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