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8008-4fd7-acf7-9d03448d49e5
42. European Commission. Commission notice The ‘Blue Guide’ on
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43. Council Directive of 20 June 1990 on the approximation of the laws
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https://eur-lex.europa.eu/eli/dir/1990/385/oj/eng
44. Council Directive 93/42/EEC of 14 June 1993 concerning medical
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lex.europa.eu/eli/dir/1993/42/oj/eng
45. Directive 98/79/EC of the European Parliament and of the Council of
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dir/1998/79/oj/eng
46. Directive 2000/70/EC of the European Parliament and of the Council
of 16 November 2000 amending Council Directive 93/42/EEC as
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eur-lex.europa.eu/eli/dir/2005/50/oj/eng
50. Commission Regulation (EU) No 722/2012 of 8 August 2012
concerning particular requirements regarding the requirements laid
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to active implantable medical devices and medical devices manufactured
utilizing tissues of animal origin. Published 8 August 2012. Accessed 24
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51. Commission Regulation (EU) No 207/2012 of 9 March 2012
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reg/2012/207/oj/eng
52. Directive 2007/47/EC of the European Parliament and of the Council
of 5 September 2007 amending Council Directive 90/385/EEC
on the approximation of the laws of the Member States relating to
active implantable medical devices, Council Directive 93/42/EEC
concerning medical devices and Directive 98/8/EC concerning the
placing of biocidal products on the market. Published 5 September
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EN/TXT/PDF/?uri=CELEX:32007L0047&from=en
53. 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. Published 23 April 2020. Accessed 24 March 2025. https://
eur-lex.europa.eu/eli/reg/2020/561/oj/eng
54. Regulation (EU) 2022/112 of the European Parliament and of the
Council of 25 January 2022 amending Regulation (EU) 2017/746 as
regards transitional provisions for certain in vitro diagnostic medical
devices and the deferred application of conditions for in-house devices.
Published 25 January 2022. Accessed 24 March 2025. https://eur-lex.
europa.eu/eli/reg/2022/112/oj/eng
55. Regulation (EU) 2023/607 of the European Parliament and of the
Council of 15 March 2023 amending Regulations (EU) 2017/745
and (EU) 2017/746 as regards the transitional provisions for certain
medical devices and in vitro diagnostic medical devices. Published 15
March 2023. Accessed 24 March 2025. https://eur-lex.europa.eu/eli/
reg/2023/607/oj/eng
56. European Commission. Proposal for a Regulation of the European
Parliament and of the Council amending Regulations (EU) 2017/745
and (EU) 2017/746 as regards the transitional provisions for certain
medical devices and in vitro diagnostic medical devices. Accessed
26 June 2024. https://health.ec.europa.eu/system/files/2023-01/
mdr_proposal.pdf
57. European Medicines Agency. Committee for Medicinal Products for
Human Use (CHMP). Role of the CHMP. Accessed March 2025.
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products-human-use-chmp
58. European Commission. EUDAMED database. Accessed 26 June
2024. https://ec.europa.eu/tools/eudamed/#/screen/home
59. Medical Device Coordination Group. MDCG 2019-9 Rev.1.
Summary of safety and clinical performance. A guide for
manufacturers and notified bodies. Published March 2022. Accessed
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8d51-495c-9ab9-985a9f39ece4_en?filename=md_mdcg_2019_9_
sscp_en.pdf
60. Regulation (EU) 2021/2282 of the European Parliament and of the
Council of 15 December 2021 on health technology assessment and
amending Directive 2011/24/EU. Accessed 24 March 2025. https://
eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2282
61. European Commission. Regulation on Health Technology
Assessment. Accessed 24 March 2025. https://health.ec.europa.eu/
health-technology-assessment_en
62. World Health Organization. Substandard and falsified medical
products. 3 December 2024. Accessed 24 March 2025. https://www.
who.int/news-room/fact-sheets/detail/substandard-and-falsified-
medical-products
63. de Bruijn ACP, et al. Counterfeit Medical Devices, a Risk Indication.
RIVM Letter Report 360060001/2009 Dutch National Institute for
Public Health and the Environment. Accessed 24 March 2025. https://
www.rivm.nl/bibliotheek/rapporten/360060001.pdf
64. Counterfeit Medicines and Similar Crimes. Updated 15 December
2025. Accessed 24 March 2025. https://rm.coe.int/168071e094
65. Council of Europe. Medicrime Convention. Accessed 24 March 2025.
https://www.coe.int/en/web/medicrime/the-convention
Fundamentals of Medical Device Regulations: A Global Perspective
approach (2000). Published 16 May 2000. Accessed 24 March 2025.
https://op.europa.eu/en/publication-detail/-/publication/4f6721ee-
8008-4fd7-acf7-9d03448d49e5
42. European Commission. Commission notice The ‘Blue Guide’ on
the implementation of EU product rules 2022 (Text with EEA
relevance) 2022/C 247/01. Published 29 June 2022. Accessed
24 March 2025. https://eur-lex.europa.eu/legal-content/EN/
TXT/?uri=uriserv:OJ.C_.2022.247.01.0001.01.ENG
43. Council Directive of 20 June 1990 on the approximation of the laws
of the Member States relating to active implantable medical devices
(90/385/EEC). Published 20 June 1990. Accessed 24 March 2025.
https://eur-lex.europa.eu/eli/dir/1990/385/oj/eng
44. Council Directive 93/42/EEC of 14 June 1993 concerning medical
devices. Published 14 June 1993. Accessed 24 March 2025. https://eur-
lex.europa.eu/eli/dir/1993/42/oj/eng
45. Directive 98/79/EC of the European Parliament and of the Council of
27 October 1998 on in vitro diagnostic medical devices. Published 27
October 1998. Accessed 24 March 2025. https://eur-lex.europa.eu/eli/
dir/1998/79/oj/eng
46. Directive 2000/70/EC of the European Parliament and of the Council
of 16 November 2000 amending Council Directive 93/42/EEC as
regards medical devices incorporating stable derivates of human blood
or human plasma. Published 16 November 2000. Accessed 24 March
2025. https://eur-lex.europa.eu/eli/dir/2000/70/oj/eng
47. Directive 2001/104/EC of the European Parliament and of the
Council of 7 December 2001 amending Council Directive 93/42/EEC
concerning medical devices. Published 7 December 2001. Accessed 24
March 2025. https://eur-lex.europa.eu/eli/dir/2001/104/oj/eng
48. Commission Directive 2003/12/EC of 3 February 2003 on the
reclassification of breast implants in the framework of Directive
93/42/EEC concerning medical devices. Published 3 February 2003.
Accessed 24 March 2025. https://eur-lex.europa.eu/legal-content/EN/
TXT/?uri=CELEX:32003L0012
49. 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. Published 11 August 2005. Accessed 24 March 2025. https://
eur-lex.europa.eu/eli/dir/2005/50/oj/eng
50. Commission Regulation (EU) No 722/2012 of 8 August 2012
concerning particular requirements regarding 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
utilizing tissues of animal origin. Published 8 August 2012. Accessed 24
March 2025. http://eur-lex.europa.eu/eli/reg/2012/722/oj/eng
51. Commission Regulation (EU) No 207/2012 of 9 March 2012
on electronic instructions for use of medical devices. Published 9
March 2012. Accessed 24 March 2025. https://eur-lex.europa.eu/eli/
reg/2012/207/oj/eng
52. Directive 2007/47/EC of the European Parliament and of the Council
of 5 September 2007 amending Council Directive 90/385/EEC
on the approximation of the laws of the Member States relating to
active implantable medical devices, Council Directive 93/42/EEC
concerning medical devices and Directive 98/8/EC concerning the
placing of biocidal products on the market. Published 5 September
2007. Accessed 26 June 2024. https://eur-lex.europa.eu/legal-content/
EN/TXT/PDF/?uri=CELEX:32007L0047&from=en
53. 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. Published 23 April 2020. Accessed 24 March 2025. https://
eur-lex.europa.eu/eli/reg/2020/561/oj/eng
54. Regulation (EU) 2022/112 of the European Parliament and of the
Council of 25 January 2022 amending Regulation (EU) 2017/746 as
regards transitional provisions for certain in vitro diagnostic medical
devices and the deferred application of conditions for in-house devices.
Published 25 January 2022. Accessed 24 March 2025. https://eur-lex.
europa.eu/eli/reg/2022/112/oj/eng
55. Regulation (EU) 2023/607 of the European Parliament and of the
Council of 15 March 2023 amending Regulations (EU) 2017/745
and (EU) 2017/746 as regards the transitional provisions for certain
medical devices and in vitro diagnostic medical devices. Published 15
March 2023. Accessed 24 March 2025. https://eur-lex.europa.eu/eli/
reg/2023/607/oj/eng
56. European Commission. Proposal for a Regulation of the European
Parliament and of the Council amending Regulations (EU) 2017/745
and (EU) 2017/746 as regards the transitional provisions for certain
medical devices and in vitro diagnostic medical devices. Accessed
26 June 2024. https://health.ec.europa.eu/system/files/2023-01/
mdr_proposal.pdf
57. European Medicines Agency. Committee for Medicinal Products for
Human Use (CHMP). Role of the CHMP. Accessed March 2025.
https://www.ema.europa.eu/en/committees/committee-medicinal-
products-human-use-chmp
58. European Commission. EUDAMED database. Accessed 26 June
2024. https://ec.europa.eu/tools/eudamed/#/screen/home
59. Medical Device Coordination Group. MDCG 2019-9 Rev.1.
Summary of safety and clinical performance. A guide for
manufacturers and notified bodies. Published March 2022. Accessed
June 2024. https://health.ec.europa.eu/document/download/5f082b2f-
8d51-495c-9ab9-985a9f39ece4_en?filename=md_mdcg_2019_9_
sscp_en.pdf
60. Regulation (EU) 2021/2282 of the European Parliament and of the
Council of 15 December 2021 on health technology assessment and
amending Directive 2011/24/EU. Accessed 24 March 2025. https://
eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2282
61. European Commission. Regulation on Health Technology
Assessment. Accessed 24 March 2025. https://health.ec.europa.eu/
health-technology-assessment_en
62. World Health Organization. Substandard and falsified medical
products. 3 December 2024. Accessed 24 March 2025. https://www.
who.int/news-room/fact-sheets/detail/substandard-and-falsified-
medical-products
63. de Bruijn ACP, et al. Counterfeit Medical Devices, a Risk Indication.
RIVM Letter Report 360060001/2009 Dutch National Institute for
Public Health and the Environment. Accessed 24 March 2025. https://
www.rivm.nl/bibliotheek/rapporten/360060001.pdf
64. Counterfeit Medicines and Similar Crimes. Updated 15 December
2025. Accessed 24 March 2025. https://rm.coe.int/168071e094
65. Council of Europe. Medicrime Convention. Accessed 24 March 2025.
https://www.coe.int/en/web/medicrime/the-convention