European Federation of National Associations of Orthopaedics and Traumatology

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Jan 2017 - Dec 2017

75,000€

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none

-Observers in the new subgroups of the Medical Device Coordination Group (MDCG)
-Invitation for EFORT to speak at the EU parliament (4 April) on "The importance of registers to determine the quality of implants and to stop usage of failing devices"
-SCENIHR

The healthcare debate is put at the forefront. As Mr. President Jean-Claude Juncker declared on the occasion of the 10th World Health Summit held in Berlin in 2019 "Our joint resolve to protect the health and wellbeing of all of our citizens now and in the future is stronger than ever.”
Trying to match EFORT’s initiatives with the 10 political priorities of the Juncker Commission in order to influence the European Health agenda in the field of musculoskeletal health would probably focus on the following aspects:
- Job, Growth and investment
- A deeper and fairer internal market with a strengthened industrial base
- A balanced and progressive trade policy to harness globalisation

EFORT has been active within the European Reference Network with a specific objective to make Health care systems effective, accessible and resilient (1.4 of the Management Plan 2018 for DG Health and Food Safety – SANTE). Similarly for increased access to medical expertise and information for specific conditions (1.5 of the Management Plan 2018 for DG Health and Food Safety – SANTE)

As another activity NORE is an all-inclusive network that fosters international collaboration and co-ordination of learning and research in orthopaedics, with special focus on medical device surveillance, arthroplasty outcome, and other registries of orthopaedic conditions in order to support improvements in patient care. The specific objective 1.6: Effective, efficient and reliable official controls (Management Plan 2018 for DG Health and Food Safety – SANTE) proposes “to carry out approximately 40 joint assessments of notified bodies designated under the medical devices and in vitro diagnostic medical devices Regulations”. This ties into registry activities and is likely to firm EFORT’s position expressed in recently published statements:
-New Medical Devices Regulations (MDR) and In Vitro Diagnostic Medical Devices Regulations (IVDR) - https://www.efort.org/mdr/

-Are Orthopaedic and Trauma implants safe? - https://www.efort.org/efort-are-orthopaedic-and-trauma-implants-safe/

Another good example is the specific objective 2.1: Effective EU assessment of medicinal products and other treatment (Management Plan 2018 for DG Health and Food Safety – SANTE). Through the EFORT affiliation to Biomed Alliance demonstrates our belief that a collaborative framework for the clinical assessment of health technologies is necessary to support high-quality healthcare in Europe.
-European Doctors unite to demand policymakers support for EU-Level HTA - https://www.efort.org/jt-hta/

Further EFORT was represented in the recently held JRC Ispra meeting on medical devices of 11 February aiming at the finalisation of the landscape of the expert panels and the finalisation of the list of medical specialties and subspecialties that should be used for the call for experts.

No later than today EFORT has also been confirmed as observer in the subgroup Clinical Investigation and Evaluation (CIE) of the Medical Devices Coordination Group (MDCG).

Earlier and through input and participation in SCENIHR Metal on Metal controversies were discussed.

-European Commission issued Final Opinion on the Safety of Metal-on-Metal (MoM) Joint Replacements with a particular focus on hip implants – https://www.efort.org/eu_commission_mom/

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None declared