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Medical devices for_the_eu_070910

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  • 1. Medical Devices for the EU Carl Youngmann, PhD Regulatory Affairs Certified Port Townsend, Washington (360) 379 3660 CYoungmann@gmail.com9/10/07 1
  • 2. 27 member states of theEuropean Union• Austria • Germany • Netherlands• Belgium • Greece • Poland• Bulgaria • Hungary Portugal• Cyprus • Ireland • Romania• Czech Republic • Italy • Slovakia• Denmark • Latvia • Slovenia • Spain• Estonia • Lithuania • Sweden• Finland • Luxembourg • United• France • Malta Kingdom9/10/07 2
  • 3. The European Free TradeAssociation (EFTA)• 3 of the 4 states of • The fourth state, the EFTA are part of Switzerland, has the EEA internal bilateral agreements market: with the EEA. – Iceland – Norway – Liechtenstein9/10/07 3
  • 4. US versus EU Medical DeviceRegulation• Directives to Member States – Implemented by Member State parliaments in national legislation – Overseen by national Competent Authorities – Compliance checked by Notified Bodies – Enforcement under national jurisdiction• Based on compliance not notice or approval• No EU centralized authority• Different approach to determining standard of care: national health systems,9/10/07 4
  • 5. The U.S. compared to the E.U.-1 US specific Shared EU specificQuality System 21 CFR 820 ISO 13485 More definitions Few definitions Quality Plan Quality System Quality Planning & Policy Management responsibility Audits Personnel / Training Design Controls9/10/07 5
  • 6. The U.S. compared to the E.U.-2 US specific Shared EU specificQuality System, Purchasingcontinued Product Identification Process Control Inspection Measurement & Test Equipment Nonconforming Product Corrective & Preventative Action9/10/07 6
  • 7. The U.S. compared to the E.U.-3 US specific Shared EU specificQuality System, Labeling Packaging Translationcontinued Device Master Record Device History Record Handling, Storage & Delivery Installation Quality Records Complaints9/10/07 7
  • 8. The U.S. compared to the E.U.-4 US specific Shared EU specificQuality System, Servicingcontinued Statistical TechniquesRisk Management ISO 14971Product FDA Guidance Biocompatibility MDD EssentialRequirements Requirements Electrical Safety Electromagnetic Compatibility9/10/07 8
  • 9. The U.S. compared to the E.U.-5 US specific Shared EU specificProduct SterileRequirements Packagingcontinued shelf-life sterile barrier shipping Sterilization ValidationPost Market MDR Recalls & Post Market Removals SurveillanceRegulatory 510(K), IDE & Technical FileCompliance PMA CE-MarkingRepresentation U. S. Agent for Authorized Devices European Representative9/10/07 9
  • 10. The U.S. compared to the E.U.-6 US specific Shared EU specificClinical IDE ISO 14155-1, -2Assessments Inspections Audits biennial GMP initial pre-PMA continuing9/10/07 10
  • 11. The CE Mark• Possibly Communitee Européen, French for European Community.• Could be Conformité Européen.• Invented by some bureaucrat in Brussels.• Officially, just a logo and has no linguistic meaning.9/10/07 11
  • 12. Medical Device Directives• Medical Devices — Council Directive 93/42/EEC of 14 June 1993 (OJ No L 169/1 of 1993-07-12)• Active Implantable Medical Devices — Council Directive 90/385/EEC of 20 June 1990 (OJ No L 189/17 of 1990-07-20)• In-vitro diagnostic medical devices — Directive 98/79/EC of 27 October 1998 (1998-12-07 OJ No L 331/1)9/10/07 12
  • 13. Recent Changes to the MDD• Clarification of design documentation and design review requirements• Clarification of the clinical evaluation requirements• Substances of animal origin or containing human blood• Software validation• Alignment of the original MDD 93/42/EEC with other directives9/10/07 13
  • 14. Council Directive 93/42/EEC 14 June1993 concerning medical devices — 1• 23 Articles – Classification – Definitions, scope – Conformity assessment – Placing on the market and procedures putting into service – Registration of persons – Essential requirements responsible for placing devices on the market – Free movement, devices intended for special purposes – Clinical investigation – Reference to standards – Notified bodies – Committee on Standards and – CE marking and Wrongly Technical Regulations affixed CE marking – Safeguard clause – Confidentiality – Information on incidents – Implementation, transitional occurring following placing of provisions9/10/07 devices on the market 14
  • 15. Council Directive 93/42/EEC 14 June1993 concerning medical devices — 2• 12 Annexes I Essential Requirements II EC Declaration of Conformity (Full Quality Assurance – ISO 13485 + MDD ) III EC Type - Examination IV EC Verification i.e. batch testing V EC Declaration of Conformity (Production Quality Assurance – ISO 13485 MDD) VI EC Declaration of Conformity (Product Quality Assurance – ISO 13485 + MDD)9/10/07 15
  • 16. Council Directive 93/42/EEC 14 June1993 concerning medical devices — 3• 12 Annexes VII EC Declaration of Conformity, self- certification for Class I products VIII Statement concerning devices for special purposes IX Classification criteria i.e. rules for the classification of products X Clinical evaluation XI Criteria for the designation of Notified Bodies XII CE Marking of conformity9/10/07 16
  • 17. CE-Marking Medical Devices• Classify the device• Assess device conformity – Essential Requirements – Risk Management – Certification Procedures • Performance • Quality – Labeling – Technical construction file or design dossier• Authorize a European representative• CE mark the product9/10/07 17
  • 18. MDD Device Classification• Duration of use: transient, short-term or long-term• Invasiveness: non-invasive, body orifice, surgically invasive, implantable• Activity: therapeutical or diagnostic• Central circulatory contact• Central nervous system contact MDD Annex IX9/10/07 18
  • 19. 4 ( Really 6 ) Device Classes — 1• Class I – low risk – non-sterile dressings – bandages – hospital gowns – light sources• Class I (Sterile) – disposable surgical instruments – urine drainage bags9/10/07 19
  • 20. 4 ( Really 6 ) Device Classes — 2• Class I (Measuring) – scales – digital thermometers• Class IIa – medium risk – IV catheters – tubings for anesthesia / ventilation – ultrasound devices9/10/07 20
  • 21. 4 ( Really 6 ) Device Classes — 3• Class IIb – elevated risk – intra-ocular lenses – breast implants – endoprostheses – ventilators• Class III – high risk – heart valves – reabsorbable implants9/10/07 21
  • 22. Class I Conformity Assessment• Manufacturer self-declares conformity for performance and for quality system• Aspects of sterile products and measuring devices relating to sterility and/or metrology are certified by a Notified Body.9/10/07 22
  • 23. Class IIa Conformity Assessment• Manufacturer self-declares conformity for performance and for design control• Notified Body must – certify full quality assurance system – certify production quality assurance system – certify final inspection and testing; or – exam and test sample products.9/10/07 23
  • 24. Class IIb Conformity Assessment• Notified Body will either certify full quality assurance system or test and certify product performance and certify production quality assurance system9/10/07 24
  • 25. Class III Conformity Assessment• Notified Body will certify full quality assurance system and certify the technical dossier9/10/07 25
  • 26. Technical Construction File (Class I & II)or Design Dossier (Class III) • Essential Requirements Analysis – Product design specifications – Hazard and risk analysis – Verification and validation reports • Engineering test reports • Laboratory reports • Clinical validation – Product labeling • A combination of elements from the Design History File and the Device Master Record 9/10/07 26
  • 27. Declaration of Conformity• Document created by the person placing the device on the market that clearly identifies: – The manufacturer or their AER – Manufacture’s or AER’s European Address – The device (models, serial numbers, lots, etc.) – The applicable directives – The major standards complied with – Signed by a responsible authority• Included in the device labeling, usually in the instructions for use and shipping documents9/10/07 27
  • 28. Lumps in the Level Playing Field• Each Member State was permitted to impose requirements particular to their national cultures, i.e., use of languages indigenous to their countries9/10/07 28
  • 29. EU National Language Requirements -1 Austria German Belgium Dutch + German + French (All three must be used for patient instructions) Bulgaria English, Bulgarian for self-test devices only. Croatia (Pending Croatian EU state) Cyprus Non-professional use devices in Greek. Professional Use devices in Greek or English Czech Republic Czech Denmark Danish Estonia Estonian 9/10/07 29
  • 30. EU National Language Requirements - 2 Finland Finnish + Swedish France French Germany German Greece Greek Hungary Hungarian Iceland (EFTA) Icelandic Ireland English Italy Italian 9/10/07 30
  • 31. EU National Language Requirements - 3 Latvia Latvian for professional use; English or German is accepted Liechtenstein German (EFTA) Lithuania Lithuanian Luxembourg French Macedonia (Pending EU State) Malta Maltese or English Netherlands Dutch Norway (EFTA) Norwegian 9/10/07 31
  • 32. EU National Language Requirements - 4 Poland Polish Portugal Portuguese Romania Romanian Serbia Serbian Slovakia Slovak Slovenia Slovenian Spain Spanish Sweden Swedish 9/10/07 32
  • 33. EU National Language Requirements - 5 Switzerland French, German, Italian (EFTA) Turkey (Pending Turkish EU State) United Kingdom English 9/10/07 33
  • 34. How to label a device formarketing in Europe - 1• Highly simplified instructions – Fourth grade vocabulary – Simple declarative sentences – No or minimal medical terminology – Maximum use of graphics• Graphics!9/10/07 34
  • 35. How to label a device formarketing in Europe - 2• Limit marketing to a few of the largest countries, e.g., UK (61M), France (64M), Germany (84M), Italy (54M) & Spain (45M) to reach 62% of the 494M EU residents – Label only for those markets• Sell products F.O.B. in market countries, others in the EU can purchase across borders• Require training for professionals and service personnel where more complete materials can be provided in English9/10/07 35
  • 36. Post-Market Surveillance• Manufacturer must establish systems to – Record and analyze customer responses – Process customer complaints – Collect, report and analyze any adverse events – Actively monitor use and abuse of the product9/10/07 36
  • 37. Authorized European Representative(AER)• A point of contact within the EU where the Competent Authorities can serve notices• Generally not a sales office or a business facility• Required to be shown on all labeling• Only one required for the entire EU – Establishes the country of legal jurisdiction for criminal and civil actions, including insurance• Should be knowledgeable in the mechanics of the MDD• May be required to respond within 2-3 days with technical file9/10/07 37
  • 38. Questions?• Ask the EU Commission: ec.europa.eu/enterprise/medical_devic es/index_en.htm9/10/07 38

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