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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. Getting CE Mark - What is the process of getting it?
  7. What's the gap between CE-marking and FDA's approval?
  8. CE Mark & Harmonized Standards - Article 5.1, MDD - Has anyone challanged this?
  9. CE Marking for Class I Medical Devices - Self-declare CE marking?
  10. CE Mark Medical Devices - Annexes II, IV, V and VI
  11. CE Mark - FDA - Class I traction systems - What is involved and how long does it take
  12. CE Mark "piggybacking" on suppliers technical files - Looking for contract example
  13. CE marking - Medical Device - Must have our name and address on it?
  14. CE Marking Question - Class IIa device by complying with Annex V & VII
  15. CE Marking for Power Supply for Medical Device - Class IIb device per MDD, Rule 11
  16. CE Mark Question, Manufactuerer or distributor, steps the same?
  17. CE mark - Trying to determine if our product needs CE approval
  18. CE Mark & Harmonized Standards
  19. Obtaining the CE Mark from TUV
  20. CE marking, required for prototypes? New technology lighting source
  21. MDD and CE Mark Registration - What will the technical expert look for?
  22. CE Mark Database akin to 510 (k) database?
  23. Instructions for Use - Ob/Gyn products sold in Europe - CE mark and the NB number
  24. Technical File for CE declaration - Template or Sample of required contents
  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. Application of ISO 14155 Clinical Trials Investigations
  36. Preparing the Technical File for a 12 Lead ECG Monitor
  37. Requirements for Updating a Medical Device Technical File
  38. A need for CE Marking? Structural Steel
  39. MDD confomity assessment - ISO 13485 registration counts for nothing???
  40. Comparison of ISO 14155 to FDA Good Clinical Practice
  41. CE Marking MDD & EN 980 Labeling Requirements, IFU, Packaging, etc.
  42. The status of the 2005 ammendments to the MDD (Medical Device Directive)?
  43. GMDN (Global Medical Device Nomenclature) Codes
  44. New List of Medical Device Harmonized Standards - MDD
  45. CE-Mark for Ceramic Tiles
  46. International Symbols in Metrology and Calibration
  47. Requirements for Declaration of Conformity - Compliance to MDD
  48. Which Harmonized Standard to which Essential Requirement
  49. CE Marking Issue- this seems illegal to me...
  50. Revision of MDD 93/42/EEC, AIMD 90/385/EEC and BPD 98/8/EC published: 2007/47/EC
  51. Requirements for CE marking a component to go into an assembly (PED)
  52. CE Mark for Surgical Gowns & Surgical Drapes
  53. Medical Device (MedDev) Vigilance Guidelines for Importers into the UE
  54. MDD for Drug Product for CE Marking
  55. Multiple Applied Parts - Cardiac Floating (CF), Body Floating (BF) Marking
  56. What is the Process for CE Marking a Flight Simulator
  57. CE Marking Specific Discussion or Forum Web Sites
  58. Minimizing cost of product certification - int/ext CE certified Powersupply Unit?
  59. Active Medical Devices - An example of an Active Medical Device and Definition
  60. CE Mark / TCF (Technical Construction File) File sample
  61. New MDD Consolidated Version Published
  62. Declaration of Conformity - Conformance with more than one directive
  63. CE mark for photo frames albums for UK
  64. Experience with IMB as Competent Authority of Drug Device Combination Products?
  65. CB (Certification Body /Competent Body) and CE (European Mark of Conformity)?
  66. CE Marking outside of Europe?
  67. Independent authorized CE Marking representative in UK or EU - Class 1 Medical Device
  68. Medical Device Vigilance System Requirements - CE Mark Products
  69. CE marking of products - How do you know if your product requires it?
  70. Implications on the Legal Status of the "Declaration of Conformity"
  71. CE Mark Requirements for Dentist Chair
  72. Sales in Europe of CE marked Medical devices with sister company
  73. Finally! CE Mark capable in construction products
  74. CE Marking Process - Obligations of an Authorized Representative
  75. Medical Products: CE Marking - Are the DMR's, Technical Files, DHF, required?
  76. PED (Pressure Equipment Directive) Certification - We hold an ASME 'S' stamp
  77. Comparison between MDD and AIMD
  78. Accessory (CE required) or Spare Part (no CE)
  79. Is CE Re-Certification Necessary? - Add internal cooling fan
  80. ENEC Mark - How is it related to the CE Mark and is it Compulsory?
  81. CE Marking Current Status with MOD
  82. Medical Device or not - Throat lozenge
  83. CE Mark Size Requirement - Class I Medical Device
  84. CE for assembled products based on OEM which has its own CE
  85. Lot numbers in Declaration of Conformity
  86. EU Vigilance (updated MEDDEV rev.5) - Internal Forms
  87. Non CE marked medical devices /clinical investigation
  88. Vigilance Report Required for Incidents Outside the EU?
  89. Is CE Mark required for Hand Sanitizers to be sold in Europe ?
  90. Technical Agreement for the CE Mark - Essential Requirements Checklist
  91. Flame Class for Enclosure of Medical Equipment
  92. Certificate of Conformity? Supplier incoming material inspection
  93. CE Marking for Baby Crib Mattress - Which Directive? Is self declaration enough?
  94. CE marking - Annex V vs Annex II
  95. Technical file for Software that's merely an interface for doctor to visualize data
  96. CE for different products
  97. CE marking with or without NB (Notified Body)
  98. Low Voltage Directive 2006/95/EC - Is Notified Body (NB) needed?
  99. CE Mark - Timber/Wood Working Equipment
  100. Medical Device "accessory" - Blood pressure monitor (BPM) power supply
  101. Sterilization of Implantable bone screws - ISO 13485 and CE Mark
  102. CE Marking for Research Instruments - Small Company - Class II Medical Device
  103. On/OFF switch received from supplier - No CE marking but with Certificate
  104. CE Marking for Wood Product - One for each product?, Self Declare?
  105. Device Classification Issue - Pacemaker, pacemaker lead and pacemaker programmer
  106. Advice Please regarding CE Marking requirements for Printing Press
  107. LCD-TFT screen with player for publicity film - Commercial device CE Marking
  108. Is CE marking required for power resistors?
  109. IFU (Instructions for Use) - Labeling Requirements
  110. CE Marking regulation of construction products starting on January 2009
  111. Medical Device Directive, Conversion from class IIb to class III
  112. Who can do a noise emission test for us?
  113. New Harmonized Standards MDD and IVDD
  114. CE marking on medical device components/replacement parts
  115. Use of Phthalates (PVC) - MDD 2007/47/EC - Has anyone started labelling devices
  116. Particulate Release Testing on Catheters
  117. CE Marking based on components CE
  118. Serial Number labeling for Class IIa Medical device packaged in multi-pack
  119. Establishing a biocompability test lab for testing EN 10993 series
  120. Looking for Authorized Representative to host our technical files in Europe
  121. Procedure for Declaration of Conformity
  122. IFU - Refer the end user to the outer labeling of a CE Marked Class IIa device
  123. Loss of CE Mark - MHRA decided that they are not Medical Devices
  124. MDD 93/42/EEC and Leather - CE-marking our (class I) product
  125. CE Marking for Sterile and Non-sterile device - Surgical blades
  126. Material standards for med-tech gloves
  127. Biocompatibility test for absorbable ophthalmic suture
  128. Notified Body References and Reviews - Changing ISO 13485 Registrars
  129. CE Mark Testing - Getting quotes is frustrating
  130. Minimum requirements for immediate package
  131. Hot water cylinder parts - Testing per the Low Voltage Directive
  132. LVD (Low Voltage Directive) - Wiring instructions for the end user
  133. Class I medical Device with CE Certificate - Certificate issued by a 3rd party?
  134. How much fees should I prepare for the TGA certificate
  135. Where to CE Mark a Class I medical device the size of a small tablet
  136. Shipping Non-CE products to EU for exporting to other countries
  137. Labeling of Devices - MDD to label both pouches of a sterile device
  138. MDD Definition of Address as it applies to Medical Device Labeling
  139. Changes in a product with CE mark - Directive Low Voltage
  140. EU Directive 98/37/EC - Machine Safety, any expierence?
  141. Single Multifunction device CE approval - Medical and non-medical
  142. European Translation Requirements - English to German - Medical Device User Manuals
  143. MDD 2007 single-use device, include risk of re-use in IFU
  144. CE Marking - Is self-certification OK?
  145. CE Mark - What is the meaning of CE or CE0050(text inserted here)
  146. CE Product Registration Bar Codes for each Product - Anyone?
  147. CE Mark using Registered Trademark to identify the legal manufacturer
  148. CE Marking - Medical Devices - Clinical Evaluation to 2007/47/EC
  149. CE Certification for Secure Computing/Tempest company
  150. Consequences of Shipping product with label not following CE rules
  151. Relation between 93/42/EEC and 2007/47/EC
  152. New MDD requirements & Software Interface
  153. Spinal Needle & Epidural Anaesthesia Kits Classification - IIb or III?
  154. EU Medical Device Regulations - Summary Report
  155. Essential info on the name place of a CE marked medical product
  156. Device Subcategory and Generic Device Group differences
  157. Technical File Review to updated MDD 93/42/EC (Class II medical devices)
  158. Containment Device Classification - Class I Medical Device via Rule 1 MDD Annex IX
  159. Multisite CE certificate - Class IIB medical devices per MDD Annex 2
  160. CE Mark - Technical File Help - Machinery Directive 98/37/ec
  161. EU Representative Requirements - Class IIa devices manufacturer
  162. CE Marking for PCB Components for Laser Printer Cartridges
  163. CE Class of Spinal needle under DIRECTIVE 2007/47/EC
  164. Clinical Evaluation using the Literature Method - Example or information wanted
  165. Is it weird for my conducted immunity (4-6) test result? Need help.
  166. Registration Requirements for Class I Medical Devices in EU?
  167. Tailor-made or Custom Made Device?
  168. How Directive 2007/47/EEC will affect Medical Devices industries?
  169. Roadmap for Clinical Trial for Orthopaedic Medical Devices
  170. Declaration of Conformity - New directive, new declaration
  171. Requirements for Exporting from US to EU - Class I MD non-sterile, non-measuring
  172. CE Mark on Promotional Material (Brochure for our Medical Device)
  173. New Requirements for Fixed Machine Guarding - Fasteners
  174. Sterile Product Ship Testing (Medical Device Packaging)
  175. Technical File - Own Brand Labeling Requirements
  176. Accessories or Spare Parts need CE MARK? Breast Pump Feed Containers
  177. RoHs and Weee Requirements for a planned market launch in 2010
  178. MHRA - Draft guidance on specific device vigilance reporting
  179. Change of classification according to amendment directive 2007/47
  180. Revised list of harmonized standards for medical device directives in the EU
  181. Labeling Requirements for Reusable Class II Medical Device in the EU
  182. CE Mark and NB Identification Number Location
  183. Understanding Directive 2007/47/EC - SOP & Checklist needed
  184. CE Mark for Dental Imaging Software
  185. CE Marking for Electromagnetic Clutch and Brakes
  186. EN 1041 or EN 980 - Need Documents Please!
  187. Is there any Government Grant for CE marking? (India)
  188. Revisions to the MDD 93/42/EEC published as Directive 2007/47/EC
  189. Technical File Submission? - Medical Devices no longer made
  190. Validity of NB-MEDs (MDD / CE marking)
  191. Which directives? CE marking for some of our in-house products
  192. Technical File Format - MEDDEV 2.5.1
  193. Classification of Dental Implants - MDD 2.4. Rule 8
  194. Declaration of Conformity - Updating the DofC to MMD 2007/47/EC
  195. Export Ambulance CAR to EU country - which EU directive is applicable?
  196. What's the classification for Blood Lancet in India, Indonesia, Malaysia and Pakistan
  197. Lisbon customs requires for MDD declaration of conformity?
  198. Are the power cables to be CE marked? IVD instrument
  199. MDD and Mandatory Standards (IEC/EN 60601-1-4, 60601-1-6 and ISO 14971)
  200. Notified Body on Class I Declaration of Conformity?
  201. Spanish Customs Claim: Has the MDD class to be mentioned in the DoC?
  202. Standard Version(s) on Declaration of Conformity (DoC) - Necessary or required?