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Thomas M Grupp Aesculap AG, Research & Development & Medical Scientific Affairs, Tuttlingen, Germany
Ludwig Maximilians University Munich, Department of Orthopaedic and Trauma Surgery, Musculoskeletal University Center Munich (MUM), Campus Grosshadern, Munich, Germany

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Sabine Rusch Aesculap AG, Research & Development & Medical Scientific Affairs, Tuttlingen, Germany

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Philippe Massin CMC Ambroise-Paré-Hartmann, Neuilly-sur-Seine, France

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Ashley Blom National Institute for Health Research Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol, Bristol, UK
Translational Health Sciences, Bristol Medical School, Musculoskeletal Research Unit, University of Bristol, Southmead Hospital, Bristol, UK

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Eduardo Garcia-Rey Hôpital Universitario La Paz-Idi Paz, Madrid, Spain
Centro de Investigación Biomédica en Red de Bioingeniería, Biomateriales y Nanomedicina, CIBER-BBN, Madrid, Spain

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Luca Cristofolini Department of Industrial Engineering, School of Engineering and Architecture, Alma Mater Studiorum - Università di Bologna, Bologna, Italy

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Dennis Janssen Radboud University Medical Center, Radboud Research Institute, Orthopaedic Research Lab, Nijmegen, the Netherlands

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Bernd Grimm Luxembourg Institute of Health, Human Motion, Orthopaedics, Sports Medicine & Digital Methods Group, Transversal Activities, Luxembourg

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Alexander Giurea Department of Orthopaedic Surgery, Medical University of Vienna, Vienna, Austria

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Marcus Jäger Department of Orthopaedics, Trauma & Reconstructive Surgery St. Marien Hospital Mülheim an der Ruhr & Chair of Orthopaedics and Trauma Surgery University of Duisburg–Essen, Essen, Germany

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Francesco Siccardi Medacta International SA, Research & Development & Medical Affairs, Castel San Pietro, Switzerland

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Søren Overgaard Copenhagen University Hospital, Department of Orthopaedic Surgery and Traumatology, Copenhagen, Denmark
Department of Clinical Medicine, Faculty of Health & Medical Sciences, University of Copenhagen, Copenhagen, Denmark

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  • The objectives of the 1st EFORT European Consensus on ‘Medical and Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices’ were foremost to focus on patient safety by establishing performance requirements for medical devices.

  • The 1st EFORT European Consensus applied an a priori-defined, modified Delphi methodology to produce unbiased, high-quality recommendation statements, confirmed by consensus voting of a European expert panel.

  • Intended key outcomes are practical guidelines justified by the current stage of knowledge and based on a broad European Expert Consensus, to maintain innovation and optimisation of orthopaedic devices within the boundaries of MDR 2017/745.

  • Twenty-one main research areas of relevance were defined relying on input from the EFORT IPSI WG1 ‘Introduction of Innovation’ recommendations and a related survey.

  • A modified Delphi approach with a preparatory literature review and work in small groups were used to prepare answers to the research questions in the form of 32 draft Consensus statements.

  • A Consensus Conference in a hybrid format, on-site in the Carl Gustav Carus University of Dresden was organised to further refine the draft statements and define consensus within the complete group of participants by final voting, intended to further quantify expert opinion knowledge.

  • The modified Delphi approach provides practical guidelines for hands-on orientation for orthopaedic surgeons, research institutes and laboratories, orthopaedic device manufacturers, patient representatives, Notified Bodies, National Institutes and authorities.

  • For the first time, initiated by the EFORT IPSI (WG1 ‘Introduction of Innovation’), knowledge of all related stakeholders was combined in the 1st EFORT European Consensus to develop guidelines and result in a comprehensive set of recommendations.

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Søren Overgaard Department of Orthopaedic Surgery and Traumatology, Copenhagen University Hospital, Copenhagen, Denmark
Department of Clinical Medicine, Faculty of Health & Medical Sciences, University of Copenhagen, Copenhagen, Denmark

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Thomas M Grupp 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

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Rob GHH Nelissen Department of Orthopaedics, Leiden University Medical Center, Leiden, the Netherlands
Technical University Delft, Delft, the Netherlands

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Luca Cristofolini Department of Industrial Engineering, School of Engineering and Architecture, Alma Mater Studiorum - Università di Bologna, Bologna, Italy

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Anne Lübbeke Division of Surgery and Traumatology, Geneva University Hospitals and University of Geneva, Switzerland
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK

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Marcus Jäger Department of Orthopaedics, Trauma & Reconstructive Surgery St. Marien Hospital Mülheim an der Ruhr & Chair of Orthopaedics and Trauma Surgery University of Duisburg–Essen, Essen, Germany

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Matthias Fink TÜV Süd Product Service GmbH, Clinical Centre of Excellence, Munich Germany

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Sabine Rusch Aesculap AG Research & Development & Medical Scientific Affairs, Tuttlingen, Germany

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Hassan Achakri Zimmer Biomet, Clinical, Regulatory & Quality Affairs, Winterthur, Switzerland

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Francesco Benazzo IUSS Pavia, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy

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Dario Bergadano Medacta International SA, Medical Affairs, Castel San Pietro, Switzerland

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Georg N Duda Julius Wolff Institute and Center for Muskuloskeletal Surgery, Berlin Institute of Health at Charité Universitätsmedizin Berlin, Germany

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Christian Kaddick EndoLab Mechanical Engineering GmbH, Riedering, Germany

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Volkmar Jansson Department of Orthopaedic and Trauma Surgery, Ludwig Maximilians University Munich, Musculoskeletal University Center Munich (MUM), Campus Grosshadern, Munich, Germany

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Klaus-Peter Günther University Clinic Carl Gustav Carus, Center for Orthopaedic & Trauma Surgery, Technical University Dresden, Dresden, Germany

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  • 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.

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