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Public consultation on the In Vitro Diagnostic medical device Directive

Individual responses  

 

 1. AdvaMed 1pdf - AdvaMed 2pdf

2. AdvaQaRapdf

3. Asper Biotech Ltdpdf

4. Association des Cytogénéticiens de Langue Françaisepdf

5. Association for Clinical Biochemistrypdf

6. Association for Clinical Biochemistry cytogeneticspdf

7. Association for Quality Management in Laboratory Medicinepdf

8. Ataxia UKpdf

9. Austria - Federal Ministry of Healthpdf

10. Bactus ABpdf

11. Barts and the London NHS Trust, London, UKpdf

12. Belgium - Institut scientifique de Santé Publiquepdf

13. Berufsvereinigung der Naturwissenschaftler in der Labordiagnostikpdf

14. Bristol Genetics Laboratory, North Bristol NHS Trust, Bristolpdf

15. British In Vitro Diagnostics Associationpdf

16. British Society of Human geneticspdf

17. BSI 1pdfBSI 2pdf

18. Cancer Research UKpdf

19. CEN CENELECpdf

20. Cepheidpdf

21. CLIMBpdf

22. Clinical Genetic Society of Croatiapdf

23. Clinical Genetics Units – Swedenpdf

24. Clinical Molecular Genetics Societypdf

25. College of Medical Genetics of the Portuguese Medical Associationpdf

26. Comitato Nazionale per la Biosicurezza e le Biotecnologie e le Scienze della Vitapdf

27. Croatian Society of Human Geneticspdf

28. Czech Republic - Ministry of Healthpdf

29. Czech Society of Human Geneticspdf

30. Danish Medical Societypdf

31. Danish Society for Clinical Biochemistrypdf

32. Denmark - Ministry of Interior and Healthpdf

33. Department of Clinical Engineering, Central Denmark Regionpdf

34. Department of Genetics, Tartu University Hospital, Estoniapdf

35. Department of Pediatrics, University Hospital Motol, Praha, Czech Republicpdf

36. Dept. Clinical Biochemistry, Aarhus University Hospital, Denmarkpdf

37. Dept. of Laboratory Medicine of St Imre Hospital, Budapestpdf

38. Dept. of Laboratory Medicine, Greater Glasgow & Clyde NHS Trust, Glasgowpdf

39. Dept. of Molecular Medicine, Aarhus University Hospital, Denmarkpdf

40. Deutsche Krankenhausgesellschaftpdf

41. Deutsche Sozialversicherungpdf

42. Deutschen Gesellschaft für Hygiene und Mikrobiologiepdf

43. Deutschen Vereinigung zur Bekämpfung der Viruskrank-heitenpdf

44. Dpt of laboratory Medicine, Lothian University Hospital, Edinburghpdf

45. Dr. Dietmar Stöckl, Belgiumpdf

46. Dutch Society of Clinical Genetic Diagnostic Laboratoriespdf

47. Dutch Society of Clinical Geneticspdf

48. Entreprise Europe Poitou Charentespdf

49. EUROCAT BSIpdf

50. Eurogentestpdf

51. European Biopharmaceutical Enterprisespdf

52. European Centre for Disease Prevention and Controlpdf

53. European Diagnostics Manufacturers Assosiationpdf

54. European Federation of Clinical Chemistrypdf

55. European Genetic Alliances' Networkpdf

56. European Hospital and Healthcare Federationpdf

57. European Society for Clinical Microbiology and Infectious Diseasespdf

58. European Society of Human Geneticspdf

59. European Society of Pathologypdf

60. European Union of Medical Specialistpdf

61. Exonhit Therapeuticspdf

62. Fédération Nationale des Centres de Lutte Contre le Cancerpdf

63. Finnish Society for medical geneticspdf

64. France - Ministry of Healthpdf

65. French Federation of Human Geneticspdf

66. Genetic and Rare Disorders Organisationpdf

67. Genetic center, Guy’s Hospital, Londonpdf

68. Genetics Laboratories - Guy's Hospital – UKpdf

69. Génétique Oncologique - Institut Curie – Parispdf

70. GeneWatch UKpdf

71. Genzymepdf

72. German Notified Bodies Alliance VdTUVpdf

73. German Society for Clinical Chemistry and Laboratory Medicinepdf

74. German Society of Human Geneticspdf

75. Germany - Bundesministerium für Gesundheitpdf

76. Glen Paul Freiberg, USApdf

77. Haematological cytogenetics - CHU St Etienne – Francepdf

78. Health Protection Agencypdf

79. Hellenic Association of Medical Geneticistspdf

80. Hungarian Society of Human Geneticspdf

81. Hungary - Health administrationpdf

82. Huntington’s Disease Association Irelandpdf

83. Institute of Biomedical Sciencepdf

84. Integragenpdf

85. Intergen Genetics Centre - Ankara – Turkeypdf

86. International Federation of Clinical Chemistry and Laboratory Medicinepdf

87. IPSOGENpdf

88. Irish blood transfucion servicepdf

89. Irish Medical devices associationpdf

90. Irish Medicines Boardpdf

91. Irish National Centre for Medical Geneticspdf

92. Irish Society of Human Geneticspdf

93. Italian Society of Human Geneticspdf

94. Johnson&Johnsonpdf

95. Joint Committee for Traceability in Laboratorypdf

96. KEMA Quality B.Vpdf

97. Laboratory Corporation of Americapdf

98. Laboratory for Analytical Chemistry, Gent, Belgiumpdf

99. Laboratory of Genetic Medicine - Nancy – Francepdf

100. Latvian Medical Genetics Associationpdf

101. LNE G-Med NBpdf

102. LRQA NBpdf

103. MetBioNetpdf

104. Molecular Genetics laboratory of the Northern Genetics Servicepdf

105. mosaiques-diagnosticspdf

106. Muscular Dystrophy Irelandpdf

107. National Institute for Biological Standards and Controlpdf

108. Netherland - Dutch competent authoritypdf

109. Netherlands Society for Clinical Chemistry and laboratory medicinepdf

110. Neurogenetics unit - Pitie-Salpetriere - AP-HPpdf

111. NHS Blood and Transplant, Birminghampdf

112. NHS Blood and Transplant, Brentwood, Essexpdf

113. NHS Blood and Transplant, Bristolpdf

114. NHS Blood and Transplant, Cambridgepdf

115. NHS Blood and Transplant, Southamptonpdf

116. NHS European officepdf

117. NHS National services Scotlandpdf

118. NHSBT Histocompatibility & Immunogenetics Laboratoriespdf

119. North East Thames Regional Genetics Service, Londonpdf

120. North West Thames Regional Genetics Service, Harrowpdf

121. Norwegian Directorate of Healthpdf

122. Notified Body – IVD – Working Group’pdf

123. Paul Ehrlich Institutpdf

124. PHG Foundationpdf

125. Point of Care Consultative Group – Irelandpdf

126. Portugal - National Authority of Medicines and Health Productspdf

127. Portuguese Society of Human Geneticspdf

128. Prof. Dr. Ulrich Sack, Leipzigpdf

129. Robyn Wood, Bougival, Francepdf

130. Rochepdf

131. Royal Hospital for Sick Children, Glasgow, UKpdf

132. Sanquin Diagnostic Servicespdf

133. Saudi Food and Drug Authoritypdf

134. Scottish Clinical Biochemistry Managed Diagnostic Networkpdf

135. Scottish Microbiology Forumpdf

136. Scottish Regional Council of The Royal College of Pathologistspdf

137. SFL Regulatory Affairs & Scientific Communication Ltdpdf

138. SGS United Kingdom Ltd, Notified Bodypdf

139. Société Française de Génétique Humainepdf

140. Spanish Competent Authorities – Aempspdf

141. Spanish Society of Human Geneticspdf

142. St James's University Hospital, Leeds, UKpdf

143. Standing Committee of European Doctorspdf

144. State Institute for Drug Control, Praha, Czech Republicpdf

145. Sweden - Medical Product Agencypdf

146. Swedish Society of Medical Geneticspdf

147. Swedish Society of Medicinepdf

148. Swiss Agency for Therapeutic Productspdf

149. Team-NB associationpdf

150. TÜV Rheinland LGA Products GmbHpdf

151. TÜV SUD AGpdf

152. TÜV SÜD Product Service GmbHpdf

153. UK department of Health's advisory ARHAIpdf

154. UK Genetic testing Networkpdf

155. UK Joint Committee on Medical Geneticspdf

156. UK Newborn Screening Laboratories Networkpdf

157. UK Royal College of Pathologistspdf

158. UL International UK Ltdpdf

159. VAD parrallel Distributorpdf

160. Verband der Diagnostica-Industrie VDGHpdf

161. Whichpdf