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A Novel Method for Monitoring Notified Bodies Designated under The European Union Medical Device Regulation

Yıl 2024, Cilt: 28 Sayı: 3, 415 - 421, 23.12.2024
https://doi.org/10.19113/sdufenbed.1508221

Öz

Notified bodies, which perform conformity assessments, play a crucial role in protecting patient health and providing access to safety products on the market. The EU 2017/745 Medical Device Regulation (MDR) brings stricter rules and responsibilities for notified bodies. Designating authorities (DAs), who are also responsible for monitoring notified bodies, have not been provided with any guidance documents or written procedures. In this study, for the first time, we proposed a methodology aided by a digital system to monitor notified bodies effectively. We conducted a need analysis based on the MDR requirements and the relevant guidance documents, and we introduced a six-component technique for monitoring of the medical device notified bodies. Then, we identified the subcriteria of each component and created business activity diagrams for the main processes to monitor the notified bodies. There are now forty-eight notified bodies available under the MDR. Our monitoring approach consists of six steps that cover all NB-related activities, such as review of technical documentation assessment, personnel authorization, and surveillance of the certified product on the market. The proposed system complies with the MDR requirements and handles all critical performance indicators of NBs. The new MDR requirements for NBs also require an advanced monitoring system for DAs. This study focused on the critical points for monitoring NBs. Member states should implement the proposed methodology and the activity diagrams to have an efficient monitoring system in accordance with MDR requirements. A similar system can be used for monitoring of the other conformity assessment bodies.

Kaynakça

  • [1] Anonym, 2017. (EU) 2017/745 Medical Device Regulation. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745 (Accessed date: 20.05.2024).
  • [2] Anonym, 1990. Council Directive 90/385/EEC concerning active implantable medical devices. Official Journal of The European Communities, Luxembourg. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A31990L0385 (Accessed date: 20.05.2024).
  • [3] Anonym, 1993. Council Directive 93/42/EEC concerning medical devices. Official Journal of The European Communities, Luxembourg. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A31993L0042 (Accessed date: 20.05.2024).
  • [4] Anonym, The NANDO website. https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/notified-bodies_en (Accessed date: 20.05.2024).
  • [5] Anonym, MDCG Guidance documents. https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en (Accessed date: 20.05.2024).
  • [6] Anonym, The list of notified bodies under the MDR. https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notified-body-list?filter=legislationId:34,notificationStatusId:1 (Accessed date: 20.05.2024).
  • [7] Medvidovic, N., Rosenblum, D.S., Redmiles, D.F., Robbins, J.E. 2002. Modelling software architectures in the Unified Modelling Language [TOSEM]. ACM Trans Softw Eng Methodol;11(1):2–57.
  • [8] Anonym, NBOG 2017-2 Guidance on the Information Required for Conformity assessment bodies’ Personnel Involved in Conformity Assessment Activities. https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2017_2_nbog_bpg_en_0.pdf (Accessed date: 20.05.2024).
  • [9] Anonym, 2019. IAF MD 5:2019, International Accreditation Forum. https://iaf.nu/iaf_system/uploads/documents/IAF_MD5_Issue_4_Version_2_11112019.pdf (Accessed date: 20.05.2024).
  • [10] Anonym, MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation. 2019. https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_13_sampling_mdr_ivdr_en_0.pdf (Accessed date: 20.05.2024).
  • [11] Anonym, MDCG 2020-5 Clinical Evaluation – Equivalence. 2020. https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en_0.pdf (Accessed date: 20.05.2024).
  • [12] Anonym, MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. 2020. https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_6_guidance_sufficient_clinical_evidence_en_0.pdf (Accessed date: 20.05.2024).
  • [13] Anonym, MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. 2020. https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_7_guidance_pmcf_plan_template_en_0.pdf (Accessed date: 20.05.2024).
  • [14] Anonym, MDCG 2019-14 Explanatory note on MDR codes. 2019. https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_14_mdr_codes_en_0.pdf (Accessed date: 20.05.2024).
  • [15] Smith, J., Jones, K., Brown, M. 2023. European manufacturers' understanding of the Medical Device Regulation: A gap analysis. Medical Device Law Review, 32(2), 123-135.
  • [16] Garcia, P., Lopez, A., Sanchez, R. 2021. Financial impact of the Medical Device Regulation on European manufacturers: A comparative study. Health Economics, 40(5), 821-834.
  • [17] Davis, T., Miller, D. 2023. Challenges in conducting clinical investigations for novel medical devices under the new regulations. ClinicalTrials, 20(5), 456-470.
  • [18] Kearney, B., McDermott, O. 2023. The Challenges for Manufacturers of the Increased Clinical Evaluation in the European Medical Device Regulations: A Quantitative Study. Therapeutic Innovation & Regulatory Science, 1-14.
  • [19] Baines, R., Hoogendoorn, P., Stevens, S., Chatterjee, A., Ashall-Payne, L., Andrews, T., & Leigh, S. 2023. Navigating medical device certification: a qualitative exploration of barriers and enablers amongst innovators, notified bodies and other stakeholders. Therapeutic Innovation & Regulatory Science, 57(2), 238-250.
  • [20] Green, M., Williams, K. 2022. The potential benefits of new medical device regulations for patient safety: An analysis of the enhanced oversight and data collection requirements. International Journal of Technology Assessment in Healthcare, 38(2), 312-325.
  • [21] Farrugia, K. 2023. Designation and oversight of notified bodies in medical device regulatory sciences (Doctoral dissertation), 151s, Malta.

Avrupa Birliği Tıbbi Cihaz Yönetmeliği Kapsamında Yetkilendirilen Onaylanmış Kuruluşların İzlenmesi için Yeni Bir Yöntem

Yıl 2024, Cilt: 28 Sayı: 3, 415 - 421, 23.12.2024
https://doi.org/10.19113/sdufenbed.1508221

Öz

Uygunluk değerlendirmesi gerçekleştiren onaylanmış kuruluşlar, hasta sağlığının korunmasında ve piyasadaki güvenli ürünlere erişimin sağlanmasında çok önemli bir rol oynamaktadır. AB 2017/745 Tıbbi Cihaz Yönetmeliği (MDR), onaylanmış kuruluşlar için daha katı kurallar ve sorumluluklar getirmektedir. Onaylanmış kuruluşların izlenmesinden de sorumlu olan atama otoriteleri için herhangi bir rehber doküman veya yazılı prosedür yoktur. Bu çalışmada, ilk kez, onaylanmış kuruluşların etkin bir şekilde izlenmesi için dijital bir sistemle desteklenen bir metodoloji önerilmiştir. MDR gerekliliklerine ve ilgili rehber dokümanlara dayalı bir ihtiyaç analizi gerçekleştirilmiş ve tıbbi cihaz onaylanmış kuruluşlarının izlenmesi için altı bileşenli bir teknik ortaya koyulmuştur. Ardından, her bir bileşenin alt kriterleri belirlenmiş ve onaylanmış kuruluşların izlenmesine yönelik ana süreçler için iş aktivite diyagramları oluşturulmuştur. Şu anda MDR kapsamında kırk dokuz onaylanmış kuruluş bulunmaktadır. İzleme yaklaşımımız, teknik dokümantasyon değerlendirmesinin gözden geçirilmesi, personel yetkilendirmesi ve sertifikalı ürünün piyasada gözetimi gibi onaylanmış kuruluş ile ilgili tüm faaliyetleri kapsayan altı adımdan oluşmaktadır. Önerilen sistem MDR gereklilikleriyle uyumludur ve onaylanmış kuruluşların tüm kritik performans göstergelerini ele alır. Onaylanmış kuruluşlar için yeni MDR gereklilikleri, atama otoriterleri için de gelişmiş bir izleme sistemi gerektirmektedir. Bu çalışma onaylanmış kuruluşların izlenmesi için kritik noktalara odaklanmıştır. Üye devletler, MDR gerekliliklerine uygun etkin bir izleme sistemine sahip olmak için önerilen metodolojiyi ve faaliyet diyagramlarını uygulamalıdır. Benzer bir sistem diğer uygunluk değerlendirme kuruluşlarının izlenmesi için de kullanılabilir.

Kaynakça

  • [1] Anonym, 2017. (EU) 2017/745 Medical Device Regulation. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745 (Accessed date: 20.05.2024).
  • [2] Anonym, 1990. Council Directive 90/385/EEC concerning active implantable medical devices. Official Journal of The European Communities, Luxembourg. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A31990L0385 (Accessed date: 20.05.2024).
  • [3] Anonym, 1993. Council Directive 93/42/EEC concerning medical devices. Official Journal of The European Communities, Luxembourg. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A31993L0042 (Accessed date: 20.05.2024).
  • [4] Anonym, The NANDO website. https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/notified-bodies_en (Accessed date: 20.05.2024).
  • [5] Anonym, MDCG Guidance documents. https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en (Accessed date: 20.05.2024).
  • [6] Anonym, The list of notified bodies under the MDR. https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notified-body-list?filter=legislationId:34,notificationStatusId:1 (Accessed date: 20.05.2024).
  • [7] Medvidovic, N., Rosenblum, D.S., Redmiles, D.F., Robbins, J.E. 2002. Modelling software architectures in the Unified Modelling Language [TOSEM]. ACM Trans Softw Eng Methodol;11(1):2–57.
  • [8] Anonym, NBOG 2017-2 Guidance on the Information Required for Conformity assessment bodies’ Personnel Involved in Conformity Assessment Activities. https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2017_2_nbog_bpg_en_0.pdf (Accessed date: 20.05.2024).
  • [9] Anonym, 2019. IAF MD 5:2019, International Accreditation Forum. https://iaf.nu/iaf_system/uploads/documents/IAF_MD5_Issue_4_Version_2_11112019.pdf (Accessed date: 20.05.2024).
  • [10] Anonym, MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation. 2019. https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_13_sampling_mdr_ivdr_en_0.pdf (Accessed date: 20.05.2024).
  • [11] Anonym, MDCG 2020-5 Clinical Evaluation – Equivalence. 2020. https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en_0.pdf (Accessed date: 20.05.2024).
  • [12] Anonym, MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. 2020. https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_6_guidance_sufficient_clinical_evidence_en_0.pdf (Accessed date: 20.05.2024).
  • [13] Anonym, MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. 2020. https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_7_guidance_pmcf_plan_template_en_0.pdf (Accessed date: 20.05.2024).
  • [14] Anonym, MDCG 2019-14 Explanatory note on MDR codes. 2019. https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_14_mdr_codes_en_0.pdf (Accessed date: 20.05.2024).
  • [15] Smith, J., Jones, K., Brown, M. 2023. European manufacturers' understanding of the Medical Device Regulation: A gap analysis. Medical Device Law Review, 32(2), 123-135.
  • [16] Garcia, P., Lopez, A., Sanchez, R. 2021. Financial impact of the Medical Device Regulation on European manufacturers: A comparative study. Health Economics, 40(5), 821-834.
  • [17] Davis, T., Miller, D. 2023. Challenges in conducting clinical investigations for novel medical devices under the new regulations. ClinicalTrials, 20(5), 456-470.
  • [18] Kearney, B., McDermott, O. 2023. The Challenges for Manufacturers of the Increased Clinical Evaluation in the European Medical Device Regulations: A Quantitative Study. Therapeutic Innovation & Regulatory Science, 1-14.
  • [19] Baines, R., Hoogendoorn, P., Stevens, S., Chatterjee, A., Ashall-Payne, L., Andrews, T., & Leigh, S. 2023. Navigating medical device certification: a qualitative exploration of barriers and enablers amongst innovators, notified bodies and other stakeholders. Therapeutic Innovation & Regulatory Science, 57(2), 238-250.
  • [20] Green, M., Williams, K. 2022. The potential benefits of new medical device regulations for patient safety: An analysis of the enhanced oversight and data collection requirements. International Journal of Technology Assessment in Healthcare, 38(2), 312-325.
  • [21] Farrugia, K. 2023. Designation and oversight of notified bodies in medical device regulatory sciences (Doctoral dissertation), 151s, Malta.
Toplam 21 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Konular Tıbbi Cihazlar
Bölüm Makaleler
Yazarlar

Tuncay Bayrak 0000-0001-6826-4350

Yayımlanma Tarihi 23 Aralık 2024
Gönderilme Tarihi 1 Temmuz 2024
Kabul Tarihi 23 Ağustos 2024
Yayımlandığı Sayı Yıl 2024 Cilt: 28 Sayı: 3

Kaynak Göster

APA Bayrak, T. (2024). A Novel Method for Monitoring Notified Bodies Designated under The European Union Medical Device Regulation. Süleyman Demirel Üniversitesi Fen Bilimleri Enstitüsü Dergisi, 28(3), 415-421. https://doi.org/10.19113/sdufenbed.1508221
AMA Bayrak T. A Novel Method for Monitoring Notified Bodies Designated under The European Union Medical Device Regulation. Süleyman Demirel Üniv. Fen Bilim. Enst. Derg. Aralık 2024;28(3):415-421. doi:10.19113/sdufenbed.1508221
Chicago Bayrak, Tuncay. “A Novel Method for Monitoring Notified Bodies Designated under The European Union Medical Device Regulation”. Süleyman Demirel Üniversitesi Fen Bilimleri Enstitüsü Dergisi 28, sy. 3 (Aralık 2024): 415-21. https://doi.org/10.19113/sdufenbed.1508221.
EndNote Bayrak T (01 Aralık 2024) A Novel Method for Monitoring Notified Bodies Designated under The European Union Medical Device Regulation. Süleyman Demirel Üniversitesi Fen Bilimleri Enstitüsü Dergisi 28 3 415–421.
IEEE T. Bayrak, “A Novel Method for Monitoring Notified Bodies Designated under The European Union Medical Device Regulation”, Süleyman Demirel Üniv. Fen Bilim. Enst. Derg., c. 28, sy. 3, ss. 415–421, 2024, doi: 10.19113/sdufenbed.1508221.
ISNAD Bayrak, Tuncay. “A Novel Method for Monitoring Notified Bodies Designated under The European Union Medical Device Regulation”. Süleyman Demirel Üniversitesi Fen Bilimleri Enstitüsü Dergisi 28/3 (Aralık 2024), 415-421. https://doi.org/10.19113/sdufenbed.1508221.
JAMA Bayrak T. A Novel Method for Monitoring Notified Bodies Designated under The European Union Medical Device Regulation. Süleyman Demirel Üniv. Fen Bilim. Enst. Derg. 2024;28:415–421.
MLA Bayrak, Tuncay. “A Novel Method for Monitoring Notified Bodies Designated under The European Union Medical Device Regulation”. Süleyman Demirel Üniversitesi Fen Bilimleri Enstitüsü Dergisi, c. 28, sy. 3, 2024, ss. 415-21, doi:10.19113/sdufenbed.1508221.
Vancouver Bayrak T. A Novel Method for Monitoring Notified Bodies Designated under The European Union Medical Device Regulation. Süleyman Demirel Üniv. Fen Bilim. Enst. Derg. 2024;28(3):415-21.

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