Introduction of innovations in joint arthroplasty: Recommendations from the ‘EFORT implant and patient safety initiative’
With the implementation of the new MDR 2017/745 by the European Parliament, more robust clinical and pre-clinical data will be required due to a more stringent approval process. The EFORT Implant and Patient Safety Initiative WG1 ‘Introduction of Innovation’, combined knowledge of orthopaedic surge...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Bioscientifica
2023-07-01
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| Series: | EFORT Open Reviews |
| Subjects: | |
| Online Access: | https://eor.bioscientifica.com/view/journals/eor/8/7/EOR-23-0072.xml |
| _version_ | 1827908205940834304 |
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| author | Søren Overgaard Thomas M Grupp Rob GHH Nelissen Luca Cristofolini Anne Lübbeke Marcus Jäger Matthias Fink Sabine Rusch Hassan Achakri Francesco Benazzo Dario Bergadano Georg N Duda Christian Kaddick Volkmar Jansson Klaus-Peter Günther |
| author_facet | Søren Overgaard Thomas M Grupp Rob GHH Nelissen Luca Cristofolini Anne Lübbeke Marcus Jäger Matthias Fink Sabine Rusch Hassan Achakri Francesco Benazzo Dario Bergadano Georg N Duda Christian Kaddick Volkmar Jansson Klaus-Peter Günther |
| author_sort | Søren Overgaard |
| collection | DOAJ |
| description | With the implementation of the new MDR 2017/745 by the European Parliament, more robust clinical and pre-clinical data will be required due to a more stringent approval process.
The EFORT Implant and Patient Safety Initiative WG1 ‘Introduction of Innovation’, combined knowledge of orthopaedic surgeons, research institutes, orthopaedic device manufacturers, patient representatives and regulatory authorities to develop a comprehensive set of recommendations for the introduction of innovations in joint arthroplasty within the boundaries of MDR 2017/745.
Recommendations have been developed to address key questions about pre-clinical and clinical requirements for the introduction of new implants and implant-related instrumentation with the participation of a steering group, invited by the EFORT Board in dialogue with representatives from European National Societies and Speciality Societies.
Different degrees of novelty and innovation were described and agreed on in relation to when surgeons can start, using implants and implant-related instrumentation routinely.
Before any clinical phase of a new implant, following the pre-market clinical investigation or the equivalent device PMCF pathway, it is a common understanding that all appropriate pre-clinical testing (regulatory mandatory and evident state of the art) – which has to be considered for a specific device – has been successfully completed.
Once manufacturers receive the CE mark for a medical device, it can be used in patients routinely when a clinical investigation has been conducted to demonstrate the conformity of devices according to MDR Article 62 or full equivalence for the technical, biological and clinical characteristics has been demonstrated (MDR, Annex XIV, Part A, 3.) and a PMCF study has been initiated. |
| first_indexed | 2024-03-13T01:18:43Z |
| format | Article |
| id | doaj.art-a5cf775545964c91bb2f720769199354 |
| institution | Directory Open Access Journal |
| issn | 2058-5241 |
| language | English |
| last_indexed | 2024-03-13T01:18:43Z |
| publishDate | 2023-07-01 |
| publisher | Bioscientifica |
| record_format | Article |
| series | EFORT Open Reviews |
| spelling | doaj.art-a5cf775545964c91bb2f7207691993542023-07-05T07:07:39ZengBioscientificaEFORT Open Reviews2058-52412023-07-0187509521https://doi.org/10.1530/EOR-23-0072Introduction of innovations in joint arthroplasty: Recommendations from the ‘EFORT implant and patient safety initiative’Søren Overgaard0Thomas M Grupp1Rob GHH Nelissen2Luca Cristofolini3Anne Lübbeke4Marcus Jäger5Matthias Fink6Sabine Rusch7Hassan Achakri8Francesco Benazzo9Dario Bergadano10Georg N Duda11Christian Kaddick12Volkmar Jansson13Klaus-Peter Günther14Department of Orthopaedic Surgery and Traumatology, Copenhagen University Hospital, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health & Medical Sciences, University of Copenhagen, Copenhagen, Denmark Aesculap AG Research & Development & Medical Scientific Affairs, Tuttlingen, Germany; Department of Orthopaedic and Trauma Surgery, Ludwig Maximilians University Munich, Musculoskeletal University Center Munich (MUM), Campus Grosshadern, Munich, Germany Department of Orthopaedics, Leiden University Medical Center, Leiden, the Netherlands; Technical University Delft, Delft, the Netherlands Department of Industrial Engineering, School of Engineering and Architecture, Alma Mater Studiorum - Università di Bologna, Bologna, ItalyDivision of Surgery and Traumatology, Geneva University Hospitals and University of Geneva, Switzerland; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK Department of Orthopaedics, Trauma & Reconstructive Surgery St. Marien Hospital Mülheim an der Ruhr & Chair of Orthopaedics and Trauma Surgery University of Duisburg–Essen, Essen, GermanyTÜV Süd Product Service GmbH, Clinical Centre of Excellence, Munich GermanyAesculap AG Research & Development & Medical Scientific Affairs, Tuttlingen, GermanyZimmer Biomet, Clinical, Regulatory & Quality Affairs, Winterthur, SwitzerlandIUSS Pavia, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, ItalyMedacta International SA, Medical Affairs, Castel San Pietro, SwitzerlandJulius Wolff Institute and Center for Muskuloskeletal Surgery, Berlin Institute of Health at Charité Universitätsmedizin Berlin, GermanyEndoLab Mechanical Engineering GmbH, Riedering, GermanyDepartment of Orthopaedic and Trauma Surgery, Ludwig Maximilians University Munich, Musculoskeletal University Center Munich (MUM), Campus Grosshadern, Munich, GermanyUniversity Clinic Carl Gustav Carus, Center for Orthopaedic & Trauma Surgery, Technical University Dresden, Dresden, GermanyWith the implementation of the new MDR 2017/745 by the European Parliament, more robust clinical and pre-clinical data will be required due to a more stringent approval process. The EFORT Implant and Patient Safety Initiative WG1 ‘Introduction of Innovation’, combined knowledge of orthopaedic surgeons, research institutes, orthopaedic device manufacturers, patient representatives and regulatory authorities to develop a comprehensive set of recommendations for the introduction of innovations in joint arthroplasty within the boundaries of MDR 2017/745. Recommendations have been developed to address key questions about pre-clinical and clinical requirements for the introduction of new implants and implant-related instrumentation with the participation of a steering group, invited by the EFORT Board in dialogue with representatives from European National Societies and Speciality Societies. Different degrees of novelty and innovation were described and agreed on in relation to when surgeons can start, using implants and implant-related instrumentation routinely. Before any clinical phase of a new implant, following the pre-market clinical investigation or the equivalent device PMCF pathway, it is a common understanding that all appropriate pre-clinical testing (regulatory mandatory and evident state of the art) – which has to be considered for a specific device – has been successfully completed. Once manufacturers receive the CE mark for a medical device, it can be used in patients routinely when a clinical investigation has been conducted to demonstrate the conformity of devices according to MDR Article 62 or full equivalence for the technical, biological and clinical characteristics has been demonstrated (MDR, Annex XIV, Part A, 3.) and a PMCF study has been initiated.https://eor.bioscientifica.com/view/journals/eor/8/7/EOR-23-0072.xmlefort implant & patient safety initiativerecommendations ipsi wg1 introduction of innovationnew implants and implant-related instrumentationjoint arthroplastymedical device regulation mdr 2017/745 |
| spellingShingle | Søren Overgaard Thomas M Grupp Rob GHH Nelissen Luca Cristofolini Anne Lübbeke Marcus Jäger Matthias Fink Sabine Rusch Hassan Achakri Francesco Benazzo Dario Bergadano Georg N Duda Christian Kaddick Volkmar Jansson Klaus-Peter Günther Introduction of innovations in joint arthroplasty: Recommendations from the ‘EFORT implant and patient safety initiative’ EFORT Open Reviews efort implant & patient safety initiative recommendations ipsi wg1 introduction of innovation new implants and implant-related instrumentation joint arthroplasty medical device regulation mdr 2017/745 |
| title | Introduction of innovations in joint arthroplasty: Recommendations from the ‘EFORT implant and patient safety initiative’ |
| title_full | Introduction of innovations in joint arthroplasty: Recommendations from the ‘EFORT implant and patient safety initiative’ |
| title_fullStr | Introduction of innovations in joint arthroplasty: Recommendations from the ‘EFORT implant and patient safety initiative’ |
| title_full_unstemmed | Introduction of innovations in joint arthroplasty: Recommendations from the ‘EFORT implant and patient safety initiative’ |
| title_short | Introduction of innovations in joint arthroplasty: Recommendations from the ‘EFORT implant and patient safety initiative’ |
| title_sort | introduction of innovations in joint arthroplasty recommendations from the efort implant and patient safety initiative |
| topic | efort implant & patient safety initiative recommendations ipsi wg1 introduction of innovation new implants and implant-related instrumentation joint arthroplasty medical device regulation mdr 2017/745 |
| url | https://eor.bioscientifica.com/view/journals/eor/8/7/EOR-23-0072.xml |
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