Therapy Classification Binding Text and Guidance

BINDING EU TEXTS

Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products (Text with EEA relevance), OJ L 242, 15.9.2009, p. 3–12, CELEX number: 32009L0120 

Commission Regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises (Text with EEA relevance), OJ L 194, 25.7.2009, p. 7–10, CELEX number: 32009R0668 

Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance), OJ L 324, 10.12.2007, p. 121–137, CELEX number: 32007R1394 

Legal Classification

Legal classification covers:

  • Human body elements
  • medicines/ATMPs (gene therapy, cell therapy, tissue engineering)
  • medical devices 

This section is in development.

 

ATMPs

Various Legal Frameworks   

ATMPs   

Exempted ATMP pathways   

Named patients and compassionate use pathways   

Medicines prepared by pharmacists   

 

CAT scientific recommendations on classification  

ATMPs and Orphan Drugs   

 

ATMPs and Paediatric Drugs   

 

ATMPs and Genetically Modified Organisms   

BINDING TEXTS 

  • Regulation (EU) 2020/1043 of the European Parliament and of the Council of 15 July 2020 on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19), OJ L 231, 17.7.2020, p. 12–16, CELEX number: 32020R1043 
  • Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (Text with EEA relevance), OJ L 125, 21.5.2009, p. 75–97, CELEX number: 32009L0041 
  • Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms (Text with EEA relevance), OJ L 287, 5.11.2003, p. 1–10, CELEX number: 32003R1946 
  • Commission Directive (EU) 2018/350 of 8 March 2018 amending Directive 2001/18/EC of the European Parliament and of the Council as regards the environmental risk assessment of genetically modified organisms, OJ L 67, 9.3.2018, p. 30–45, CELEX number: 32018L0350 
  • Directive 2008/27/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, as regards the implementing powers conferred on the Commission, OJ L 81, 20.3.2008, p. 45–47, CELEX number: 32008L0027 
  • Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC - Commission Declaration, OJ L 106, 17.4.2001, p. 1–39, CELEX number: 32001L0018 

GUIDELINES 

 

ATMPs and Medical Devices   

BINDING TEXTS 

  • Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions (Text with EEA relevance), OJ L 130, 24.4.2020, p. 18–22. 
  • Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance), OJ L 117, 5.5.2017, p. 1–175, CELEX number: 32017R0745 
  • Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance), OJ L 117, 5.5.2017, p. 176–332, CELEX number: 32017R0746 
  • Commission Implementing Decision (EU) 2021/611 of 14 April 2021 amending Implementing Decision (EU) 2020/438 as regards harmonised standards on biological evaluation of medical devices, packaging for terminally sterilised medical devices, sterilisation of health care products and clinical investigation of medical devices for human subjects, C/2021/2434, OJ L 129, 15.4.2021, p. 158–160 
  • Commission Implementing Decision (EU) 2021/610 of 14 April 2021 amending Implementing Decision (EU) 2020/437 as regards harmonised standards on medical vehicles and their equipment, anaesthetic and respiratory equipment, biological evaluation of medical devices, packaging for terminally sterilised medical devices, sterilisation of health care products, clinical investigation of medical devices for human subjects, non-active surgical implants, medical devices utilising animal tissues and their derivatives, electroacoustics and medical electrical equipment, C/2021/2439, OJ L 129, 15.4.2021, p. 153–157 
  • Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance), OJ L 210, 12.8.2005, p. 41–43 
  • Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council (Text with EEA relevance. ), C/2017/7779, OJ L 309, 24.11.2017, p. 7–17 
  • Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (Text with EEA relevance), OJ L 212, 9.8.2012, p. 3–12, CELEX number: 32012R0722 
  • Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices Text with EEA relevance, OJ L 253, 25.9.2013, p. 8–19 
  • Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices (Text with EEA relevance.), C/2019/4068, OJ L 149, 7.6.2019, p. 73–75  
  • Commission Implementing Decision (EU) 2020/437 of 24 March 2020 on the harmonised standards for medical devices drafted in support of Council Directive 93/42/EEC, C/2020/1901, OJ L 90I , 25.3.2020, p. 1–24 
  • Commission Implementing Decision (EU) 2020/438 of 24 March 2020 on the harmonised standards for active implantable medical devices drafted in support of Council Directive 90/385/EEC, C/2020/1902, OJ L 90I , 25.3.2020, p. 25–32 
  • Commission Implementing Decision (EU) 2020/439 of 24 March 2020 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Directive 98/79/EC of the European Parliament and of the Council, C/2020/1903, OJ L 90I , 25.3.2020, p. 33–39:   
  • Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices, C/2021/8984, OJ L 448, 15.12.2021, p. 32–38  
  • Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed), C/2021/8447, OJ L 426, 29.11.2021, p. 9–15
  • Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, OJ L 331, 7.12.1998, p. 1–37, CELEX number: 31998L0079 

GUIDELINES 

 

Not ATMPs: Human body elements for therapeutic applications

Human Blood: BINDING TEXTS 

  • Commission Directive (EU) 2016/1214 of 25 July 2016 amending Directive 2005/62/EC as regards quality system standards and specifications for blood establishments (Text with EEA relevance) C/2016/4641, OJ L 199, 26.7.2016, p. 14–15 
  • Commission Directive 2014/110/EU of 17 December 2014 amending Directive 2004/33/EC as regards temporary deferral criteria for donors of allogeneic blood donations (Text with EEA relevance), OJ L 366, 20.12.2014, p. 81–82 
  • Commission Implementing Directive 2011/38/EU of 11 April 2011 amending Annex V to Directive 2004/33/EC with regards to maximum pH values for platelets concentrates at the end of the shelf life Text with EEA relevance, OJ L 97, 12.4.2011, p. 28–29. 
  • Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments (Text with EEA relevance), OJ L 256, 1.10.2005, p. 41–48, CELEX number: 32005L0062 
  • Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events (Text with EEA relevance), OJ L 256, 1.10.2005, p. 32–40, CELEX number: 32005L0061 
  • Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components (Text with EEA relevance), OJ L 91, 30.3.2004, p. 25–39, CELEX number: 32004L0033 
  • Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC; OJ L 33, 8.2.2003, p. 30–40, CELEX number: 32002L0098 

Human Tissues and cells: BINDING TEXTS 

  • Commission Directive (EU) 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells (Text with EEA relevance), OJ L 93, 9.4.2015, p. 56–68, CELEX number: 32015L0566 
  • Commission Directive (EU) 2015/565 of 8 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells (Text with EEA relevance), OJ L 93, 9.4.2015, p. 43–55, CELEX number: 32015L0565 
  • Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (Text with EEA relevance), OJ L 294, 25.10.2006, p. 32–50, CELEX number: 32006L0086 
  • Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells (Text with EEA relevance), OJ L 38, 9.2.2006, p. 40–52, CELEX number: 32006L0017 
  • Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, OJ L 102, 7.4.2004, p. 48–58, CELEX number: 32004L0023 

Not ATMPs: medical devices containing tissues and cells

This section is in development.

 

Not ATMPs: other 

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