Publications on the subject of Quality of Clinical Data and why previous regulatory systems and processes failed to fulfil the expectations to deliver safe devices to the market.
- QoLA final report and publications.
Interesting Publications on implementation of MDR requirements and similar topics.
- Book „Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation“ by Dr. Wolfgang Ecker et al. https://www.bod.de/buchshop/clinical-evaluation-and-investigation-of-medical-devices-under-the-new-eu-regulation-wolfgang-ecker-9783751937665
• Dr Wolfgang Ecker, Chairman of the CIE, was in charge of the development of the new regulation during the entire time of this project. The book provides interpretation of the requirements, their implementation and links to applicable clauses in regulatory documents.
• A short YouTube Video including general considerations on adaptions necessary concerning clinical data due to new legal requirements and possible solutions.
Publications concerning Quality Registries
• International Intraocular Lens & Implant RegistryJ.T. HolladyInternational Intraocular Lens & Implant Registry – PubMed (nih.gov)https://journals.lww.com/jcrs/pages/default.aspx
• Use of Big Data by GermanvascBig Data | GermanVasc
• Outcomes From the Multicenter Italian Registry on Primary Endovascular Treatment of Aortoiliac Occlusive DiseaseG. Piffaretti et alOutcomes From the Multicenter Italian Registry on Primary Endovascular Treatment of Aortoiliac Occlusive Disease – PubMed (nih.gov)
• Report of the Hungarian Vascular Registry’s data of infrarenal aortic aneurysms (2010-2014)L. Hidi et al[Report of the Hungarian Vascular Registry’s data of infrarenal aortic aneurysms (2010-2014)] – PubMed nih.gov
• Are adverse events after carotid endarterectomy reported comparable in different registries?A.G. Taha et alAre adverse events after carotid endarterectomy reported comparable in different registries? – PubMed nih.gov
• European registers for total ankle replacementH. Kofoed et alEuropean registers for total ankle replacement – PubMed nih.gov
• Total ankle arthroplasty and national registers: What is the impact on scientific production?R D`Ambrosi et alTotal ankle arthroplasty and national registers: What is the impact on scientific production? – PubMed nih.gov
• German Total Ankle Replacement Register of the German Foot and Ankle Society (D. A. F.) – presentation of design and reliability of the data as well as first results]T. Kostuj et al[German Total Ankle Replacement Register of the German Foot and Ankle Society (D. A. F.) – presentation of design and reliability of the data as well as first results] – PubMed nih.gov
• [Hungarian Arthroplasty Registry]Börötz I at al[Hungarian Arthroplasty Registry] – PubMed nih.gov
Regulatory Documents:
• MEDDEV 2.7/1 rev 4DocsRoom – European Commission europa.eu
• Medical Device RegulationEUR-Lex – 32017R0745 – EN – EUR-Lex europa.eu
• IMDRFDocuments imdrf.org