NORE Network of Orthopaedic Registries of Europe

NORE Event on Medical Devices regulations
Engaging with the new EU regulatory landscape for medical devices – Challenges and Opportunities
NIMAC Symposium | Brussels, Belgium | 06 April 2018

NORE, the Network of Orthopaedic Registries of Europe, is an international registry network built up as a standing committee of EFORT and founded in 2015. The network is organised as an EFORT standing committee and reports to the EFORT Board.

NORE focuses on medical device surveillance and arthroplasty outcome in order to support improvements in patient care.

NORE provides advice and awareness to EFORT on international perspective, experiences and practices in medical device surveillance and outcome. This ranges from data capture (e.g. nomenclature on implant attributes) through data analysis and reporting techniques, to new methodology for evaluating performance of medical devices.

As a standing committee, NORE is embedded within EFORT and can use the EFORT platform to disseminate education and research on registry data to the members and the public and government bodies and related industry to create awareness on performance of medical devices. This enhances patients’ and public confidence and trust in both medical devices and surgeons who use them in order to sustain and improve public health. To that purpose, symposia with involvement of all stakeholders are organised.

Although NORE initially focused on registries of hip and knee implants and procedures, other initiatives and established registry formats for other joints (e.g. ankle, shoulder, spine) and diseases (hip fractures, clubfeet etc.) as well as regional and hospital-based registries are part of the NORE network. The purpose with the latter is to present “best practices” from established registries within the network in order to create a blueprint for emerging registries.

The majority of NORE activities are dealt with within Working Groups: the building blocks of the network. The initial NORE Working Groups are:

• Education (supporting EFORT annual congresses).
• Support to emerging registries.
• Stakeholder Registry data reporting.
• Science (i.e. research grants).

Prof. Dr. Rob GHH Nelissen EFORT Board Representative (Secretary General)	Ass. Prof. Maziar Mohaddes   Chairman EFORT NORE

NORE is organised as an EFORT standing committee and reports to the EFORT Board.

The governance structure was defined at the NORE kick-off meeting during the EFORT Congress 2015 held in Prague (Czech Republic).

The following structure of NORE, and in particular the Advisory Board has been discussed at the EFORT Congress 2016 in Geneva (Switzerland):

• a Chairman and a member of the EFORT Board,
• and in addition, members from the NORE network representing the British Orthopaedic Association (BOA) or the National Joint Registry (NJR), the Nordic Arthroplasty Register Association (NARA), the German Hip Arthroplasty Register (EPRD), other European Registries and the International Society of Arthroplasty Registries (ISAR).

The NORE Advisory Board members are:

• Prof. Rob NELISSEN | NORE Chairman
• Prof. Klaus-Peter GÜNTHER | EFORT Board Representative
• Prof. Per KJAERSGAARD-ANDERSEN | Nordic Countries Representative
• Prof. Carsten PERKA | German Representative
• Dr. Amie SMIRTHWAITE | Notified Body BSI
• Dr. Marine TORRE | Health Authorities Italy
• Keith TUCKER | NJR / ODEP

Charter of NORE – Network of Orthopaedic Registries of Europe
As of 2 June 2015

1. MISSION

NORE as an all-inclusive network will foster 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.

NORE will provide advice and awareness to EFORT on international perspectives, experiences and practices in medical device surveillance. This may range from data capture (e.g. nomenclature) through data analysis and reporting techniques, to new methods for evaluating performance of medical devices.

2. RESPONSIBILITIES OF NORE

1. Create an all-inclusive national, regional and speciality society orthopaedic registry network.
2. Advice to emerging but also to established registries on registry related issues (e.g. data collection, methodological issues etc).
3. Initiate education and research projects within the network.
4. Promote awareness of NORE and its activities on an international level.
5. Comply with responsibilities of an EFORT standing committee.
6. Stimulate uniformity of registration and definition to enhance comparison of findings within Europe.

3. ORGANISATIONAL STRUCTURE

NORE stands for Network of Orthopaedic Registries of Europe. Initially, NORE will focus on Registries of Hip and Knee Arthroplasty – although initiatives and established registry formats for other joints and diseases (e.g. ankle, shoulder, spine, hip fractures) are not excluded. Even more, these established formats may help to create a blueprint to be used by others. The goal of the organisation is to produce uniformity in nomenclature and define those variables to be collected within a registry as a dataset.

The network is organised as a standing EFORT committee and reports to the EFORT Board.

As such, the EFORT regulations for standing committees apply except that it is anticipated that the organisational structure will be self-funding.

The network will be led by an Advisory Board under the leadership of a chairman appointed by EFORT for three years. The chairman can be re-elected once. The current chairman is Prof. Dr. Rob G.H.H. Nelissen, Chair & Professor Orthopaedics at Leiden University Medical Center (the Netherlands).

The Chairman will be a member of the EFORT Executive Committee with the following responsibilities:

• Participation in the two annual Executive Committee meetings (Jan/Feb and June, during the EFORT congress)
• Report to the EFORT Board & the EFORT Executive Committee on request, and in an annual written report
• Set-up an annual budget proposal to be delivered to the EFORT Board for their meeting in September
• Leading/chairing of the committee

A possible structure of NORE could be that members of the Advisory Board are constituted by at least:

• a Chairman and a member of the EFORT board,
• and in addition, members from the NORE network representing the British Orthopaedic Association (BOA) or the National Joint Registry (NJR), the Nordic Arthroplasty Register Association (NARA), the German Hip Arthroplasty Register (EPRD), other European Registry and the International Society of Arthroplasty Registries (ISAR).

4. ACTIVITIES

The majority of NORE activities will occur in working groups. In general, each working group shall have at least one NORE Advisory Board member, who is responsible for progress on the assigned working group topic. Challenges for the use of registry data ranging from research to education purposes are evident and can be addressed in working groups. These will report back to the annual meeting of NORE planned alongside the EFORT annual congress. A working group structure could be:

1) PROM definitions
2) Outcome research
3) Implant library
4) International relationship
5) Working with authorities
6) Methodology and standardisations outcome research
7) Symposium/scientific organisation for EFORT congresses
8) Advice start-up registries

5. COLLABORATION

Collaboration with other international organisations (e.g. ISAR, ICOR etc) on registry data will improve implant related patient outcome. The main difference with other organisations is that NORE uses the EFORT forum as platform for its education and research endeavours.