Role of Microsponge Drug Delivery Systems In Improving Therapeutic Outcomes In Rheumatoid Arthritis
EU MDR
DOI:
https://doi.org/10.22270/ajprd.v14i01.1701Abstract
Rheumatoid arthritis (RA) is a chronic systemic autoimmune inflammatory disorder primarily affecting synovial joints and leading to progressive joint destruction, disability, and reduced quality of life. In addition to joint involvement, RA is associated with multiple extra-articular manifestations involving the cardiovascular, pulmonary, ocular, and nervous systems. The etiology of RA is multifactorial, involving genetic predisposition, environmental factors such as smoking, and immune dysregulation. This review article provides a comprehensive overview of rheumatoid arthritis, including its historical background, etiology, pathophysiology, clinical manifestations, diagnostic criteria, and current therapeutic strategies. Special emphasis is given to the role of cytokines, immune cells, autoantibodies, and inflammatory mediators in disease progression. The review also discusses conventional and biological disease-modifying antirheumatic drugs (DMARDs), their mechanisms of action, and associated adverse effects. Understanding the complex pathogenesis and evolving treatment options of RA is essential for improving disease management, minimizing complications, and enhancing patient outcomes.
Downloads
References
Eamonn Hoxey, Comparison of the annexes of the European Medical Devices Directive (93/42/EEC) and the Medical Devices Regulation ((EU) 2017/745), accessed on 11/10/2005, Accessed at https://www.medical-device-regulation.eu/wpcontent/uploads/2020/09/MDD_MDR_annexes_Comparison.pdf
Alan G. Fraser, Rita F. Redberg, Tom Melvin The Origins of Regulations for Pharmaceutical Products and Medical Devices – What Can be Learned for the Governance of Medical Devices in Europe, accessed on 26/05/2025, accessed at https://www.cambridge.org/core/journals/european-review/article/origins-of-regulations-for-pharmaceutical-products-and-medical-devices-what-can-be-learned-for-the-governance-of-medical-devices-in-europe/04FF53F203DB0B911B1821B6749A7D7D
European Commission. MEDDEV 2.7/1 revision 4. Clinical evaluation: a guide for manufacturers and notified bodies under directives 93/42/EEC and 90/385/EEC. Published June 2016. Accessed April 5,2019 accessed at Directive - 65/65 - EN - EUR-Lex
European Commission. Medical Device Directive (MDD). Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Accessed April 5, 2019. Accessed at https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices
Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards OJ C 136, accessed on 4.6.1985, pp. (1–9) accessed at EUR-Lex - 31985Y0604(01) - EN - EUR-Lex
Stiina aarum, Claudia pop Multistakeholder scientific advice for medicinal products used in combination with a medical device or a companion diagnostic in the EU—summary of a Focus group discussion accessed on 2025 Jul 10 accessed at Multistakeholder scientific advice for medicinal products used in combination with a medical device or a companion diagnostic in the EU—summary of a Focus group discussion - PMC
Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (Text with EEA relevance) PE/76/2021/REV/1OJ L 20, accessed on 31.1.2022, pp. (1–37) accessed at Regulation - 2022/123 - EN - EUR-Lex
Medical devices expert group medical devices and their impact on public health final report accessed on 05-06-2002 corr 1. accessed at Report the functioning the Medical Devices Directive
Sujatha katru, New Era in Medical Device Regulations in the European Union 2021 accessed on new-era-in-medical-device-regulations-in-the-european-union-libre.pdf
French-Mowat E, Burnett J. How are medical devices regulated in the European Union? Journal of the Royal Society of Medicine. Accessed on april 2012;105(1_suppl):(22-28). Accessed at doi:10.1258/jrsm.2012.120036
Elaine French-Mowat and Joanne Burnett how are medical devices regulated in the European union accessed on April 2012 accessed at How are medical devices regulated in the European Union?
Fröschl ,B., Bornschein ,B., Brunner-Ziegler ,S., Conrads-Frank ,A., Eisenmann ,A., Gartlehner ,G., et al.: Methodenhandbuch für Health Technology Assessment Version 1. Austria; 2012 accessed on Critical Review of European Health-Economic Guidelines for the Health Technology Assessment of Medical Devices
Kramer DB, Xu S, Kesselheim AS (2012) How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review. PLoS Med 9(7): e1001276. Accessed on How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review | PLOS Medicine
Campbell B, Campbell M, Dobson L, et al. Assessing the value of innovative medical devices and diagnostics: the importance of clear and relevant claims of benefit. Int J Technol Assess Health Care. 2018; 34(4):419-424. ASSESSING THE VALUE OF INNOVATIVE MEDICAL DEVICES AND DIAGNOSTICS: THE IMPORTANCE OF CLEAR AND RELEVANT CLAIMS OF BENEFIT - PubMed
European Commission. Medical Device Regulation (MDR). 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. Accessed on April 5, 2019. 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
Miglierini G. Pharma World Magazine. Towards the harmonisation of clinical evaluation of medical devices. Published April 19, 2018. Accessed on April 5, 2019. Accessed at Towards the harmonisation of evaluation of medical devices
Shah SG, Robinson I. Benefits of and barriers to involving users in medical device technology development and evaluation. Int J Technol Assess Health Care. Accessed on April 20, 2023 Pg no:131-137. Accessed at Benefits of and barriers to involving users in medical device technology development and evaluation - PubMed
Money AG, Barnett J, Kuljis J, Craven MP, Martin JL, Young T. The role of the user within the medical device design and development process: medical device manufacturers' perspectives. BMC Med Inform Decis Mak. Accessed on 2011 Feb 28 accessed at The role of the user within the medical device design and development process: medical device manufacturers' perspectives - PubMed
Herman A, Goossens A. The need to disclose the composition of medical devices at the European level. Contact Dermatitis. Accessed on 2019 Sep;81(3):159-160. Accessed at The need to disclose the composition of medical devices at the European level - PubMed
Jacob Bergsland, Ole Jakob Elle & Erik Fosse (2014) Barriers to medical device innovation, Medical Devices: Evidence and Research, , 205-209, DOI: 10.2147/ MDER.S43369. Accessed at MDER-43369-barriers-to-medical-device-innovation
Downloads
Published
Versions
- 2026-02-17 (2)
- 2026-02-15 (1)
How to Cite
Issue
Section
License
Copyright (c) 2026 Golechha P. Abhinandan, Dr. Sandeep C. Atram, Dr. Vikrant P.Wankhade, Dr. Nishan N.Bobade, Dr Shrikant D Pande
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
AUTHORS WHO PUBLISH WITH THIS JOURNAL AGREE TO THE FOLLOWING TERMS:
Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
. 