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View Full Version : CE Marking (Conformité Européene) / CB Scheme

  1. CE Mark Myths - The Medical Device Directive's Seven Major Myths
  2. ISO 9001 vs. CE Mark European directives
  3. CE Mark Auditing - All they had for CE was a written Technical Justification
  4. Is ISO 13485:2003 Certification neccessary to get the CE Mark?
  5. CE marking and RUO (Research Use Only) products - Distributing in vitro products
  6. CE-marked devices require EN ISO 14971 risk management
  7. Getting CE Mark - What is the process of getting it?
  8. What's the gap between CE-marking and FDA's approval?
  9. CE Mark & Harmonized Standards - Article 5.1, MDD - Has anyone challanged this?
  10. CE Marking for Class I Medical Devices - Self-declare CE marking?
  11. CE Mark Medical Devices - Annexes II, IV, V and VI
  12. CE Mark - FDA - Class I traction systems - What is involved and how long does it take
  13. CE Mark "piggybacking" on suppliers technical files - Looking for contract example
  14. CE marking - Medical Device - Must have our name and address on it?
  15. CE Marking Question - Class IIa device by complying with Annex V & VII
  16. CE Marking for Power Supply for Medical Device - Class IIb device per MDD, Rule 11
  17. CE Mark Question, Manufactuerer or distributor, steps the same?
  18. CE mark - Trying to determine if our product needs CE approval
  19. CE Mark & Harmonized Standards
  20. Obtaining the CE Mark from TUV
  21. CE marking, required for prototypes? New technology lighting source
  22. MDD and CE Mark Registration - What will the technical expert look for?
  23. CE Mark Database akin to 510 (k) database?
  24. Instructions for Use - Ob/Gyn products sold in Europe - CE mark and the NB number
  25. CE requirement for software importer / reseller - Class II for FDA and Health Canada
  26. Radio & Telecommunications Terminal Equipment Directive 1999/5/EC
  27. What Class 1 Medical Device Registration is required to sell in Poland
  28. CE Mark requirements for Class IIA MDs - European medical devices importers
  29. CE Marking for cast iron, cast steel, and bronze Industrial Valves
  30. Big Shipping Error - Shipped without the CE mark on them - Need advice!
  31. Non-sterile liquid bandage as Class 1 - Anyone concur or disagree?
  32. Class I Medical Device - What is in a CE Marking Self-Declaration
  33. What function normally updates/maintains the Technical File?
  34. European MDD Classification of Medical Devices (Risk Class)
  35. CB Scheme IEC 61010 / IEC 60601...+ NRTL mark
  36. Harmonization date of IEC 60601-1 , 3rd Edition
  37. Application of ISO 14155 Clinical Trials Investigations
  38. Preparing the Technical File for a 12 Lead ECG Monitor
  39. Requirements for Updating a Medical Device Technical File
  40. A need for CE Marking? Structural Steel
  41. MDD confomity assessment - ISO 13485 registration counts for nothing???
  42. Comparison of ISO 14155 to FDA Good Clinical Practice
  43. CE Marking MDD & EN 980 Labeling Requirements, IFU, Packaging, etc.
  44. The status of the 2005 ammendments to the MDD (Medical Device Directive)?
  45. GMDN (Global Medical Device Nomenclature) Codes
  46. New List of Harmonized Standards MDD
  47. CE-Mark for Ceramic Tiles
  48. International Symbols in Metrology and Calibration
  49. Requirements for Declaration of Conformity - Compliance to MDD
  50. Which Harmonized Standard to which Essential Requirement
  51. CE Marking Issue- this seems illegal to me...
  52. Revision of MDD 93/42/EEC, AIMD 90/385/EEC and BPD 98/8/EC published: 2007/47/EC
  53. Requirements for CE marking a component to go into an assembly (PED)
  54. CE Mark for Surgical Gowns & Surgical Drapes
  55. Medical Device (MedDev) Vigilance Guidelines for Importers into the UE
  56. MDD for Drug Product for CE Marking
  57. Multiple Applied Parts - Cardiac Floating (CF), Body Floating (BF) Marking
  58. What is the Process for CE Marking a Flight Simulator
  59. CE Marking Specific Discussion or Forum Web Sites
  60. Minimizing cost of product certification - int/ext CE certified Powersupply Unit?
  61. Active Medical Devices - An example of an Active Medical Device and Definition
  62. CE Mark / TCF (Technical Construction File) File sample
  63. New MDD Consolidated Version Published
  64. Declaration of Conformity - Conformance with more than one directive
  65. CE mark for photo frames albums for UK
  66. Experience with IMB as Competent Authority of Drug Device Combination Products?
  67. CB (Certification Body /Competent Body) and CE (European Mark of Conformity)?
  68. CE Marking outside of Europe?
  69. Independent authorized CE Marking representative in UK or EU - Class 1 Medical Device
  70. Medical Device Vigilance System Requirements - CE Mark Products
  71. CE marking of products - How do you know if your product requires it?
  72. Implications on the Legal Status of the "Declaration of Conformity"
  73. CE Mark Requirements for Dentist Chair
  74. Sales in Europe of CE marked Medical devices with sister company
  75. Finally! CE Mark capable
  76. CE Marking Process - Obligations of an Authorized Representative
  77. Medical Products: CE Marking - Are the DMR's, Technical Files, DHF, required?
  78. PED (Pressure Equipment Directive) Certification - We hold an ASME 'S' stamp
  79. Comparison between MDD and AIMD
  80. Accessory (CE required) or Spare Part (no CE)
  81. Is CE Re-Certification Necessary? - Add internal cooling fan
  82. ENEC Mark - How is it related to the CE Mark and is it Compulsory?
  83. CE Marking Current Status with MOD
  84. Medical Device or not - Throat lozenge
  85. CE Mark Size Requirement - Class I Medical Device
  86. CE for assembled products based on OEM which has its own CE
  87. Lot numbers in Declaration of Conformity
  88. Non CE marked medical devices /clinical investigation
  89. Vigilance Report Required for Incidents Outside the EU?
  90. Is CE Mark required for Hand Sanitizers to be sold in Europe ?
  91. Technical Agreement for the CE Mark - Essential Requirements Checklist
  92. Flame Class for Enclosure of Medical Equipment
  93. Certificate of Conformity? Supplier incoming material inspection
  94. CE Marking for Baby Crib Mattress - Which Directive? Is self declaration enough?
  95. CE marking - Annex V vs Annex II
  96. Technical file for Software that's merely an interface for doctor to visualize data
  97. IEC 60601-1 3rd Edition Recognition in Canada