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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 Medical Device 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 in construction products
  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
  98. CE for different products
  99. New edition of IEC 60601-1 - Risk assessment to determine the liquid - 11.6.3
  100. CE marking with or without NB (Notified Body)
  101. Low Voltage Directive 2006/95/EC - Is Notified Body (NB) needed?
  102. Relationship of IEC 60601-1-6:2006 vs. IEC 60601-1 3rd Edition
  103. Usability Engineering File - Looking for an example/template
  104. CE Mark - Timber/Wood Working Equipment
  105. Medical Device "accessory" - Blood pressure monitor (BPM) power supply
  106. Sterilization of Implantable bone screws - ISO 13485 and CE Mark
  107. CE Marking for Research Instruments - Small Company - Class II Medical Device
  108. On/OFF switch received from supplier - No CE marking but with Certificate
  109. CE Marking for Wood Product - One for each product?, Self Declare?
  110. Device Classification Issue - Pacemaker, pacemaker lead and pacemaker programmer
  111. Advice Please regarding CE Marking requirements for Printing Press
  112. LCD-TFT screen with player for publicity film - Commercial device CE Marking
  113. Is CE marking required for power resistors?
  114. IFU (Instructions for Use) - Labeling Requirements
  115. CE Marking regulation of construction products starting on January 2009
  116. Medical Device Directive, Conversion from class IIb to class III
  117. Who can do a noise emission test for us?
  118. New Harmonized Standards MDD and IVDD
  119. CE marking on medical device components/replacement parts
  120. Biocompatibility - Hospital Bed
  121. Use of phthalates - MDD 2007/47/EC
  122. Particulate Release Testing on Catheters
  123. Usability Engineering ISO 62366:2008 - Medical Devices
  124. CE Marking based on components CE
  125. Serial Number labeling for Class IIa Medical device packaged in multi-pack
  126. Establishing a biocompability test lab for testing EN 10993 series
  127. Looking for Authorized Representative to host our technical files in Europe
  128. Procedure for Declaration of Conformity
  129. IFU - Refer the end user to the outer labeling of a CE Marked Class IIa device
  130. Loss of CE Mark - MHRA decided that they are not Medical Devices
  131. MDD 93/42/EEC and Leather - CE-marking our (class I) product
  132. CE Marking for Sterile and Non-sterile device - Surgical blades
  133. Material standards for med-tech gloves
  134. Biocompatibility test for absorbable ophthalmic suture
  135. CE Mark Testing - Getting quotes is frustrating
  136. Minimum requirements for immediate package
  137. Hot water cylinder parts - Testing per the Low Voltage Directive
  138. LVD (Low Voltage Directive) - Wiring instructions for the end user
  139. Class I medical Device with CE Certificate - Certificate issued by a 3rd party?
  140. How much fees should I prepare for the TGA certificate
  141. Where to CE Mark a Class I medical device the size of a small tablet
  142. Shipping Non-CE products to EU for exporting to other countries
  143. Changes in a product with CE mark - Directive Low Voltage
  144. EU Directive 98/37/EC - Machine Safety, any expierence?
  145. Single Multifunction device CE approval - Medical and non-medical
  146. European Translation Requirements - English to German - Medical Device User Manuals
  147. MDD 2007 single-use device, include risk of re-use in IFU
  148. CE Marking - Is self-certification OK?
  149. CE Mark - What is the meaning of CE or CE0050(text inserted here)
  150. CE Product Registration Bar Codes for each Product - Anyone?
  151. CE Mark using Registered Trademark to identify the legal manufacturer
  152. CE Marking - Medical Devices - Clinical Evaluation to 2007/47/EC
  153. CE Certification for secure computing/tempest company
  154. Consequences of Shipping product with label not following CE rules
  155. Relation between 93/42/EEc and 2007/47/EC
  156. New MDD requirements & Software Interface