Recast of the Medical Devices Directives - individual responses

I. REGULATORS

EU/ EFTA

  1. Belgium - Scientific Institute of Public Healthpdf(3 MB)
  1. Belgium - Federal Agency for Medicines and Health Productspdf(69 KB)
  1. Czech Republic - Ministry of Healthpdf(77 KB)
  1. Denmark - Ministry for Health Preventionpdf(608 KB)
  1. Finland - National Agency for Medicinespdf(44 KB)
  1. Finland - Finnish Ministry of Agriculture and Forestrypdf(12 KB)
  1. Autorités de la République françaisepdf(3 MB)
  1. Germany - Bundesministerium für Gesundheitpdf(96 KB)
  1. Germany -Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG)pdf(2 MB)
  1. Germany - BSG - Behörde für Soziales, Familie, Gesundheit und Verbraucherschutz Hamburgpdf(118 KB)
  1. Germany -Bayerisches Staatministerium für Umwelt, Gesundheit und Verbraucherschutzpdf(41 KB)
  1. Ireland - Irish Medicines Boardpdf(88 KB)
  1. Italy - Ministry of Labour, Health and Social Affairspdf(129 KB)
  1. Latvia - Ministry of Healthpdf(31 KB)
  1. Lithuania - Ministry of Health (Confidential)
  1. Malta Standards Authority - 1pdf(147 KB) - 2pdf(54 KB)
  1. Notified Bodies Operations Group (NBOG)pdf(134 KB)
  1. Norway - Directorate of Healthpdf(84 KB)
  1. Poland - Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Confidential)
  1. Slovenia - National Agency for Medicines and Medical Devicespdf(73 KB)
  1. Spain - Ministerio de Sanidad y Consumopdf(403 KB)
  1. Sweden - Medical Product Agencypdf(78 KB)
  1. The Netherlands - Ministerie van Volksgezondheid, Welzijn en Sportpdf(3 MB)
  1. United Kingdom - MHRApdf(67 KB)

GHTF Members

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

II. INDUSTRY

Federations

  1. 1pdf(329 KB)- 2pdf(277 KB)- 3pdf(65 KB)
  1. APD - Association Perspectives Dentaires
  1. Appamed
  1. 1pdf(22 KB)- 2pdf(141 KB)- 3pdf(110 KB)
  1. Association of German Dental Industry
  1. Association of Imaging Producers & Equipment Suppliers
  1. Association of the European Self-Medication Industry
  1. Bundesverband der Arzneimittel - Hersteller e. V.
  1. BV Med Bundesverband Medizintechnologie
  1. Chambre Régionale de Commerce et d'Industrie du Limousin
  1. COCIR
  1. 1pdf(532 KB)- 2pdf(39 KB)- 3pdf(45 KB)
  1. 1pdf(42 KB)- 2pdf(469 KB)
  1. 1pdf(469 KB)- 2pdf(134 KB)
  1. EFCLIN
  1. Eucomed
  1. Eurom VI Medical Technology
  1. Euromcontact
  1. European Association of Authorised Representatives (EAAR)
  1. Federación Española de Empresas de Tecnologia Sanitaria
  1. FIDE - European Dental Industry
  1. GIRP AISBL
  1. Groupement des industriels et fabricants de l'optique / EUROM 1
  1. International Pharmaceutical Aerosol Consortium on Regulation and Science
  1. 1pdf(47 KB)- 2pdf(124 KB)
  1. Malta Dental Technology Association
  1. Medical Devices Manufacturers Association
  1. Medical Imaging and Technology Alliance
  1. Medical Technology Association of Australia
  1. Medicoindustrien
  1. National Association of Dental Laboratories and Technicians
  1. Nefemed
  1. SISMIP - Enterprise Europe Network
  1. Snitem - The French association of medical technology industry (Confidential)
  1. Sony Deutschland GmbH (Confidential)
  1. 1pdf(311 KB)- 2pdf(93 KB)
  1. Surgical Dressing Manufacturers Association
  1. Swedish Medtech
  1. 1pdf(42 KB)- 2pdf(160 KB)
  1. The Association of Contact Lens Manufacturers
  1. Union Patronale des Prothésistes Dentaires de Normandie
  1. US Combination Products Coalition
  1. ZVEI Division Medical Engineering

Individual companies

  1. Alcon
  1. Alliance Boots (Confidential)
  1. 1pdf(11 KB)- 2pdf(160 KB)
  1. 1 2pdf(7 KB)-
  1. Austromed
  1. Baxter
  1. BD Technologies (Confidential)
  1. Biomet Spain Orthopaedics
  1. Biomet UK Ltd (Confidential)
  1. Biotronik
  1. Boehringer Ingelheim GmbH (Confidential)
  1. Boston Scientific International sa
  1. Cook Ireland Ltd and William Cook Europe ApS
  1. 1pdf(7 KB)- 2pdf(160 KB)
  1. 1pdf(42 KB)- 2pdf(160 KB)
  1. Genzyme
  1. GlaxoSmithKline Services Unlimited (Confidential)
  1. Gutmann MD GmbH
  1. Johnson and Johnson
  1. 1pdf(5 KB)- 2pdf(160 KB)
  1. Kaltenbach & Voigt GmbH (Confidential)
  1. 1pdf(47 KB)- 2pdf(160 KB)
  1. Laboratoire Bongert (Confidential)
  1. 1pdf(11 KB)- 2pdf(160 KB)
  1. 1pdf(59 KB)- 2pdf(160 KB)
  1. Norgine
  1. Novartis
  1. Operon sa (Confidential)
  1. 1pdf(7 KB)- 2pdf(160 KB)
  1. Pfizer (Confidential)
  1. PhotoMed Technologies Inc
  1. 1pdf(11 KB)- 2pdf(160 KB)
  1. Reckitt Benckiser Healthcare
  1. 1pdf(27 KB)- 2pdf(160 KB)
  1. Roche Diagnostic GmbH
  1. Sanofi-Aventis
  1. SIGH Ltd
  1. Smith and Nephew (Confidential)
  1. Smith and Nephew Endoscopy (Confidential)
  1. St Jude Medical
  1. Stryker EMEA
  1. 1pdf(92 KB)- 2pdf(160 KB)
  1. 1pdf(53 KB)- 2pdf(160 KB)
  1. Toiletry Sales Ltd (Confidential)
  1. UP Dental GmbH (Germany) and Ultradent (USA)
  1. Vistacom/Inotag
  1. Warren Solano (Confidential)
  1. 1pdf(24 KB)- 2pdf(160 KB)
  1. Zimmer Inc (Confidential)

III. HEALTHCARE PROFESSIONALS AND ACADEMICS

  1. ABDA - Bundesvereinigung deutscher Apothekerverbände
  1. ADKA e.V.
  1. Austrian Red Cross
  1. Bastien Laumonier - Opticien, optométriste
  1. Bernhard Lobmayr (Confidential)
  1. British Association for Tissue Banking
  1. British Medical Association
  1. Central Tissue Bank - Ghent University Hospital (Confidential)
  1. Conseil National de l'Ordre des Médecins
  1. Deutsche Krankenhausgesellschaft
  1. Dr. Kevin Haylett (Manchester University Hospitals)
  1. ECRIN - European Clinical Research Infrastructure Network
  1. 1pdf(24 KB)- 2pdf(91 KB)
  1. European Academy of Sciences and Arts
  1. European Association of Tissue Bank
  1. European Federation of Nurses Association
  1. European Society of Cardiology
  1. Europharma
  1. International Department of the Austrian Medical Chamber
  1. Lab Molecular and Cellular Technology
  1. Laser Safety in Health Care
  1. Mater Dei Hospital Malta
  1. 1pdf(194 KB)- 2pdf(190 KB)
  1. Nordic Institute of Dental Materials
  1. Ordre National des Chirurgiens-Dentistespdf(49 KB)
  1. PGEU Pharmaceutical Group of the European Union
  1. PHG Foundation
  1. Public Health Genomics European Network
  1. RHC CareNet
  1. Société française des ophtalmologistes
  1. 1pdf(10 KB)- 2pdf(160 KB)
  1. Unfallkrankenhaus Berlin
  1. Unternehmung Wiener Krankenanstaltenverbund

IV. PATIENTS AND CONSUMERS

  1. European Patients' Forum
  1. Eurordis - European Organisation for Rare Diseases
  1. GeneWatch UK
  1. Max Gros - Prothésiste (Confidential)
  1. Nathalie Ygon (Confidential)
  1. Rainer Lusga
  1. Raphael Brausch (Confidential)
  1. Walter Cornils

V. NOTIFIED BODIES

  1. AMTAC Certification Services Ltd
  1. BSI Product Services
  1. Det Norske Veritas Certification AS (Confidential)
  1. 1pdf(102 KB)- 2pdf(667 KB)
  1. KEMA
  1. LGA InterCert GmbH
  1. Lloyd's Register Quality Insurance Ltd (Confidential)
  1. LNE/G-MED
  1. MDC Medical Device Certification GmbH
  1. NB - Med
  1. NSAI
  1. SGS United Kingdom Limited
  1. Team NB
  1. TÜV Rheinland Product Safety GmbH
  1. TÜV SÜD AG
  1. TÜV SÜD Products Service GmbH
  1. UL Medical Notified Body/UL International ltd UK (Confidential)
  1. Vd TÜV e.V

VI. OTHERS

  • Consultants / MD Experts
  1. Alan Kentpdf(44 KB)
  1. Dr Hans Haindlpdf(37 KB)
  1. Dr Peter Ruyspdf(30 KB)
  1. Medidas Medical Technologies (Confidential)
  1. 1pdf(10 KB)- 2pdf(11 KB)
  1. 1pdf(12 KB)- 2pdf(8 KB)
  1. Voisin Consulting

Standardisation Bodies

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

Health Insurance / Social Security

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

Others

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