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Issue II - August 2023

1st EFORT European Consensus

on Medical & Scientific Research Requirements

for the Clinical Introduction of Artificial Joint Arthroplasty Devices

Orthopaedic and Traumatology innovations have improved care for musculoskeletal disorders and injuries, with new implants, techniques, and research improving patient outcomes.

However, the regulatory framework lacks clarity, creating the need for understanding to ensure safety in introducing new implants. Through the EFORT Implant Patient & Staff Safety Initiative (IPSSI) recommendations were issued for developing, implementing, and disseminating innovation in arthroplasty, creating practical guidelines for stakeholders.

1st EFORT European Consensus book

The intended key outcomes of this 1st EFORT European Consensus are consented, practical pathways to maintain innovation and optimisation of orthopaedic products and workflows within the boundaries of MDR 2017/745.

Recently an article published in EFORT Open Reviews details the background, the Delphi methodology and the consensus process.

We would like to acknowledge and thank the Scientific Committee members, all International Expert Delegates, the Delegates from European National & Specialty Societies and the Editorial Team for their outstanding contributions and support during this EFORT European Consensus.


The Autumn 2023 Agenda

The project called EFORT Fora, launched in 2002, aims at organising specific EFORT symposia during the annual congresses of our member National Societies.

In recent years the EFORT Fora have enjoyed a very high scientific level and provided an excellent exchange between National Societies and EFORT.

Find all upcoming EFORT Fora taking place in Autumn 2023:

28 September 2023

SECOT Annual Congress 

Salamanca, Spain

EFORT Forum:

Complications in Forefoot Surgery

06 October 2023

HAOST Annual Congress

Athens, Greece

EFORT Forum:

Severe Injuries

of the Elbow

20 October 2023

SOROT Annual Congress

Sinaia, Romania

EFORT Forum:

A New Paradigm in

Joint Replacement


25 October 2023

DGOU Annual Congress

Berlin, Germany

EFORT Forum:

(Combined Session) Periprosthetic Fractures


02 November 2023 

TOTBID Annual Congress

Antalya, Turkey

EFORT Forum:

Common Fractures Around the Shoulder


02 November 2023 

SPOT Annual Congress

Vilamoura, Portugal

EFORT Forum: Building the Future in Paediatric Trauma // Tips & Tricks


10 November 2023 

SIOT Annual Congress

Rome, Italy

EFORT Forum:

Future Perspectives of

Uni and Total Knee Replacement


13 November 2023 

SOFCOT Annual Congress

Paris, France

EFORT Forum: Evolution in Adulthood of Ligamentoplasties Performed in Children and Adolescents


eScience Webcast highlights

This month's selection from EFORT comprehensive digital library

comprised of +17,900 scientific sessions recorded

3D Printing For Patient Special Implants In Musculoskeletal Oncology

by Daniel Kotrych

How To Do A Biologic Reconstruction In Acetabular Dysplasia In Primary THA

by Jochen Hofstaetter

The Importance Of Multidisciplinarity In Modern Orthopaedic Oncology: An Overview

by Andrea Angelini



Systematic Review of Cardiovascular and Orthopaedic Registries:

New publication

The International Journal of Health Policy and Management has recently published Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review written by Lotje A. Hoogervorst, Timon H. Geurkink, Anne Lübbeke, Sergio Buccheri, Jan W. Schoones, Marina Torre, Paola Laricchiuta, Paul Piscoi, Alma B. Pedersen, Chris P. Gale, James A. Smith, Aldo P. Maggioni, Stefan James, Alan G. Fraser, Rob G.H.H. Nelissen, Perla J. Marang-van de Mheen.

The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformité Européenne (CE) marking. 

The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) Project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes.

Regional, national and multi-country European cardiovascular (coronary stents and valve repair/replacement) and orthopaedic (hip/knee prostheses) registries were identified using a systematic literature search. Annual reports, peer-reviewed publications, and websites were reviewed to extract publicly available information for 33 items related to structure and methodology in six domains and also for reported outcomes.

CORE-MD is a European Union Horizon 2020 project. It reviews methods for evaluating high-risk medical devices in order to translate expert evidence into advice for EU regulators and to recommend an appropriate balance between innovation, safety , and clinical effectiveness.


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