Electronic medical equipment.

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


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



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


– 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


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.



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


1. Introduction2. The Medical Devices Directive3. Conformity Assessment Procedure4. Exercise and Discussion

Electronic medical equipment.

Documents

Transcript of Electronic medical equipment.