European Federation of National Associations of Orthopaedics and Traumatology

EFORT is member of:
Biomed Alliance www.biomedeurope.org
AC Forum: www.acforum.net
Health First Europe www.healthfirsteurope.eu

None declared

Jan 2019 - Dec 2019

75,000€

None declared

Medical Device Coordination Group#X03565#http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=3565 #Observer #C#Professionals#03 - Clinical Investigation and Evaluation (CIE)

-Observers in the new subgroups of the Medical Device Coordination Group (MDCG) and now also invited to participate in the meeting between MDCG and stakeholders
-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
--Expert panels: EFORT chairs the Thematic panel for Orthopaedics, Traumatology, Rehabilitation,
Rheumatology and has a representative in the Screening Panel

Trying to match EFORT’s initiatives notably based on 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.

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/

EFORT also organized an inaugural workshop "EFORT Implant & Patient Safety Initiative" which took place at the State Chancellery of Saxony at the Saxony Liaison Office in Brussels. This meeting gathered participants representing surgeons in orthopaedics and traumatology, manufacturers, notified bodies and representatives of the European Commission.

EFORT also endorses the OECD PaRIS Hip and Knee Data Collection Guidelines along with ISOC, ISAR, NJR and World Confederation for Physical Therapy

None declared