Ce Marking Ho

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This is a presentation I made at a recent Institute of Physics and Engineering in Medicine meeting

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Ce Marking Ho

  1. 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 1
  2. 2. Medical Devices Why Regulate? Regulatory Intent To ensure only reliably safe and reliably effective medical devices are placed on the market 2
  3. 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 3
  4. 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. 4
  5. 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 5
  6. 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 6
  7. 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 7
  8. 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. 8
  9. 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 9
  10. 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 10
  11. 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. 11
  12. 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 12
  13. 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. 13
  14. 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 14
  15. 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 15

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