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Tom Melvin Medical Officer, Health Products Regulatory Authority, Dublin, Republic of Ireland

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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

Article Type:
Review Article
Category:
General Orthopaedics
DOI:
https://doi.org/10.1302/2058-5241.4.180061
Volume/Issue:
Volume 4: Issue 6
Open access
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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Christophe Combescure Division of Clinical Epidemiology, Geneva University Hospitals and University of Geneva, Switzerland

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Christophe Barea Division of Orthopaedic Surgery & Traumatology, Geneva University Hospitals and University of Geneva, Switzerland

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Amanda Inez Gonzalez Division of Orthopaedic Surgery & Traumatology, Geneva University Hospitals and University of Geneva, Switzerland

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Keith Tucker Chair Orthopaedic Data Evaluation Panel, UK

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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 School of Medicine, Trinity College Dublin, Ireland

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Alan G Fraser Department of Cardiology, University Hospital of Wales, Cardiff, UK

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Rob Nelissen Department of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands

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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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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

Article Type:
Systematic Review
Category:
General Orthopaedics
DOI:
https://doi.org/10.1530/EOR-23-0024
Volume/Issue:
Volume 8: Issue 11
Open access
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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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

Article Type:
Review Article
Category:
General Orthopaedics
DOI:
https://doi.org/10.1530/EOR-23-0054
Volume/Issue:
Volume 8: Issue 7
Open access
Alan G. Fraser Department of Cardiology, University Hospital of Wales, Cardiff, UK

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Rob G.H.H. Nelissen Department of Orthopaedics, Leiden University Medical Center, Leiden, Netherlands

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Per Kjærsgaard-Andersen Department of Orthopaedics, Vejle Hospital, South Danish University, Vejle, Denmark

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Piotr Szymański Centre of Postgraduate Medical Education, MSWiA Central Clinical Hospital, Warsaw, Poland

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Tom Melvin Healthcare Products Regulatory Authority, Earlsfort Terrace, Dublin 2, Ireland

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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) 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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agencies (or ‘competent authorities’). The role of the European Commission is to implement the Medical Device Regulation (MDR) 1 together with the national regulatory agencies. Unlike some other jurisdictions worldwide, however, it lacks its own central

Article Type:
Review Article
Category:
General Orthopaedics
DOI:
https://doi.org/10.1302/2058-5241.6.210081
Volume/Issue:
Volume 6: Issue 10
Open access
Søren Overgaard Scientific Chair EFORT

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Phillippe Neyret Chair of VEC 2020, EFORT President 2019/2020

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Klaus-Peter Günther EFORT President 2020/2021

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Li Felländer-Tsai EFORT First Vice President

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discuss the clinically relevant issues of ‘The New Implant – Consequences of Medical Device Regulation’ and ‘MDR: How to Handle New Problems with Old Implants’. The VEC educational programme will be Continuing Medical Education Institute (CME

Article Type:
Editorial
Category:
Research
DOI:
https://doi.org/10.1302/2058-5241.5.200300
Volume/Issue:
Volume 5: Issue 8
Open access
Geke A. W. Denissen Landelijke Registratie Orthopedische Implantaten (Dutch Arthroplasty Register), ’s Hertogenbosch, The Netherlands

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Liza N. van Steenbergen Landelijke Registratie Orthopedische Implantaten (Dutch Arthroplasty Register), ’s Hertogenbosch, The Netherlands

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Wouter T. Lollinga Landelijke Registratie Orthopedische Implantaten (Dutch Arthroplasty Register), ’s Hertogenbosch, The Netherlands

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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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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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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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. 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

Article Type:
Review Article
Category:
General Orthopaedics
DOI:
https://doi.org/10.1302/2058-5241.4.180063
Volume/Issue:
Volume 4: Issue 6
Open access
Maria Moralidou Institute of Orthopaedics and Musculoskeletal Science, University College London and the Royal National Orthopaedic Hospital, Stanmore, UK

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Anna Di Laura Institute of Orthopaedics and Musculoskeletal Science, University College London and the Royal National Orthopaedic Hospital, Stanmore, UK

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Johann Henckel Institute of Orthopaedics and Musculoskeletal Science, University College London and the Royal National Orthopaedic Hospital, Stanmore, UK

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Harry Hothi Institute of Orthopaedics and Musculoskeletal Science, University College London and the Royal National Orthopaedic Hospital, Stanmore, UK

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Alister J. Hart Institute of Orthopaedics and Musculoskeletal Science, University College London and the Royal National Orthopaedic Hospital, Stanmore, UK

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after 2012 ( Fig. 2 ). The increasing trend of evidence regarding 3D planning may be affected by the introduction of European Medical Device Regulations, which intend to impose stricter rules on orthopaedic implants and software, to strengthen surgical

Article Type:
Review Article
Category:
Hip
DOI:
https://doi.org/10.1302/2058-5241.5.200046
Volume/Issue:
Volume 5: Issue 12
Open access
M M Morlock Institute of Biomechanics, TUHH Hamburg University of Technology, Hamburg, Germany

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E Gomez-Barrena Department of Orthopaedic Surgery and Traumatology, Universidad Autónoma de Madrid, Madrid, Spain

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D C Wirtz Department of Orthopaedics and Traumatology, University Hospital Bonn, Bonn, Germany

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A Hart London Implant Retrieval Centre, Royal National Orthopaedic Hospital, Stanmore, UK

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J P Kretzer Department of Orthopaedic Surgery, Heidelberg University Hospital, Heidelberg, Germany

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only solution is a well-defined clinical evaluation investigating the safety and functionality of the product. This aspect is now regulated by the Medical Device Regulation (MDR) ( 12 ), which took effect in 2021 and replaced the Medical Device

Article Type:
Review Article
Category:
General Orthopaedics
DOI:
https://doi.org/10.1530/EOR-22-0033
Volume/Issue:
Volume 7: Issue 6
Open access
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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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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Daniel Prieto-Alhambra Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK

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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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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

Article Type:
Review Article
Category:
General Orthopaedics
DOI:
https://doi.org/10.1302/2058-5241.6.200094
Volume/Issue:
Volume 6: Issue 3
Open access
Arya Nicum Institute of Orthopaedics and Musculoskeletal Science, University College London, UK

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Harry Hothi Royal National Orthopaedic Hospital, Stanmore, UK.
Department of Mechanical Engineering, University College London, UK

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Johann Henckel Royal National Orthopaedic Hospital, Stanmore, UK.

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Anna di Laura Royal National Orthopaedic Hospital, Stanmore, UK.
Department of Mechanical Engineering, University College London, UK

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Klaus Schlueter-Brust Department of Orthopaedic Surgery, St. Franziskus Hospital Köln, Köln, Germany

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Alister Hart Institute of Orthopaedics and Musculoskeletal Science, University College London, UK
Royal National Orthopaedic Hospital, Stanmore, UK.
Cleveland Clinic London, London, UK

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. Similarly, the guidance provided by the EU Medical Device Regulations (MDR) has also been criticised for its lack of clarity and harshness. A survey involving employees of medical device manufacturers in Germany was conducted by the EU MDR, before and after

Article Type:
Review Article
Category:
Hip
DOI:
https://doi.org/10.1530/EOR-23-0182
Volume/Issue:
Volume 9: Issue 9
Open access