– include safety requirements in design input data – document design verification incl. clinical investications
4. Design control
8. Identification and traceability
– establish procedures for traceability to facilitate corrective action
– 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 years
16. Quality records
S19

37. 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

38. 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

39. 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.

40. Safety and Regulatory Affairs
Siemens AXIOM Artis BA 4.
exercise & discussion

41. 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

42. 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?

43. Heinz-Eckhard Schmittendorf Safety and Regulatory Affairs
Siemens AXIOM Artis BA
1. Introduction
2. The Medical Devices Directive
3. Conformity Assessment Procedure
4. Exercise and Discussion