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Recast of the Medical Devices Directives – individual responses

I. Regulators

EU/EFTA

  1. Belgium – Scientific Institute of Public Healthpdf(3 MB) Choose translations of the previous link 
  2. Belgium – Federal Agency for Medicines and Health Productspdf(71 kB) Choose translations of the previous link 
  3. Czech Republic – Ministry of Healthpdf(78 kB) Choose translations of the previous link 
  4. Denmark – Ministry for Health Preventionpdf(623 kB) Choose translations of the previous link 
  5. Finland – National Agency for Medicinespdf(45 kB) Choose translations of the previous link 
  6. Finland – Finnish Ministry of Agriculture and Forestrypdf(13 kB) Choose translations of the previous link 
  7. Autorités de la République françaisepdf(3 MB) Choose translations of the previous link 
  8. Germany – Bundesministerium für Gesundheitpdf(98 kB) Choose translations of the previous link 
  9. Germany - Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG)pdf(2 MB) Choose translations of the previous link 
  10. Germany – BSG – Behörde für Soziales, Familie, Gesundheit und Verbraucherschutz Hamburgpdf(120 kB) Choose translations of the previous link 
  11. Germany – Bayerisches Staatministerium für Umwelt, Gesundheit und Verbraucherschutzpdf(42 kB) Choose translations of the previous link 
  12. Ireland – Irish Medicines Boardpdf(90 kB) Choose translations of the previous link 
  13. Italy – Ministry of Labour, Health and Social Affairspdf(133 kB) Choose translations of the previous link 
  14. Latvia – Ministry of Healthpdf(31 kB) Choose translations of the previous link 
  15. Lithuania – Ministry of Health (Confidential)
  16. Malta Standards Authority – 1pdf(150 kB) Choose translations of the previous link , 2pdf(56 kB) Choose translations of the previous link 
  17. Notified Bodies Operations Group (NBOG)pdf(137 kB) Choose translations of the previous link 
  18. Norway – Directorate of Healthpdf(86 kB) Choose translations of the previous link 
  19. Poland – Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Confidential)
  20. Slovenia – National Agency for Medicines and Medical Devicespdf(75 kB) Choose translations of the previous link 
  21. Spain – Ministerio de Sanidad y Consumopdf(412 kB) Choose translations of the previous link 
  22. Sweden – Medical Product Agencypdf(80 kB) Choose translations of the previous link 
  23. The Netherlands – Ministerie van Volksgezondheid, Welzijn en Sportpdf(3 MB) Choose translations of the previous link 
  24. United Kingdom – MHRApdf(69 kB) Choose translations of the previous link 

GHTF Members

  1. Australia – Therapeutic Goods Administration (Confidential)
  2. Canada – Health Canada / Santé Canada (Confidential)
  3. Japan – Government of Japan (Confidential)
  4. United States of America – Food and Drug Administration (Confidential)

II. Industry

Federations

  1. 1pdf(337 kB) Choose translations of the previous link , 2pdf(283 kB) Choose translations of the previous link , 3pdf(66 kB) Choose translations of the previous link 
  2. APD – Association Perspectives Dentaires
  3. Appamed
  4. 1pdf(23 kB) Choose translations of the previous link , 2pdf(145 kB) Choose translations of the previous link , 3pdf(112 kB) Choose translations of the previous link 
  5. Association of German Dental Industry
  6. Association of Imaging Producers & Equipment Suppliers
  7. Association of the European Self-Medication Industry
  8. Bundesverband der Arzneimittel – Hersteller e. V.
  9. BV Med Bundesverband Medizintechnologie
  10. Chambre Régionale de Commerce et d’Industrie du Limousin
  11. COCIR
  12. 1pdf(544 kB) Choose translations of the previous link , 2pdf(40 kB) Choose translations of the previous link , 3pdf(46 kB) Choose translations of the previous link 
  13. 1pdf(43 kB) Choose translations of the previous link , 2pdf(480 kB) Choose translations of the previous link 
  14. 1pdf(480 kB) Choose translations of the previous link , 2pdf(137 kB) Choose translations of the previous link 
  15. EFCLIN
  16. Eucomed
  17. Eurom VI Medical Technology
  18. Euromcontact
  19. European Association of Authorised Representatives (EAAR)
  20. Federación Española de Empresas de Tecnologia Sanitaria
  21. FIDE – European Dental Industry
  22. GIRP AISBL
  23. Groupement des industriels et fabricants de l’optique / EUROM 1
  24. International Pharmaceutical Aerosol Consortium on Regulation and Science
  25. 1pdf(48 kB) Choose translations of the previous link , 2pdf(127 kB) Choose translations of the previous link 
  26. Malta Dental Technology Association
  27. Medical Devices Manufacturers Association
  28. Medical Imaging and Technology Alliance
  29. Medical Technology Association of Australia
  30. Medicoindustrien
  31. National Association of Dental Laboratories and Technicians
  32. Nefemed
  33. SISMIP – Enterprise Europe Network
  34. Snitem – The French association of medical technology industry (Confidential)
  35. Sony Deutschland GmbH (Confidential)
  36. 1pdf(318 kB) Choose translations of the previous link , 2pdf(95 kB) Choose translations of the previous link 
  37. Surgical Dressing Manufacturers Association
  38. Swedish Medtech
  39. 1pdf(43 kB) Choose translations of the previous link , 2pdf(164 kB) Choose translations of the previous link 
  40. The Association of Contact Lens Manufacturers
  41. Union Patronale des Prothésistes Dentaires de Normandie
  42. US Combination Products Coalition
  43. ZVEI Division Medical Engineering

Individual companies

  1. Alcon
  2. Alliance Boots (Confidential)
  3. 1pdf(11 kB) Choose translations of the previous link , 2pdf(164 kB) Choose translations of the previous link 
  4. 1, 2pdf(8 kB) Choose translations of the previous link 
  5. Austromed
  6. Baxter
  7. BD Technologies (Confidential)
  8. Biomet Spain Orthopaedics
  9. Biomet UK Ltd (Confidential)
  10. Biotronik
  11. Boehringer Ingelheim GmbH (Confidential)
  12. Boston Scientific International sa
  13. Cook Ireland Ltd and William Cook Europe ApS
  14. 1pdf(8 kB) Choose translations of the previous link , 2pdf(164 kB) Choose translations of the previous link 
  15. 1pdf(43 kB) Choose translations of the previous link , 2pdf(164 kB) Choose translations of the previous link 
  16. Genzyme
  17. GlaxoSmithKline Services Unlimited (Confidential)
  18. Gutmann MD GmbH
  19. Johnson and Johnson
  20. 1pdf(5 kB) Choose translations of the previous link , 2pdf(164 kB) Choose translations of the previous link 
  21. Kaltenbach & Voigt GmbH (Confidential)
  22. 1pdf(48 kB) Choose translations of the previous link , 2pdf(164 kB) Choose translations of the previous link 
  23. Laboratoire Bongert (Confidential)
  24. 1pdf(11 kB) Choose translations of the previous link , 2pdf(164 kB) Choose translations of the previous link 
  25. 1pdf(60 kB) Choose translations of the previous link , 2pdf(164 kB) Choose translations of the previous link 
  26. Norgine
  27. Novartis
  28. Operon sa (Confidential)
  29. 1pdf(8 kB) Choose translations of the previous link , 2pdf(164 kB) Choose translations of the previous link 
  30. Pfizer (Confidential)
  31. PhotoMed Technologies Inc
  32. 1pdf(11 kB) Choose translations of the previous link , 2pdf(164 kB) Choose translations of the previous link 
  33. Reckitt Benckiser Healthcare
  34. 1pdf(27 kB) Choose translations of the previous link , 2pdf(164 kB) Choose translations of the previous link 
  35. Roche Diagnostic GmbH
  36. Sanofi-Aventis
  37. SIGH Ltd
  38. Smith and Nephew (Confidential)
  39. Smith and Nephew Endoscopy (Confidential)
  40. St Jude Medical
  41. Stryker EMEA
  42. 1pdf(95 kB) Choose translations of the previous link , 2pdf(164 kB) Choose translations of the previous link 
  43. 1pdf(54 kB) Choose translations of the previous link , 2pdf(164 kB) Choose translations of the previous link 
  44. Toiletry Sales Ltd (Confidential)
  45. UP Dental GmbH (Germany) and Ultradent (USA)
  46. Vistacom/Inotag
  47. Warren Solano (Confidential)
  48. 1pdf(24 kB) Choose translations of the previous link , 2pdf(164 kB) Choose translations of the previous link 
  49. Zimmer Inc (Confidential)

III. Healthcare Professionals and Academics

  1. ABDA – Bundesvereinigung deutscher Apothekerverbände
  2. ADKA e.V.
  3. Austrian Red Cross
  4. Bastien Laumonier – Opticien, optométriste
  5. Bernhard Lobmayr (Confidential)
  6. British Association for Tissue Banking
  7. British Medical Association
  8. Central Tissue Bank – Ghent University Hospital (Confidential)
  9. Conseil National de l’Ordre des Médecins
  10. Deutsche Krankenhausgesellschaft
  11. Dr. Kevin Haylett (Manchester University Hospitals)
  12. ECRIN – European Clinical Research Infrastructure Network
  13. 1pdf(25 kB) Choose translations of the previous link , 2pdf(93 kB) Choose translations of the previous link 
  14. European Academy of Sciences and Arts
  15. European Association of Tissue Bank
  16. European Federation of Nurses Association
  17. European Society of Cardiology
  18. Europharma
  19. International Department of the Austrian Medical Chamber
  20. Lab Molecular and Cellular Technology
  21. Laser Safety in Health Care
  22. Mater Dei Hospital Malta
  23. 1pdf(199 kB) Choose translations of the previous link , 2pdf(195 kB) Choose translations of the previous link 
  24. Nordic Institute of Dental Materials
  25. Ordre National des Chirurgiens-Dentistespdf(50 kB) Choose translations of the previous link 
  26. PGEU Pharmaceutical Group of the European Union
  27. PHG Foundation
  28. Public Health Genomics European Network
  29. RHC CareNet
  30. Société française des ophtalmologistes
  31. 1pdf(10 kB) Choose translations of the previous link - 2pdf(164 kB) Choose translations of the previous link 
  32. Unfallkrankenhaus Berlin
  33. Unternehmung Wiener Krankenanstaltenverbund

IV. Patients and Consumers

  1. European Patients’ Forum
  2. Eurordis – European Organisation for Rare Diseases
  3. GeneWatch UK
  4. Max Gros – Prothésiste (Confidential)
  5. Nathalie Ygon (Confidential)
  6. Rainer Lusga
  7. Raphael Brausch (Confidential)
  8. Walter Cornils

V. Notified Bodies

  1. AMTAC Certification Services Ltd
  2. BSI Product Services
  3. Det Norske Veritas Certification AS (Confidential)
  4. 1pdf(104 kB) Choose translations of the previous link , 2pdf(683 kB) Choose translations of the previous link 
  5. KEMA
  6. LGA InterCert GmbH
  7. Lloyd’s Register Quality Insurance Ltd (Confidential)
  8. LNE/G-MED
  9. MDC Medical Device Certification GmbH
  10. NB – Med
  11. NSAI
  12. SGS United Kingdom Limited
  13. Team NB
  14. TÜV Rheinland Product Safety GmbH
  15. TÜV SÜD AG
  16. TÜV SÜD Products Service GmbH
  17. UL Medical Notified Body/UL International ltd UK (Confidential)
  18. Vd TÜV e.V

VI. Others

Consultants/MD Experts

  1. Alan Kentpdf(45 kB) Choose translations of the previous link 
  2. Dr Hans Haindlpdf(38 kB) Choose translations of the previous link 
  3. Dr Peter Ruyspdf(31 kB) Choose translations of the previous link 
  4. Medidas Medical Technologies (Confidential)
  5. 1pdf(10 kB) Choose translations of the previous link , 2pdf(11 kB) Choose translations of the previous link 
  6. 1pdf(12 kB) Choose translations of the previous link - 2pdf(8 kB) Choose translations of the previous link 
  7. Voisin Consulting

Standardisation Bodies

  1. Association for the Advancement of Medical Instrumentation
  2. ASTM International
  3. CEN European Committee for Standardization
  4. DIN German Institute for Standardization
  5. GS1 Healthcare
  6. SIS Swedish Standards Institute

Health Insurance / Social Security

  1. Association internationale de la Mutualité
  2. CEA Insurers of Europe (Confidential)
  3. NHS Connecting for Health
  4. NHS European Office

Others

  1. Edition CRG
  2. International Council on Animal Protection in Pharmaceutical Programmes (ICAPPP)
  3. Norwegian Dental Biomaterials Adverse Reaction Unit
  4. Textile Services Association