Public consultation on the In Vitro Diagnostic medical device Directive

Individual responses  

 

 1. AdvaMed 1  français (fr) - AdvaMed 2  français (fr)

2. AdvaQaRa(18 KB)

3. Asper Biotech Ltd(7 KB)

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

5. Association for Clinical Biochemistry(75 KB)

6. Association for Clinical Biochemistry cytogenetics(54 KB)

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

8. Ataxia UK(35 KB)

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

10. Bactus AB(19 KB)

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

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

13. Berufsvereinigung der Naturwissenschaftler in der Labordiagnostik

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

15. British In Vitro Diagnostics Association(54 KB)

16. British Society of Human genetics(54 KB)

17. BSI 1(63 KB) -  BSI 2(45 KB)

18. Cancer Research UK(123 KB)

19. CEN CENELEC(35 KB)

20. Cepheid(112 KB)

21. CLIMB(530 KB)

22. Clinical Genetic Society of Croatia(150 KB)

23. Clinical Genetics Units – Sweden(56 KB)

24. Clinical Molecular Genetics Society(56 KB)

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

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

27. Croatian Society of Human Genetics(96 KB)

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

29. Czech Society of Human Genetics(36 KB)

30. Danish Medical Society(69 KB)

31. Danish Society for Clinical Biochemistry(67 KB)

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

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

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

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

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

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

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

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

40. Deutsche Krankenhausgesellschaft(777 KB)

41. Deutsche Sozialversicherung(203 KB)

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

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

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

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

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

47. Dutch Society of Clinical Genetics(50 KB)

48. Entreprise Europe Poitou Charentes(185 KB)

49. EUROCAT BSI(308 KB)

50. Eurogentest(220 KB)

51. European Biopharmaceutical Enterprises(41 KB)

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

53. European Diagnostics Manufacturers Assosiation(156 KB)

54. European Federation of Clinical Chemistry(93 KB)

55. European Genetic Alliances' Network(94 KB)

56. European Hospital and Healthcare Federation(52 KB)

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

58. European Society of Human Genetics(353 KB)

59. European Society of Pathology(29 KB)

60. European Union of Medical Specialist(55 KB)

61. Exonhit Therapeutics  français (fr)

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

63. Finnish Society for medical genetics(217 KB)

64. France - Ministry of Health  français (fr)

65. French Federation of Human Genetics  français (fr)

66. Genetic and Rare Disorders Organisation(25 KB)

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

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

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

70. GeneWatch UK(73 KB)

71. Genzyme(903 KB)

72. German Notified Bodies Alliance VdTUV(308 KB)

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

74. German Society of Human Genetics(41 KB)

75. Germany - Bundesministerium für Gesundheit  Deutsch (de)

76. Glen Paul Freiberg, USA(48 KB)

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

78. Health Protection Agency(90 KB)

79. Hellenic Association of Medical Geneticists(35 KB)

80. Hungarian Society of Human Genetics(2 MB)

81. Hungary - Health administration(129 KB)

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

83. Institute of Biomedical Science(558 KB)

84. Integragen(38 KB)

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

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

87. IPSOGEN(30 KB)

88. Irish blood transfucion service(16 KB)

89. Irish Medical devices association(82 KB)

90. Irish Medicines Board(91 KB)

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

92. Irish Society of Human Genetics(80 KB)

93. Italian Society of Human Genetics(14 KB)

94. Johnson&Johnson(83 KB)

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

96. KEMA Quality B.V(80 KB)

97. Laboratory Corporation of America(410 KB)

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

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

100. Latvian Medical Genetics Association(107 KB)

101. LNE G-Med NB(63 KB)

102. LRQA NB(66 KB)

103. MetBioNet(20 KB)

104. Molecular Genetics laboratory of the Northern Genetics Service  français (fr)

105. mosaiques-diagnostics  Deutsch (de)

106. Muscular Dystrophy Ireland(20 KB)

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

108. Netherland - Dutch competent authority(148 KB)

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

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

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

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

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

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

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

116. NHS European office(174 KB)

117. NHS National services Scotland(2 MB)

118. NHSBT Histocompatibility & Immunogenetics Laboratories(345 KB)

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

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

121. Norwegian Directorate of Health(786 KB)

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

123. Paul Ehrlich Institut(69 KB)

124. PHG Foundation(194 KB)

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

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

127. Portuguese Society of Human Genetics(7 KB)

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

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

130. Roche(200 KB)

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

132. Sanquin Diagnostic Services(667 KB)

133. Saudi Food and Drug Authority(61 KB)

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

135. Scottish Microbiology Forum(59 KB)

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

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

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

139. Société Française de Génétique Humaine(8 KB)

140. Spanish Competent Authorities – Aemps  español (es)

141. Spanish Society of Human Genetics(13 KB)

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

143. Standing Committee of European Doctors(112 KB)

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

145. Sweden - Medical Product Agency(172 KB)

146. Swedish Society of Medical Genetics(205 KB)

147. Swedish Society of Medicine(191 KB)

148. Swiss Agency for Therapeutic Products(56 KB)

149. Team-NB association(69 KB)

150. TÜV Rheinland LGA Products GmbH(2 MB)

151. TÜV SUD AG(356 KB)

152. TÜV SÜD Product Service GmbH(356 KB)

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

154. UK Genetic testing Network(39 KB)

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

156. UK Newborn Screening Laboratories Network(16 KB)

157. UK Royal College of Pathologists(205 KB)

158. UL International UK Ltd(150 KB)

159. VAD parrallel Distributor(183 KB)

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

161. Which(128 KB)