The document provides an overview of CE marking requirements for medical devices in Europe. It discusses regulations that require medical devices to be safely and effectively designed and developed. Regulations are in place to ensure devices placed on the market do not compromise patient safety or health. Manufacturers must implement a risk management system and conduct clinical evaluations or reviews of scientific literature to demonstrate a device's safety and performance. Notified bodies assess and provide approval for higher risk devices. Manufacturers must maintain technical files and address post-market surveillance requirements. Standards can be used to demonstrate compliance with regulatory requirements.

1. Health Design and Technology Institute
Challenges in Medical Device Design and Development
An Overview of CE Marking of Medical Devices
4th December 2008
James Love
Director
Innoventions International Ltd
James Love
• Industry Experience
– Motor Cycles
– Automotive
– Industrial Equipment
– Chemicals
– Management Development
– Appliances
– Medical Devices
• Medical Technologies
Special Interest Group
Chartered Quality Institute
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2. Medical Devices
Why Regulate?
Regulatory Intent
To ensure only
reliably safe and reliably effective
medical devices are placed on the
market
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3. Management Influence
Knowledge Concept Detail Prototype Pilot Production
acquisition design design building production ramp-up
High
Ability to
influence
outcome
Actual management
activity profile
Low
Time
Ref: Dynamic Manufacturing - Hayes, Wheelwright & Clark
Measure - Engineering Changes
Japanese
Western
Manufacturers
Manufacturers
No. of design changes
Detail
Concept Prototype/ Process
JOB 1
Design Testing Design/Manufacture
Design
Time
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4. Regulatory Intent
To ensure only
reliably safe and reliably effective
medical devices are placed on the
market
Safe
The devices must be designed and manufactured in
such a way that, when used under the conditions and
for the purposes intended, they will not compromise the
clinical condition or the safety of patients, or the safety
and health of users or, where applicable, other persons,
provided that any risks which may be associated with
their use constitute acceptable risks when weighed
against the benefits to the patient and are compatible
with a high level of protection of health and safety.
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5. Safe
2007 revision of the directive adds:
This shall include:
- reducing, as far as possible, the risk of use error due
to the ergonomic features of the device and the
environment in which the device is intended to be used
(design for patient safety), and
- consideration of the technical knowledge, experience,
education and training and where applicable the
medical and physical conditions of intended users
(design for lay, professional, disabled or other users).
EN ISO 14971:2007
Risk Management
Risk Assessment
Evaluation of overall
Risk analysis Risk control
residual risk acceptability
• Risk control option analysis
• Intended use and identification • Implementation of risk control
of characteristics related to the measure(s)
safety of the medical device • Residual risk evaluation
Risk management report
• identification of Hazards • Risk/benefit analysis
• Estimation of the risk(s) for each • Risks arising from risk control
hazardous situation measures
• Completeness of risk control
Production and post-
production information
Risk evaluation
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6. Risk Analysis Tools
Reliability QRA Reliability
Apportionment Simulation
Level of Risk
ETA/FTA/CCA
SWIFT HAZOP FMECA
Open Checklists What-if HEA SHERPA FMEA
Brainstorming
Option Outlines Concept Design Detailed Design
Project Progress
EN ISO 14971:2007
Risk Management
Risk Assessment
Evaluation of overall
Risk analysis Risk control
residual risk acceptability
• Risk control option analysis
• Intended use and identification • Implementation of risk control
of characteristics related to the measure(s)
safety of the medical device • Residual risk evaluation
Risk management report
• identification of Hazards • Risk/benefit analysis
• Estimation of the risk(s) for each • Risks arising from risk control
hazardous situation measures
• Completeness of risk control
Production and post-
production information
Risk evaluation
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7. Risk control option analysis
• Inherent safety by design
• Protective measures in the medical device
itself or in the manufacturing process
• Information for safety
Language
Czech Danish
Dutch English
Estonian Finnish
French German
Greek Hungarian
Icelandic Irish
Italian Latvian
Lithuanian Luxembourgish
Maltese Norwegian
Polish Portuguese
Slovakian Slovenian
Spanish Swedish
Walloon
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8. Risk Acceptance Policy
• Risk Benefit using same units
• If this is not possible use Quality Adjusted Life
Years (QALY)
Vigilance and Post Market
Surveillance
An undertaking by the manufacturer to institute and keep up to date a
systematic procedure to review experience gained from devices in
the post-production phase and to implement appropriate means to
apply any necessary corrective action.
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9. Vigilance and Post Market
Surveillance
This undertaking must include an obligation for the manufacturer to
notify the competent authorities of the following incidents immediately
on learning of them:
(i) any malfunction or deterioration in the characteristics and/or
performance of a device, as well as any inadequacy in the
instructions for use which might lead to or might have led to the death
of a patient or user or to a serious deterioration in his state of health;
(ii) any technical or medical reason connected with the characteristics
or performance of a device leading for the reasons referred to in
subparagraph (i) to systematic recall of devices of the same type by
the manufacturer.
Effective
Clinical Evaluation
• Critical evaluation of a clinical study
• Or
• Critical evaluation of the relevant scientific
literature currently available relating to the
safety, performance, design characteristics
and intended purpose of the device
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10. Reliably
Design for manufacture and process capability
and
BS EN ISO 13485:2003 – Medical devices –
Quality management systems – Requirements
for regulatory purposes
Reliably
BS EN ISO 13485:2003 has the same structure
as BS EN ISO 9001:2000, but, where the latter
requires only 6 procedures, the former requires
23+ procedures
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11. Reliably
Verification and
Validation Plan
Production Functionality Reliability Performance Approvals User Operation
End of Line Functionality Normal Simulated
FDA
MTBF Tests
Test Test Performance Use
Out of Box Regression Extreme Clinical
EU
Life Tests
Audit Test Performance Trials
Consumables
Other User Tests
Other
Accelerated
Tests
Product Nations
Life Tests
Specific
User Abuse
Transit
Tests
Tests
Environmental
Stress
Abuse Test
Use of EN Standards
Article 5 of directive 93/42/EEC
Member States shall presume compliance with the essential
requirements referred to in Article 3 in respect of devices which are
in conformity with the relevant national standards adopted pursuant
to the harmonized standards the references of which have been
published in the Official Journal of the European Communities;
Member States shall publish the references of such national
standards.
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12. Use of EN Standards
Implications
Use EN standard (if there is one), otherwise
Use ISO standard (if there is one), otherwise
Use BS standard (if there is one), otherwise
Use standard from another EU country (if there is one), otherwise
Use standard from another country (if there is one), otherwise
Develop an internal standard
Use of EN Standards
List of standards published in the
Official Journal
http://ec.europa.eu/enterprise/newapproach/stan
dardization/harmstds/reflist/meddevic.html
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13. Technical File
• Controlled document
• Dynamic
• Documents how the regulatory requirements
have been fulfilled for a particular device/group
of similar devices
Notified Bodies
• Devices are classed according to risk, Class I, Class
IIa, Class IIb and Class III
• Notified Bodies become involved if the device is a
Class IIa or higher device or, in the case of a Class I
device, if it is placed on the market in a sterile
condition or if it has a measuring function.
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14. Notified Bodies
• UK Notified Bodies are appointed by the Competent
Authority – the Medicines and Healthcare products
Regulatory Agency
http://www.mhra.gov.uk/Howweregulate/Devices/NotifiedBodies/UKN
otifiedBodiesundertheMedicalDevicesDirectives/index.htm
• For other Notified Bodies go to:
http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseacti
on=directive.main
and click on 93/42/EEC Medical Devices
Questions
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15. James Love
Director
Innoventions International Ltd
121 Meeting House Lane
Balsall Common
Coventry
CV7 7GD
james@innoventionsinternational.co.uk
Tel: 01676 532386
Fax: 01676 532181
Mobile: 07817 258473
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