Reflection of the Medical Device Regulation
The MDR states the objectives of the law in the preface. There you will find, among other things, a consideration of small and medium-sized enterprises as well as high health protection and an innovative effect. Therefore, the question arises to what extent these goals have been achieved so far or c...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
| Published: |
De Gruyter
2023-09-01
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| Series: | Current Directions in Biomedical Engineering |
| Subjects: | |
| Online Access: | https://doi.org/10.1515/cdbme-2023-1051 |
| _version_ | 1797646351342764032 |
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| author | Sojka Karolina Sohrabi Keywan Gross Volker Scholtes Michael |
| author_facet | Sojka Karolina Sohrabi Keywan Gross Volker Scholtes Michael |
| author_sort | Sojka Karolina |
| collection | DOAJ |
| description | The MDR states the objectives of the law in the preface. There you will find, among other things, a consideration of small and medium-sized enterprises as well as high health protection and an innovative effect. Therefore, the question arises to what extent these goals have been achieved so far or can be achieved in the foreseeable future. To this end, a systematic literature review was conducted to present the perspectives of various stakeholders in the healthcare sector. Critical situations certainly arise for certain manufacturers, Notified Bodies and certain patient groups. The adopted extension of the transitional periods could be helpful but will not solve all problems. |
| first_indexed | 2024-03-11T15:01:21Z |
| format | Article |
| id | doaj.art-fc6e2fa501754193bf5df375d336f742 |
| institution | Directory Open Access Journal |
| issn | 2364-5504 |
| language | English |
| last_indexed | 2024-03-11T15:01:21Z |
| publishDate | 2023-09-01 |
| publisher | De Gruyter |
| record_format | Article |
| series | Current Directions in Biomedical Engineering |
| spelling | doaj.art-fc6e2fa501754193bf5df375d336f7422023-10-30T07:58:11ZengDe GruyterCurrent Directions in Biomedical Engineering2364-55042023-09-019120220510.1515/cdbme-2023-1051Reflection of the Medical Device RegulationSojka Karolina0Sohrabi Keywan1Gross Volker2Scholtes Michael3Faculity of Health Sciences - University of Applied Sciences, Giessen, GermanyFaculity of Health Sciences - University of Applied Sciences, Giessen, GermanyFaculity of Health Sciences - University of Applied Sciences, Giessen, GermanyFaculity of Health Sciences - University of Applied Sciences Giessen, Wiesenstraße 14, Giessen, GermanyThe MDR states the objectives of the law in the preface. There you will find, among other things, a consideration of small and medium-sized enterprises as well as high health protection and an innovative effect. Therefore, the question arises to what extent these goals have been achieved so far or can be achieved in the foreseeable future. To this end, a systematic literature review was conducted to present the perspectives of various stakeholders in the healthcare sector. Critical situations certainly arise for certain manufacturers, Notified Bodies and certain patient groups. The adopted extension of the transitional periods could be helpful but will not solve all problems.https://doi.org/10.1515/cdbme-2023-1051medical device regulationsocioeconomic impact |
| spellingShingle | Sojka Karolina Sohrabi Keywan Gross Volker Scholtes Michael Reflection of the Medical Device Regulation Current Directions in Biomedical Engineering medical device regulation socioeconomic impact |
| title | Reflection of the Medical Device Regulation |
| title_full | Reflection of the Medical Device Regulation |
| title_fullStr | Reflection of the Medical Device Regulation |
| title_full_unstemmed | Reflection of the Medical Device Regulation |
| title_short | Reflection of the Medical Device Regulation |
| title_sort | reflection of the medical device regulation |
| topic | medical device regulation socioeconomic impact |
| url | https://doi.org/10.1515/cdbme-2023-1051 |
| work_keys_str_mv | AT sojkakarolina reflectionofthemedicaldeviceregulation AT sohrabikeywan reflectionofthemedicaldeviceregulation AT grossvolker reflectionofthemedicaldeviceregulation AT scholtesmichael reflectionofthemedicaldeviceregulation |