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Asian Institute of Research, Journal Publication, Journal Academics, Education Journal, Asian Institute
Asian Institute of Research, Journal Publication, Journal Academics, Education Journal, Asian Institute

Economics and Business

Quarterly Reviews

ISSN 2775-9237 (Online)

asian institute research, jeb, journal of economics and business, economics journal, accunting journal, business journal, managemet journal
asian institute research, jeb, journal of economics and business, economics journal, accunting journal, business journal, managemet journal
asian institute research, jeb, journal of economics and business, economics journal, accunting journal, business journal, managemet journal
asian institute research, jeb, journal of economics and business, economics journal, accunting journal, business journal, managemet journal
open access

Published: 25 November 2023

Regulation of Medical Devices – A Poland and U.S. Study: Marketing and Legal Aspects

Richard J. Hunter, Jr., Héctor R. Lozada, John H. Shannon, Gary H. Kritz

Seton Hall University, University of Tulsa

asian institute research, jeb, journal of economics and business, economics journal, accunting journal, business journal, management journal

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Pages: 177-199

Keywords: Medical Devices, Foreign Direct Investment, Field Service Corrective Actions, Advertising, Conformity, Food and Drug Administration


Consider this scenario: One of your former students working in the medical devices field for over twenty years has been approached by a medical device manufacturer in Poland who wishes to market its medical devices in the European Union and eventually expand into the United States. You learn that the Polish government is especially interested in pursuing this opportunity as part of its larger outward foreign direct investment strategy. Your student is being considered as the CEO of prospective U.S. operations. Part I is a study of the various issues that will confront the potential Polish exporter in meeting European Union standards which will guarantee compliance with EU Regulation (EU) 2017/745 on medical devices (MDR). Part II discusses U.S. regulations concerning the importation of medical devices into the United States and the advertising & labeling of such devices.


  1. Abely, C. (2019). E-commerce transactions and country of origin marking for imported products: A gap between statutory purpose and legal requirements. Virginia Journal of International Law, 59: 1-45.

  2. (2022). Medical Device Marketing: An HCP Marketer’s Guide,

  3. (2022a). Medical Device Advertising Regulations: What to Know,

  4. (2022b). The Key to Selling Medical Devices? Smarter HCP Advertising,

  5. Alford, P.E. (2020). Rethinking FDA regulation of complex problems. Minnesota Journal of Law, Science and Technology, 21: 477-539.

  6. Ambroziak, A. & Hartwell, C.A, (2017). The impact of investments in special economic zones on regional development: The case of Poland. Regional Studies, 52(1): 1322-1331.

  7. ArborMetrix (2021). The value of registries in post-market surveillance.

  8. (August 10),

  9. Baker McKenzie (2022). Regulatory, pricing and reimbursement overview. (December 15),

  10. BMP Medical (2023). What is the difference between a class I medical device and a class II?,

  11. Brkic, K.Z. (2021). How to classify medical devices according to EU MDR. (April 22, 2021),

  12. CE Marking (2022). Polish medical device law renewed. (April 27, 2022),


  14. Chodorek, M., Tracz, M., Lokaj, J., & Izydorczyk, M. (2022). Medical devices & consumer health products 2022: Poland. Chambers and Partners (Practice Guides) (June 24, 2022),


  16. Christen, N. (2021). EU MDR language requirements-what manufacturers and distributors need to know, (June 17, 2021),

  17. Cieslik, A. (2020). What attracts multinational enterprises from the new EU member states to Poland? Eurasian Business Review, 10: 253-269.

  18. Congressional Research Service (2023). Section 301 of the Trade Act of 1974 (In Focus) (January 3, 2023),

  19. Council of the European Communities (1989). Council Directive of 3 October 1989,

  20. Council of the European Communities (2004). Commission interpretative communication on certain aspects of the provisions on televised advertising in the ‘Television Without Frontiers’ Directive,”

  21. Cromos Pharma (2022). Clinical trials in Poland-Country profile 2022.,

  22. Crump, L. (2019). Trump on trade. Negotiation Journal, 35(1): 141-146.

  23. Czerw, A. & Marek, E.M. (2013). Restrictions on the conduct of advertising of medicinal products in Poland and their violations. Acta Poloniae Pharmaceutica – Drug Research, 70(4): 769-776.

  24. Davies, N. (2022). An investor’s guide to central and eastern Europe. Investment Monitor (November 1, 2022), https://www.investmentmonitor-ai/fdi-data/an-investors-guide-to-central-and-eastern-europe/.

  25. DeviceLab (2021). FDA class I medical device information & overview.

  26. (November 12, 2021), devices/.

  27. Dorozynski, T., Swierkocki, J, & Urbaniak, W. (2016). The FDI inflow to special economic zones in Poland. Contemporary Issues in Finance, 98: 135-159.

  28. European Union (2017). Regulation (EU) 2017/745 of the European Parliament and of the Council.,

  29. (2023a), Commerce/Terms and Policies/ Medical and Healthcare Products,,smoking%20cessation%20products%20containing%20nicotine.

  30. (2023b). About Meta's Personal Health and Appearance advertising policy,

  31. Fandi, K.J. (2021). National security tariffs: A threat to effective trade policy. University of Pennsylvania Journal of Business Law, 23: 340-389.

  32. Federal Register (2021). Postmarket surveillance under section 522 of the federal Food, Drug, and Cosmetic Act: Draft guidance for industry and food and drug administrative staff (A notice by the Food and Drug Administration; October 10, 2022),

  33. Food and Drug Administration (FDA) (2018a). Medical device tracking.


  35. Food and Drug Administration (FDA). (2018b). Who must register, list and pay the fee.

  36. Food and Drug Administration (FDA) (2020). Device Labeling.

  37. Food and Drug Administration (FDA) (2021). 2021 device approvals.


  39. Food and Drug Administration (FDA) (2022). Device adverse event overview.


  41. Food and Drug Administration (FDA) (2023a). Import alerts.

  42. Food and Drug Administration (FDA). (2023b). Postmarketing surveillance programs.

  43. Gatt, C. & Halliday, S. (2017). Do you know the requirements and your responsibilities for medical device vigilance reporting? British Standards Institute (BSI) (May 5, 2017),

  44. Gimbel, J. (2020). EU MDR Post-mark surveillance. R&,

  45. Giuntoli, D. (2020), Determine your medical device’s FDA classification before it’s too late. (September 14, 2020),

  46. Gorynia, M., Nowak, J., & Wolniak, R. (2011). Investing in a transition economy. In the changing nature of doing business in transition economies: (Marinov, M. & Marinova, S., eds.), 148-182. Springer (Palgrave MacMillan): London, U.K.

  47. Government of Poland (2018). Certificates of free sale for medical devices.,

  48. Gronkvist, F. (2022). CE certificate of conformity: A complete guide.

  49. (February 16, 2022),

  50. Gubanski, J., Gac, M., & Malobecki, I. (2023). Foreign direct investment reviews 2023: Poland. (March 20, 2023),

  51. Hayes, A. (2021). Brownfield investments: definition, advantages, vs, greenfield. Investopedia (February 24, 2021),’brownfield.asp.

  52. Hetrick, C. (2021). What’s the difference between a class I and class II medical device?

  53. (April 8, 2021),

  54. Horvath, G. (2019). Emergent regulatory systems and their challenges: The case of combination medical products, 94: 1697-1767.

  55. Houser, K.A. (2020). The innovation winter is coming: How the U.S.-China trade war endangers the world. San Diego Law Review, 57: 549-608.

  56. Hoxey, E. (2017). What are the differences between market surveillance, post-market surveillance and vigilance? (August 18, 2017),


  58. Hunter, R.J. (2019). A comprehensive view of Poland and foreign direct investment: Pathway to development or flashpoint to conflict within the European Union. Global Journal of Economics and Finance, 3(1): 1-17.

  59. Hunter, R.J. & Lozada, H.R. (2022). “Killing the Golden Goose?”: FDI in Poland 2022, Economics and Business Quarterly Reviews, 5(4): 93-110.

  60. Hunter, R.J., Lozada, H.R., & Shannon, J.H. (2023). The debate on reforms of the WTO appellate process: A proxy for a more serious discussion of the future of the WTO. Economics and Business Quarterly Reviews, 6(1): 86-105.

  61. Hunter, R.J. & Ryan, L.V. (2013). Foreign direct investment 2013-2014. Destination Poland? An update and appraisal. Research in Applied Economics, 5(4): 13-21.

  62. Hunter, R.J., Shannon, J.H., & Amoroso, H.J. (2018). Products liability. Seton Hall University: South Orange, N.J.

  63. Jarman, H. (2021). Neither protective nor harmonized: The crossborder regulation of medical devices in the EU. Health Economics. Policy and Law, 16: 51-63.

  64. Johner, C. (2019). Risk-based approach. (February 17, 2019),

  65. Kaczynski, T., Wycichowski-Kuchta, G., & Zielinska, H. (2020). Medicinal product regulation and product liability in Poland: Overview. Domanski Zakrzewski Palinka Sp. K.,

  66. Kaczynski, T., Pachocki, J. & Radzikowska, M. (2021). Commercialisation of heathcare in Poland: Overview. Domanski Zakrzewski Palinkla Sp. k.,

  67. Kaul, S., Stockbridge, N., & Butler, J. (2020). Benefit-risk tradeoffs in assessment of new drugs and devices. Practical Law, 142: 1974-1988.

  68. KG Legal (2023). Guidelines for the evaluation of medical devices in Poland. (blog),

  69. Koperny, M., Maciorowska, K., Lesniak, W., & Bala, M.M. (2017). Clinical guidelines development process in Poland. Przegl Epidemiol, 71(4): 647-659.

  70. Kouroumalis, A. (2019). Benefit/risk assessment of medicinal products. European Medicines Agency,

  71. Kramer, D.B., Xu, S., & Kesselheim, A.S. (2017). Regulation of medical devices in the United States and the European Union. In The ethical challenges of emerging medical technologies: 1-8. Routledge: Milton Park, UK.

  72. Lam, R.H.W. & Chen, W. (2019). Introduction to biomedical devices. In Biomedical devices: 1-30. Springer: New York.

  73. Lamph, S. (2012). Regulation of medical devices outside the European Union. Journal of the Royal Society of Medicine, 105: 12-21.

  74. Liming, L., Haibo, L., & Yafeng, Z. (2020). Is China’s foreign investment policy to blame for US-China “forced technology transfer” and trade conflict: Comment on Trump administration’s Section 301 investigation of China. China Economist, 15(2): 42-63.

  75. Lloyd’s Bank (2023). Foreign Direct Investment in Poland (Poland: Investing in Poland).


  77. Lyttle, C. (2022). Poland enjoys record year for FDI attraction in 2021, cementing its status as the CEE region’s FDI capital. Investment Monitor (January 25, 2022),

  78. Manita, D., Aakash, V., Rana, A.C., & Sharma P.C. (2019). Regulation and clinical investigation of medical devices in the European Union. Applied Clinical Research, Clinical Trials and Regulatory Affairs, 6(3): 163-181.

  79. Martinez, W.C. (2021). Attack of the clones: An examination and critique of FDA’s medical device regulatory scheme. Tennessee Journal of Law and Public Policy, 15: 344-399.

  80. Matczak, M., Kaczynski, T. & Kruczyk-Gonciarz, A. (2021). Distribution and marketing of drugs in Poland: Overview. Domanski Zakrzewski Palinks Sp.k,

  81. MedTech Europe (2020). Impact of changes under the new EU medical devices regulation (EU) 2017/745 to international registrations. (May 26, 2020),

  82. Melvin, T. & Torre, M. (2019). New medical device regulations: The regulator’s view. EFORT Open Reviews, 4: 351-356.

  83. Miareczko, B. & Jedrzejewska, M. (2002). Product conformity assessment in Poland. Central Institute for Labor Protection-National Research Institute (CIOP-PIB),

  84. Ministry of Health Malaysia (2020). Medical device guidance document: Field corrective action (FCA).,

  85. Noah, D. (2021). Creating a certificate of free sale for your exports. Passages-The International Trade Blog,

  86. Office for the Registration of Medical Products, Medical Devices and Biocidal Products

  87. (2023). accessed May 25, 2023).

  88. Office of the United States Trade Representative (2023). U.S. harmonized tariff schedule.


  90. PAIH. (2023). Why Poland? (last accessed May 25, 2023).

  91. Pane, J., Francisca, R.D.C., Verhamme, K.M.C., Orozco, M., Viroux, H., Rebollo, I., & Sturkenboom, M.C.J.M. (2019). EU postmarket surveillance plans for medical devices. Pharmacoepidemiology and Drug Safety, 28(9): 1155-1165.

  92. Patryn, R., Zagaja, A., & Drozd, M. (2021). Safety of medical devices in Poland – Analysis of withdrawn and suspended certificates of compliance. Medical Devices: Evidence and Research, 14: 239-247.

  93. Pitkanen, H., Raunio, L., Santavaara, I., & Stahlberg, T. (2021). European medical device regulations MDR & IVDR. Business Finland,

  94. Pogonowski. I.C. (1987). Poland: A historical atlas. Hippocrine Books, Inc.: NY, NY.

  95. Polish Investment and Trade Agency (PAIH). (2022). Doing business in Poland- Investor’s guide. PAIH: Warsaw, Poland.

  96. Przezdziecka, E. (2021). FDI in Poland (American Chamber of Commerce in Poland) (Presentation) (March 24, 2021). Available:

  97. QualityMedDev (2021). 21CFR 803: Medical device reporting according to FDA regulation.

  98. (March18, 2021),

  99. Rimsys (2022). Class III medical devices in the United States. (July 6, 2022),


  101. Rish, T. (2021). Understanding the premarket approval (PMA) process. (blog) (July 26, 2021), https://greenlight.gura/blog/premarket-approval-pma.

  102. Rodl & Partner (2020). Successfully investing in Poland. Insights (May 2020),

  103. Rutkowski, E. (2021). Medical Devices and Equipment in Poland: Report 2021,

  104. Safar, L., Colquhoun, H., & Hill, C. (2012). Language requirements for EU medical device labels. Multilingual, 23(6): 1-3.

  105. Simunovic, A., Kranjcec, K., Pekas, M., & Tomic, S. (2023). Journal of Pharmaceutical Policy and Practice, 16: Article 3 (online),

  106. Smith, B. (2023). Ultimate guide to postmarket surveillance of medical devices.

  107. (blog) (February 26, 2023),

  108. Spruill v. Boyle-Midway, Inc. (1962). 308 F.2d 79. United States Court of Appeals for the Fourth Circuit.

  109. Swidrak, B. (2022). New Polish act on medical devices-part 2. (April 27, 2022),

  110. Termini, R.B. & Hoxha, J. (2020). This is not 1976 anymore – Moving forward in medical device safety and the 510(k) clearance process under the United States Federal Food, Drug, and Cosmetic Act. Quinnipiac Health Law Journal, 23: 135-164.

  111. UNCTAD (2022). 2022 world investment report. Geneva: Switzerland.

  112. United States Department of State (2019). 2018 Investment Climate Statements: Poland (Executive Summary). United States Department of State. Available:

  113. Urzad Regestracji Produktow Leczniczych, Wyrobow Medycznych i Produktow Biobojczych (2022).,,acje-dla-osob-niepelnosprawynch.

  114. USA Customs Clearance (2020). Importing medical devices into the US: What you need to know. (September 9, 2020),

  115. Vasiljeva, K., van Duren, B.H., Pandit, H. (2020). Changing device regulations in the European Union: Impact on research, innovation and clinical practice. Indian Journal of Orthopedics, 54(2): 123-129.

  116. World Health Organization (2023). Field Safety Corrective Action,

  117. Wyrob Medyczny (2012). Reporting medical incidents. (November14, 2012),

  118. Yeng, P., Yang, B., & Wolthusen, S.D. (2020). Legal requirements toward enhancing the security of medical devices. Journal of Advanced Computer Science and Applications, 11(11): 666-675.

  119. Zbyszewski, M. (2018). What is a customs bond?

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