Tom Melvin
Tom Melvin
Medical Officer, Health Products Regulatory Authority, Dublin, Republic of Ireland
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Marina Torre
Marina Torre
Engineer, Senior Researcher, Istituto Superiore di Sanità, Rome, Italy
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of co-operation. 1 In this context, two new regulations entered into force in Europe in May 2017, the Medical Device Regulation (MDR) 2 and the In Vitro Diagnostic Device Regulation (IVDR). 3 These regulations will replace the current
Anne Lübbeke
Anne Lübbeke
Division of Orthopaedic Surgery and Traumatology, Geneva University Hospitals and University of Geneva, Switzerland
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
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Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
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James A. Smith
James A. Smith
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
National Institute for Health Research Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford, UK
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National Institute for Health Research Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford, UK
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Daniel Prieto-Alhambra
Daniel Prieto-Alhambra
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
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Andrew J. Carr
Andrew J. Carr
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
National Institute for Health Research Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford, UK
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National Institute for Health Research Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford, UK
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outcomes and economic influence. European regulations have become stricter, and US regulatory approaches have been reformed. 11 The new EU medical device regulation, adopted in 2017, will be fully in force in May 2021. This will require substantial
Alan G. Fraser
Alan G. Fraser
Department of Cardiology, University Hospital of Wales, Cardiff, UK
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Rob G.H.H. Nelissen
Rob G.H.H. Nelissen
Department of Orthopaedics, Leiden University Medical Center, Leiden, Netherlands
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Per Kjærsgaard-Andersen
Per Kjærsgaard-Andersen
Department of Orthopaedics, Vejle Hospital, South Danish University, Vejle, Denmark
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Piotr Szymański
Piotr Szymański
Centre of Postgraduate Medical Education, MSWiA Central Clinical Hospital, Warsaw, Poland
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Tom Melvin
Tom Melvin
Healthcare Products Regulatory Authority, Earlsfort Terrace, Dublin 2, Ireland
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Paul Piscoi
Paul Piscoi
Health Technology Unit B6, Directorate General for Health (DG SANTE), European Commission, Brussels, Belgium
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On behalf of the CORE–MD Investigators (see Appendix)
On behalf of the CORE–MD Investigators (see Appendix)
Alan Fraser, Piotr Szymański, Chris Gale, Aldo Maggioni, Elisabetta Zanon, Christina Dimopoulou, Cinzia Ceccarelli, Polyxeni Vairami, Anett Ruszanov, Per Kjærsgaard-Andersen, Rob Nelissen, Adrian Ott, Elizabeth Macintyre, Loredana Simulescu, Marieke Meijer, Berthold Koletzko, Sarah Wieczorek, Adamos Hadjipanayis, Stefano Del Torso, Perla Marang-van de Mheen, Lotje Hoogervorst, Ewout W. Steyerberg, Bas Penning De Vries, Peter McCulloch, Martin Landray, Daniel Prieto Alhambra, James Smith, Anne Lubbeke-Wolf, Stefan James, Sergio Buccheri, Robert Byrne, Laurna McGovern, Stephan Windecker, Andre Frenk, Georgios Siontis, Christoph Stettler, Arjola Bano, Lia Bally, Frank E. Rademakers, Jan D‘hooge, Anton Vedder, Elisabetta Biasin, Erik Kamenjasevic, Petra Schnell-Inderst, Felicitas Kühne, Ola Rolfson, Joel Jakobsson, Amanda Tornsö, Enrico G. Caiani, Lorenzo Gianquintieri, Cinzia Cappiello, Maristella Matera, Tom Melvin, Niall MacAleenan, Ria Mahon, Michèle Meagher, Gearóid McGauran, Thomas Wejs Møller, Ann-Sofie Sonne Holm-Schou, Jan Szulc, Robert E. Geertsma, Jantine W.P.M. van Baal, Joëlle M. Hoebert, Susana L.F. Cabaço, Paola Laricchiuta, Marina Torre, Filippo Boniforti, Eugenio Carrani, Stefania Ceccarelli, Claudia Wild, Sabine Ettinger, Juan Antonio Blasco Amaro, Juan Carlos Rejón Parrilla, Agnieszka Dobrzynska, David Epstein, Valentina Strammiello, Hannes Jarke, Kaisa Immonen, Françoise Schlemmer, Sabina Hoekstra, Marianna Mastroroberto, Christoph Ziskoven, Michael Hahn, Erman Melikyan, Richard Holborow, Suzanne Halliday, Alexey Shiryaev, Gero Viola, Harry van Vugt
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Introduction Regulations concerning medical devices are shared across the European Union (EU) but verification that manufacturers conform to their requirements is devolved to independent notified bodies overseen by their national regulatory
Anne Lübbeke
Anne Lübbeke
Division of Orthopaedic Surgery & Traumatology, Geneva University Hospitals and University of Geneva, Switzerland
Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK
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Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK
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Christophe Combescure
Christophe Combescure
Division of Clinical Epidemiology, Geneva University Hospitals and University of Geneva, Switzerland
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Christophe Barea
Christophe Barea
Division of Orthopaedic Surgery & Traumatology, Geneva University Hospitals and University of Geneva, Switzerland
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Amanda Inez Gonzalez
Amanda Inez Gonzalez
Division of Orthopaedic Surgery & Traumatology, Geneva University Hospitals and University of Geneva, Switzerland
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Keith Tucker
Keith Tucker
Chair Orthopaedic Data Evaluation Panel, UK
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Per Kjærsgaard-Andersen
Per Kjærsgaard-Andersen
Center for Adult Hip and Knee Reconstruction, Department of Orthopaedics, South Danish University, Vejle Hospital, Denmark
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Tom Melvin
Tom Melvin
School of Medicine, Trinity College Dublin, Ireland
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Alan G Fraser
Alan G Fraser
Department of Cardiology, University Hospital of Wales, Cardiff, UK
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Rob Nelissen
Rob Nelissen
Department of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands
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James A Smith
James A Smith
Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK
National Institute for Health Research Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford, UK
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National Institute for Health Research Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford, UK
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the very few detailed analyses on evidence for medical devices being published. The Medical Device Regulation (MDR) ((EU) 2017/745) is changing the requirements for certification (CE-marking) of implantable medical devices in Europe. The MDR will
Ann Alriksson-Schmidt
Ann Alriksson-Schmidt
Lund University, Department of Clinical Sciences, Sweden
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Jonas Ranstam
Jonas Ranstam
Mdas AB, Sweden
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Otto Robertsson
Otto Robertsson
Lund University, Department of Clinical Sciences, Sweden
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Lars Lidgren
Lars Lidgren
Lund University, Department of Clinical Sciences, Sweden
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Introduction In the wake of the Poly Implant Prosthèse breast implant and the metal-on-metal incidents, the inherent flaws of European regulatory systems for medical products and devices have been highlighted once again. 1 In lieu of the
Andrew Carr
Andrew Carr
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
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surgical devices. On 20 July 2011 the US House Energy and Commerce sub-committee on oversight and investigations held a hearing on ‘medical device regulation: impact on American patients’ innovation and jobs’. Congressman Chris Starns was the sub
Thomas M Grupp
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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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
Sabine Rusch
Aesculap AG, Research & Development & Medical Scientific Affairs, Tuttlingen, Germany
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Philippe Massin
Philippe Massin
CMC Ambroise-Paré-Hartmann, Neuilly-sur-Seine, France
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Ashley Blom
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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Translational Health Sciences, Bristol Medical School, Musculoskeletal Research Unit, University of Bristol, Southmead Hospital, Bristol, UK
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Eduardo Garcia-Rey
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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Centro de Investigación Biomédica en Red de Bioingeniería, Biomateriales y Nanomedicina, CIBER-BBN, Madrid, Spain
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Luca Cristofolini
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
Dennis Janssen
Radboud University Medical Center, Radboud Research Institute, Orthopaedic Research Lab, Nijmegen, the Netherlands
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Bernd Grimm
Bernd Grimm
Luxembourg Institute of Health, Human Motion, Orthopaedics, Sports Medicine & Digital Methods Group, Transversal Activities, Luxembourg
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Alexander Giurea
Alexander Giurea
Department of Orthopaedic Surgery, Medical University of Vienna, Vienna, Austria
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Marcus Jäger
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
Francesco Siccardi
Medacta International SA, Research & Development & Medical Affairs, Castel San Pietro, Switzerland
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Søren Overgaard
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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Department of Clinical Medicine, Faculty of Health & Medical Sciences, University of Copenhagen, Copenhagen, Denmark
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opinions and mindsets in relation to IPSI, as well as the clinical introduction of medical devices under the Medical Device Regulation. The results were presented at the 1st EFORT Virtual Congress (Oct 28–30, 2020) and served as input for the definition of
Søren Overgaard
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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Department of Clinical Medicine, Faculty of Health & Medical Sciences, University of Copenhagen, Copenhagen, Denmark
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Thomas M Grupp
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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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
Rob GHH Nelissen
Department of Orthopaedics, Leiden University Medical Center, Leiden, the Netherlands
Technical University Delft, Delft, the Netherlands
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Technical University Delft, Delft, the Netherlands
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Luca Cristofolini
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
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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Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK
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Marcus Jäger
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
Matthias Fink
TÜV Süd Product Service GmbH, Clinical Centre of Excellence, Munich Germany
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Sabine Rusch
Sabine Rusch
Aesculap AG Research & Development & Medical Scientific Affairs, Tuttlingen, Germany
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Hassan Achakri
Hassan Achakri
Zimmer Biomet, Clinical, Regulatory & Quality Affairs, Winterthur, Switzerland
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Francesco Benazzo
Francesco Benazzo
IUSS Pavia, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy
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Dario Bergadano
Dario Bergadano
Medacta International SA, Medical Affairs, Castel San Pietro, Switzerland
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Georg N Duda
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
Christian Kaddick
EndoLab Mechanical Engineering GmbH, Riedering, Germany
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Volkmar Jansson
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
Klaus-Peter Günther
University Clinic Carl Gustav Carus, Center for Orthopaedic & Trauma Surgery, Technical University Dresden, Dresden, Germany
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clinical and pre-clinical evaluation of the innovation in terms of insufficient validation of clinical outcomes and side effects. This stresses that the new Medical Device Regulation (MDR) is warranted. Introduction of new treatment techniques, modified
Geke A. W. Denissen
Geke A. W. Denissen
Landelijke Registratie Orthopedische Implantaten (Dutch Arthroplasty Register), ’s Hertogenbosch, The Netherlands
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Liza N. van Steenbergen
Liza N. van Steenbergen
Landelijke Registratie Orthopedische Implantaten (Dutch Arthroplasty Register), ’s Hertogenbosch, The Netherlands
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Wouter T. Lollinga
Wouter T. Lollinga
Landelijke Registratie Orthopedische Implantaten (Dutch Arthroplasty Register), ’s Hertogenbosch, The Netherlands
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Nico J. J. Verdonschot
Nico J. J. Verdonschot
Dept. of Biomechanics, Radboud University Medical Center, Nijmegen, The Netherlands
Department of Biomechanical Engineering, University of Twente, Enschede, The Netherlands
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Department of Biomechanical Engineering, University of Twente, Enschede, The Netherlands
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Berend W. Schreurs
Berend W. Schreurs
Landelijke Registratie Orthopedische Implantaten (Dutch Arthroplasty Register), ’s Hertogenbosch, The Netherlands
Dept. of Orthopaedics, Radboud University Medical Center, Nijmegen, The Netherlands
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Dept. of Orthopaedics, Radboud University Medical Center, Nijmegen, The Netherlands
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Rob G. H. H. Nelissen
Rob G. H. H. Nelissen
Landelijke Registratie Orthopedische Implantaten (Dutch Arthroplasty Register), ’s Hertogenbosch, The Netherlands
Dept. of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands
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Dept. of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands
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. The Medical Device Regulation (MDR) is the new European legislation to improve patient safety in the European Union for all medical devices. In the MDR, new regulations on medical devices were adopted and will become effective after a transitional
Richard N de Steiger
Richard N de Steiger
Australian Orthopaedic Association National Joint Replacement Registry, SAHMRI, Adelaide, Australia
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Brian R Hallstrom
Brian R Hallstrom
Michigan Arthroplasty Registry Collaborative Quality Initiative University of Michigan, Department of Orthopaedic Surgery, Ann Arbor, Michigan, USA
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Anne Lübbeke
Anne Lübbeke
Geneva Arthroplasty Registry, Geneva University Hospitals Rue Gabrielle-Perret-Gentil 4 CH-1211 Geneva, Switzerland
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Elizabeth W Paxton
Elizabeth W Paxton
Surgical Outcomes and Analysis Unit, Kaiser Permanente National Implant Registries 8954 Rio San Diego Drive, Suite, San Diego, California, USA
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Liza N van Steenbergen
Liza N van Steenbergen
Dutch Arthroplasty Register (Landelijke Registratie Orthopedische Implantaten (LROI)), Bruistensingel 230 | 5232 AD ’s-Hertogenbosch, The Netherlands
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Mark Wilkinson
Mark Wilkinson
Department of Oncology and Metabolism, University of Sheffield, Beech Hill Road, Sheffield, United Kingdom
National Joint Replacement for England, Wales, Northern Ireland, Isle of Man and the States of Guernsey (NJR)
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National Joint Replacement for England, Wales, Northern Ireland, Isle of Man and the States of Guernsey (NJR)
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coordinating this effort with the Advanced Medical Technology Associate (AdvaMed), the trade group of manufacturers of medical implants, to ensure consistent communication across individual manufacturers. The Kaiser Permanente Registry has a medical device
