Advancing Regulatory Oversight of Medical Device Trials to Align with Clinical Drug Standards in the European Union
The regulation of clinical trials for medicinal products and medical devices has undergone numerous changes in recent years in the European Union, challenging manufacturers and national regulatory agencies as well. With the introduction of combined drug–device products, the regulatory landscape has...
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MDPI AG
2025-06-01
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| Series: | Pharmaceuticals |
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| Online Access: | https://www.mdpi.com/1424-8247/18/6/876 |
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| author | Ádám Pannonhalmi Bence Sipos Róbert Imre Kurucz Gábor Katona Lajos Kemény Ildikó Csóka |
| author_facet | Ádám Pannonhalmi Bence Sipos Róbert Imre Kurucz Gábor Katona Lajos Kemény Ildikó Csóka |
| author_sort | Ádám Pannonhalmi |
| collection | DOAJ |
| description | The regulation of clinical trials for medicinal products and medical devices has undergone numerous changes in recent years in the European Union, challenging manufacturers and national regulatory agencies as well. With the introduction of combined drug–device products, the regulatory landscape has been drastically changed to adapt to novel technological advancements and innovations. A comparative analysis has not yet been published highlighting the main differences and common elements of these two medicinal products, which took up almost all of the market in the pharmaceutical sector. Due to stricter regulations in the field of medical devices, the process from application up until post-market surveillance became more difficult, but a correlation between the regulation of drug trials can also be found. The main differences lie in the risk management systems, where, regardless of the background knowledge of a drug, it is always strict and mandatory structured progress, while in the case of medical devices, it is more flexible based on the risk category of the product. Generally, the utilization of e-health opportunities, transparency, and data accessibility have been improved in both fields. Via the adaptation of the mentioned regulation in the EU, the safety of patients and the efficacy of trials have been greatly increased. This manuscript aims to compare the specific regulations of these two types of medicinal products with a brief outlook on the non-EU sector as well. |
| format | Article |
| id | doaj-art-3b5736e16489495da280df7d6e1f638e |
| institution | Kabale University |
| issn | 1424-8247 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceuticals |
| spelling | doaj-art-3b5736e16489495da280df7d6e1f638e2025-08-20T03:29:48ZengMDPI AGPharmaceuticals1424-82472025-06-0118687610.3390/ph18060876Advancing Regulatory Oversight of Medical Device Trials to Align with Clinical Drug Standards in the European UnionÁdám Pannonhalmi0Bence Sipos1Róbert Imre Kurucz2Gábor Katona3Lajos Kemény4Ildikó Csóka5Department of Dermatology and Allergology, University of Szeged, Korányi Alley 6, H-6720 Szeged, HungaryInstitute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Eötvös Street 6, H-6720 Szeged, HungaryCompetence Centre of Pharmaceutical Development and Clinical Trials, Centre of Excellence for Interdisciplinary Research, Development and Innovation, University of Szeged, Dugonics Square 13, H-6720 Szeged, HungaryInstitute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Eötvös Street 6, H-6720 Szeged, HungaryDepartment of Dermatology and Allergology, University of Szeged, Korányi Alley 6, H-6720 Szeged, HungaryInstitute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Eötvös Street 6, H-6720 Szeged, HungaryThe regulation of clinical trials for medicinal products and medical devices has undergone numerous changes in recent years in the European Union, challenging manufacturers and national regulatory agencies as well. With the introduction of combined drug–device products, the regulatory landscape has been drastically changed to adapt to novel technological advancements and innovations. A comparative analysis has not yet been published highlighting the main differences and common elements of these two medicinal products, which took up almost all of the market in the pharmaceutical sector. Due to stricter regulations in the field of medical devices, the process from application up until post-market surveillance became more difficult, but a correlation between the regulation of drug trials can also be found. The main differences lie in the risk management systems, where, regardless of the background knowledge of a drug, it is always strict and mandatory structured progress, while in the case of medical devices, it is more flexible based on the risk category of the product. Generally, the utilization of e-health opportunities, transparency, and data accessibility have been improved in both fields. Via the adaptation of the mentioned regulation in the EU, the safety of patients and the efficacy of trials have been greatly increased. This manuscript aims to compare the specific regulations of these two types of medicinal products with a brief outlook on the non-EU sector as well.https://www.mdpi.com/1424-8247/18/6/876medical devicemedicinal productdrug developmentclinical trialregulatory sciencemedical device regulation |
| spellingShingle | Ádám Pannonhalmi Bence Sipos Róbert Imre Kurucz Gábor Katona Lajos Kemény Ildikó Csóka Advancing Regulatory Oversight of Medical Device Trials to Align with Clinical Drug Standards in the European Union Pharmaceuticals medical device medicinal product drug development clinical trial regulatory science medical device regulation |
| title | Advancing Regulatory Oversight of Medical Device Trials to Align with Clinical Drug Standards in the European Union |
| title_full | Advancing Regulatory Oversight of Medical Device Trials to Align with Clinical Drug Standards in the European Union |
| title_fullStr | Advancing Regulatory Oversight of Medical Device Trials to Align with Clinical Drug Standards in the European Union |
| title_full_unstemmed | Advancing Regulatory Oversight of Medical Device Trials to Align with Clinical Drug Standards in the European Union |
| title_short | Advancing Regulatory Oversight of Medical Device Trials to Align with Clinical Drug Standards in the European Union |
| title_sort | advancing regulatory oversight of medical device trials to align with clinical drug standards in the european union |
| topic | medical device medicinal product drug development clinical trial regulatory science medical device regulation |
| url | https://www.mdpi.com/1424-8247/18/6/876 |
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