Public consultation on the In Vitro Diagnostic medical device Directive

Individual responses  

 1. AdvaMed 1 Choose translations of the previous link français (fr) - AdvaMed 2 Choose translations of the previous link français (fr)

2. AdvaQaRapdf(18 KB)

3. Asper Biotech Ltdpdf(7 KB)

4. Association des Cytogénéticiens de Langue Françaisepdf(205 KB)

5. Association for Clinical Biochemistrypdf(75 KB)

6. Association for Clinical Biochemistry cytogeneticspdf(54 KB)

7. Association for Quality Management in Laboratory Medicinepdf(165 KB)

8. Ataxia UKpdf(35 KB)

9. Austria - Federal Ministry of Healthpdf(190 KB)

10. Bactus ABpdf(19 KB)

11. Barts and the London NHS Trust, London, UKpdf(10 KB)

12. Belgium - Institut scientifique de Santé Publiquepdf(369 KB)

13. Berufsvereinigung der Naturwissenschaftler in der Labordiagnostik Choose translations of the previous link Deutsch (de)

14. Bristol Genetics Laboratory, North Bristol NHS Trust, Bristolpdf(19 KB)

15. British In Vitro Diagnostics Associationpdf(54 KB)

16. British Society of Human geneticspdf(54 KB)

17. BSI 1pdf(63 KB)BSI 2pdf(45 KB)

18. Cancer Research UKpdf(123 KB)

19. CEN CENELECpdf(35 KB)

20. Cepheidpdf(112 KB)

21. CLIMBpdf(530 KB)

22. Clinical Genetic Society of Croatiapdf(150 KB)

23. Clinical Genetics Units – Swedenpdf(56 KB)

24. Clinical Molecular Genetics Societypdf(56 KB)

25. College of Medical Genetics of the Portuguese Medical Associationpdf(9 KB)

26. Comitato Nazionale per la Biosicurezza e le Biotecnologie e le Scienze della Vitapdf(2 MB)

27. Croatian Society of Human Geneticspdf(96 KB)

28. Czech Republic - Ministry of Healthpdf(46 KB)

29. Czech Society of Human Geneticspdf(36 KB)

30. Danish Medical Societypdf(69 KB)

31. Danish Society for Clinical Biochemistrypdf(67 KB)

32. Denmark - Ministry of Interior and Healthpdf(892 KB)

33. Department of Clinical Engineering, Central Denmark Regionpdf(33 KB)

34. Department of Genetics, Tartu University Hospital, Estoniapdf(9 KB)

35. Department of Pediatrics, University Hospital Motol, Praha, Czech Republicpdf(8 KB)

36. Dept. Clinical Biochemistry, Aarhus University Hospital, Denmarkpdf(34 KB)

37. Dept. of Laboratory Medicine of St Imre Hospital, Budapestpdf(45 KB)

38. Dept. of Laboratory Medicine, Greater Glasgow & Clyde NHS Trust, Glasgowpdf(203 KB)

39. Dept. of Molecular Medicine, Aarhus University Hospital, Denmarkpdf(441 KB)

40. Deutsche Krankenhausgesellschaftpdf(777 KB)

41. Deutsche Sozialversicherungpdf(203 KB)

42. Deutschen Gesellschaft für Hygiene und Mikrobiologiepdf(65 KB)

43. Deutschen Vereinigung zur Bekämpfung der Viruskrank-heitenpdf(180 KB)

44. Dpt of laboratory Medicine, Lothian University Hospital, Edinburghpdf(36 KB)

45. Dr. Dietmar Stöckl, Belgiumpdf(10 KB)

46. Dutch Society of Clinical Genetic Diagnostic Laboratoriespdf(40 KB)

47. Dutch Society of Clinical Geneticspdf(50 KB)

48. Entreprise Europe Poitou Charentespdf(185 KB)

49. EUROCAT BSIpdf(308 KB)

50. Eurogentestpdf(220 KB)

51. European Biopharmaceutical Enterprisespdf(41 KB)

52. European Centre for Disease Prevention and Controlpdf(143 KB)

53. European Diagnostics Manufacturers Assosiationpdf(156 KB)

54. European Federation of Clinical Chemistrypdf(93 KB)

55. European Genetic Alliances' Networkpdf(94 KB)

56. European Hospital and Healthcare Federationpdf(52 KB)

57. European Society for Clinical Microbiology and Infectious Diseasespdf(48 KB)

58. European Society of Human Geneticspdf(353 KB)

59. European Society of Pathologypdf(29 KB)

60. European Union of Medical Specialistpdf(55 KB)

61. Exonhit Therapeutics Choose translations of the previous link français (fr)

62. Fédération Nationale des Centres de Lutte Contre le Cancerpdf(227 KB)

63. Finnish Society for medical geneticspdf(217 KB)

64. France - Ministry of Health Choose translations of the previous link français (fr)

65. French Federation of Human Genetics Choose translations of the previous link français (fr)

66. Genetic and Rare Disorders Organisationpdf(25 KB)

67. Genetic center, Guy’s Hospital, Londonpdf(56 KB)

68. Genetics Laboratories - Guy's Hospital – UKpdf(31 KB)

69. Génétique Oncologique - Institut Curie – Parispdf(14 KB)

70. GeneWatch UKpdf(73 KB)

71. Genzymepdf(903 KB)

72. German Notified Bodies Alliance VdTUVpdf(308 KB)

73. German Society for Clinical Chemistry and Laboratory Medicine  Document 1pdf(50 KB) and Document 2pdf(71 KB)

74. German Society of Human Geneticspdf(41 KB)

75. Germany - Bundesministerium für Gesundheit Choose translations of the previous link Deutsch (de)

76. Glen Paul Freiberg, USApdf(48 KB)

77. Haematological cytogenetics - CHU St Etienne – Francepdf(14 KB)

78. Health Protection Agencypdf(90 KB)

79. Hellenic Association of Medical Geneticistspdf(35 KB)

80. Hungarian Society of Human Geneticspdf(2 MB)

81. Hungary - Health administrationpdf(129 KB)

82. Huntington’s Disease Association Irelandpdf(2 MB)

83. Institute of Biomedical Sciencepdf(558 KB)

84. Integragenpdf(38 KB)

85. Intergen Genetics Centre - Ankara – Turkeypdf(84 KB)

86. International Federation of Clinical Chemistry and Laboratory Medicinepdf(38 KB)

87. IPSOGENpdf(30 KB)

88. Irish blood transfucion servicepdf(16 KB)

89. Irish Medical devices associationpdf(82 KB)

90. Irish Medicines Boardpdf(91 KB)

91. Irish National Centre for Medical Geneticspdf(16 KB)

92. Irish Society of Human Geneticspdf(80 KB)

93. Italian Society of Human Geneticspdf(14 KB)

94. Johnson&Johnsonpdf(83 KB)

95. Joint Committee for Traceability in Laboratorypdf(366 KB)

96. KEMA Quality B.Vpdf(80 KB)

97. Laboratory Corporation of Americapdf(410 KB)

98. Laboratory for Analytical Chemistry, Gent, Belgiumpdf(14 KB)

99. Laboratory of Genetic Medicine - Nancy – Francepdf(8 KB)

100. Latvian Medical Genetics Associationpdf(107 KB)

101. LNE G-Med NBpdf(63 KB)

102. LRQA NBpdf(66 KB)

103. MetBioNetpdf(20 KB)

104. Molecular Genetics laboratory of the Northern Genetics Service Choose translations of the previous link français (fr)

105. mosaiques-diagnostics Choose translations of the previous link Deutsch (de)

106. Muscular Dystrophy Irelandpdf(20 KB)

107. National Institute for Biological Standards and Controlpdf(111 KB)

108. Netherland - Dutch competent authoritypdf(148 KB)

109. Netherlands Society for Clinical Chemistry and laboratory medicinepdf(61 KB)

110. Neurogenetics unit - Pitie-Salpetriere - AP-HPpdf(14 KB)

111. NHS Blood and Transplant, Birminghampdf(404 KB)

112. NHS Blood and Transplant, Brentwood, Essexpdf(36 KB)

113. NHS Blood and Transplant, Bristolpdf(884 KB)

114. NHS Blood and Transplant, Cambridgepdf(42 KB)

115. NHS Blood and Transplant, Southamptonpdf(43 KB)

116. NHS European officepdf(174 KB)

117. NHS National services Scotlandpdf(2 MB)

118. NHSBT Histocompatibility & Immunogenetics Laboratoriespdf(345 KB)

119. North East Thames Regional Genetics Service, Londonpdf(60 KB)

120. North West Thames Regional Genetics Service, Harrowpdf(11 KB)

121. Norwegian Directorate of Healthpdf(786 KB)

122. Notified Body – IVD – Working Group’pdf(63 KB)

123. Paul Ehrlich Institutpdf(69 KB)

124. PHG Foundationpdf(194 KB)

125. Point of Care Consultative Group – Irelandpdf(25 KB)

126. Portugal - National Authority of Medicines and Health Productspdf(31 KB)

127. Portuguese Society of Human Geneticspdf(7 KB)

128. Prof. Dr. Ulrich Sack, Leipzigpdf(9 KB)

129. Robyn Wood, Bougival, Francepdf(29 KB)

130. Rochepdf(200 KB)

131. Royal Hospital for Sick Children, Glasgow, UKpdf(283 KB)

132. Sanquin Diagnostic Servicespdf(667 KB)

133. Saudi Food and Drug Authoritypdf(61 KB)

134. Scottish Clinical Biochemistry Managed Diagnostic Networkpdf(61 KB)

135. Scottish Microbiology Forumpdf(59 KB)

136. Scottish Regional Council of The Royal College of Pathologistspdf(67 KB)

137. SFL Regulatory Affairs & Scientific Communication Ltdpdf(60 KB)

138. SGS United Kingdom Ltd, Notified Bodypdf(52 KB)

139. Société Française de Génétique Humainepdf(8 KB)

140. Spanish Competent Authorities – Aemps Choose translations of the previous link español (es)

141. Spanish Society of Human Geneticspdf(13 KB)

142. St James's University Hospital, Leeds, UKpdf(286 KB)

143. Standing Committee of European Doctorspdf(112 KB)

144. State Institute for Drug Control, Praha, Czech Republicpdf(52 KB)

145. Sweden - Medical Product Agencypdf(172 KB)

146. Swedish Society of Medical Geneticspdf(205 KB)

147. Swedish Society of Medicinepdf(191 KB)

148. Swiss Agency for Therapeutic Productspdf(56 KB)

149. Team-NB associationpdf(69 KB)

150. TÜV Rheinland LGA Products GmbHpdf(2 MB)

151. TÜV SUD AGpdf(356 KB)

152. TÜV SÜD Product Service GmbHpdf(356 KB)

153. UK department of Health's advisory ARHAIpdf(89 KB)

154. UK Genetic testing Networkpdf(39 KB)

155. UK Joint Committee on Medical Geneticspdf(184 KB)

156. UK Newborn Screening Laboratories Networkpdf(16 KB)

157. UK Royal College of Pathologistspdf(205 KB)

158. UL International UK Ltdpdf(150 KB)

159. VAD parrallel Distributorpdf(183 KB)

160. Verband der Diagnostica-Industrie VDGHpdf(81 KB)

161. Whichpdf(128 KB)