Recast of the Medical Devices Directives - individual responses

I. REGULATORS

EU/ EFTA

1. Belgium - Scientific Institute of Public Health(3 MB)

2. Belgium - Federal Agency for Medicines and Health Products(69 KB)

3. Czech Republic - Ministry of Health(77 KB)

4. Denmark - Ministry for Health Prevention(608 KB)

5. Finland - National Agency for Medicines(44 KB)

6. Finland - Finnish Ministry of Agriculture and Forestry(12 KB)

7. Autorités de la République française(3 MB)

8. Germany - Bundesministerium für Gesundheit(96 KB)

9. Germany -Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG)(2 MB)

10. Germany - BSG - Behörde für Soziales, Familie, Gesundheit und Verbraucherschutz Hamburg(118 KB)

11. Germany -Bayerisches Staatministerium für Umwelt, Gesundheit und Verbraucherschutz(41 KB)

12. Ireland - Irish Medicines Board(88 KB)

13. Italy - Ministry of Labour, Health and Social Affairs(129 KB)

14. Latvia - Ministry of Health(31 KB)

15. Lithuania - Ministry of Health (Confidential)

16. Malta Standards Authority - 1(147 KB) - 2(54 KB)

17. Notified Bodies Operations Group (NBOG)(134 KB)

18. Norway - Directorate of Health(84 KB)

19. Poland - Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Confidential)

20. Slovenia - National Agency for Medicines and Medical Devices(73 KB)

21. Spain - Ministerio de Sanidad y Consumo(403 KB)

22. Sweden - Medical Product Agency(78 KB)

23. The Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport(3 MB)

24. United Kingdom - MHRA(67 KB)

GHTF Members

24. Australia - Therapeutic Goods Administration (Confidential)

25. Canada - Health Canada / Santé Canada (Confidential)

26. Japan - Government of Japan (Confidential)

27. United States of America - Food and Drug Administration (Confidential)

II. INDUSTRY

Federations

28. 1(329 KB)- 2(277 KB)- 3(65 KB)

29. APD - Association Perspectives Dentaires

30. Appamed

31. 1(22 KB)- 2(141 KB)- 3(110 KB)

32. Association of German Dental Industry

33. Association of Imaging Producers & Equipment Suppliers

34. Association of the European Self-Medication Industry

35. Bundesverband der Arzneimittel - Hersteller e. V.

36. BV Med Bundesverband Medizintechnologie

37. Chambre Régionale de Commerce et d'Industrie du Limousin

38. COCIR

39. 1(532 KB)- 2(39 KB)- 3(45 KB)

40. 1(42 KB)- 2(469 KB)

41. 1(469 KB)- 2(134 KB)

42. EFCLIN

43. Eucomed

44. Eurom VI Medical Technology

45. Euromcontact

46. European Association of Authorised Representatives (EAAR)

47. Federación Española de Empresas de Tecnologia Sanitaria

48. FIDE - European Dental Industry

49. GIRP AISBL

50. Groupement des industriels et fabricants de l'optique / EUROM 1

51. International Pharmaceutical Aerosol Consortium on Regulation and Science

52. 1(47 KB)- 2(124 KB)

53. Malta Dental Technology Association

54. Medical Devices Manufacturers Association

55. Medical Imaging and Technology Alliance

56. Medical Technology Association of Australia

57. Medicoindustrien

58. National Association of Dental Laboratories and Technicians

59. Nefemed

60. SISMIP - Enterprise Europe Network

61. Snitem - The French association of medical technology industry (Confidential)

62. Sony Deutschland GmbH (Confidential)

63. 1(311 KB)- 2(93 KB)

64. Surgical Dressing Manufacturers Association

65. Swedish Medtech

66. 1(42 KB)- 2(160 KB)

67. The Association of Contact Lens Manufacturers

68. Union Patronale des Prothésistes Dentaires de Normandie

69. US Combination Products Coalition

70. ZVEI Division Medical Engineering

Individual companies

71. Alcon

72. Alliance Boots (Confidential)

73. 1(11 KB)- 2(160 KB)

74. 1 2(7 KB)-

75. Austromed

76. Baxter

77. BD Technologies (Confidential)

78. Biomet Spain Orthopaedics

79. Biomet UK Ltd (Confidential)

80. Biotronik

81. Boehringer Ingelheim GmbH (Confidential)

82. Boston Scientific International sa

83. Cook Ireland Ltd and William Cook Europe ApS

84. 1(7 KB)- 2(160 KB)

85. 1(42 KB)- 2(160 KB)

86. Genzyme

87. GlaxoSmithKline Services Unlimited (Confidential)

88. Gutmann MD GmbH

89. Johnson and Johnson

90. 1(5 KB)- 2(160 KB)

91. Kaltenbach & Voigt GmbH (Confidential)

92. 1(47 KB)- 2(160 KB)

93. Laboratoire Bongert (Confidential)

94. 1(11 KB)- 2(160 KB)

95. 1(59 KB)- 2(160 KB)

96. Norgine

97. Novartis

98. Operon sa (Confidential)

99. 1(7 KB)- 2(160 KB)

100. Pfizer (Confidential)

101. PhotoMed Technologies Inc

102. 1(11 KB)- 2(160 KB)

103. Reckitt Benckiser Healthcare

104. 1(27 KB)- 2(160 KB)

105. Roche Diagnostic GmbH

106. Sanofi-Aventis

107. SIGH Ltd

108. Smith and Nephew (Confidential)

109. Smith and Nephew Endoscopy (Confidential)

110. St Jude Medical

111. Stryker EMEA

112. 1(92 KB)- 2(160 KB)

113. 1(53 KB)- 2(160 KB)

114. Toiletry Sales Ltd (Confidential)

115. UP Dental GmbH (Germany) and Ultradent (USA)

116. Vistacom/Inotag

117. Warren Solano (Confidential)

118. 1(24 KB)- 2(160 KB)

119. Zimmer Inc (Confidential)

III. HEALTHCARE PROFESSIONALS AND ACADEMICS

120. ABDA - Bundesvereinigung deutscher Apothekerverbände

121. ADKA e.V.

122. Austrian Red Cross

123. Bastien Laumonier - Opticien, optométriste

124. Bernhard Lobmayr (Confidential)

125. British Association for Tissue Banking

126. British Medical Association

127. Central Tissue Bank - Ghent University Hospital (Confidential)

128. Conseil National de l'Ordre des Médecins

129. Deutsche Krankenhausgesellschaft

130. Dr. Kevin Haylett (Manchester University Hospitals)

131. ECRIN - European Clinical Research Infrastructure Network

132. 1(24 KB)- 2(91 KB)

133. European Academy of Sciences and Arts

134. European Association of Tissue Bank

135. European Federation of Nurses Association

136. European Society of Cardiology

137. Europharma

138. International Department of the Austrian Medical Chamber

139. Lab Molecular and Cellular Technology

140. Laser Safety in Health Care

141. Mater Dei Hospital Malta

142. 1(194 KB)- 2(190 KB)

143. Nordic Institute of Dental Materials

144. Ordre National des Chirurgiens-Dentistes(49 KB)

145. PGEU Pharmaceutical Group of the European Union

146. PHG Foundation

147. Public Health Genomics European Network

148. RHC CareNet

149. Société française des ophtalmologistes

150. 1(10 KB)- 2(160 KB)

151. Unfallkrankenhaus Berlin

152. Unternehmung Wiener Krankenanstaltenverbund

IV. PATIENTS AND CONSUMERS

153. European Patients' Forum

154. Eurordis - European Organisation for Rare Diseases

155. GeneWatch UK

156. Max Gros - Prothésiste (Confidential)

157. Nathalie Ygon (Confidential)

158. Rainer Lusga

159. Raphael Brausch (Confidential)

160. Walter Cornils

V. NOTIFIED BODIES

161. AMTAC Certification Services Ltd

162. BSI Product Services

163. Det Norske Veritas Certification AS (Confidential)

164. 1(102 KB)- 2(667 KB)

165. KEMA

166. LGA InterCert GmbH

167. Lloyd's Register Quality Insurance Ltd (Confidential)

168. LNE/G-MED

169. MDC Medical Device Certification GmbH

170. NB - Med

171. NSAI

172. SGS United Kingdom Limited

173. Team NB

174. TÜV Rheinland Product Safety GmbH

175. TÜV SÜD AG

176. TÜV SÜD Products Service GmbH

177. UL Medical Notified Body/UL International ltd UK (Confidential)

178. Vd TÜV e.V

VI. OTHERS

• Consultants / MD Experts

179. Alan Kent(44 KB)

180. Dr Hans Haindl(37 KB)

181. Dr Peter Ruys(30 KB)

182. Medidas Medical Technologies (Confidential)

183. 1(10 KB)- 2(11 KB)

184. 1(12 KB)- 2(8 KB)

185. Voisin Consulting

Standardisation Bodies

186. Association for the Advancement of Medical Instrumentation

187. ASTM International

188. CEN European Committee for Standardization

189. DIN German Institute for Standardization

190. GS1 Healthcare

191. SIS Swedish Standards Institute

Health Insurance / Social Security

193. Association internationale de la Mutualité

194. CEA Insurers of Europe (Confidential)

195. NHS Connecting for Health

196. NHS European Office

Others

197. Edition CRG

198. International Council on Animal Protection in Pharmaceutical Programmes (ICAPPP)

199. Norwegian Dental Biomaterials Adverse Reaction Unit

200. Textile Services Association