New multi-stakeholder collaboration will drive dialogue on specificities of clinical standards for medical technology
Brussels, 4 September 2014 – The European Forum for Good Clinical Practice (EFGCP) and MedTech Europe, the alliance of European medical technology industry associations, today announce the establishment of a joint Medical Technology Working Party within EFGCP aimed at addressing ethical and quality issues when setting standards for clinical evaluation in the medical technology sector.
Setting effective ethical and quality clinical standards for medical technology is critical to ensuring that patients have access to safe and effective treatment. The joint EFGCP-MedTech Europe “Medical Technology Working Party” will seek to involve stakeholders in a dialogue on making sure these standards are broadly accepted and reliably introduced in the rapidly developing, diverse medical technology landscape.
“Historically, the clinical development debate has focused on pharmaceuticals,” said EFGCP Chair Ingrid Klingmann, “but it’s important that we have a deeper conversation about issues that need to be considered when setting standards for the medical technology sector.”
The working party hopes to attract a broad group of expert stakeholders including patient advocates, physician groups, academics, ethics committees, competent authorities and medtech and pharma industry representatives to collect views on good clinical practice, quality and ethical issues as they pertain to medical technology and provide recommendations to policy-makers. MedTech Europe CEO Serge Bernasconi said: “There’s a growing understanding in the healthcare policy arena that we can’t just copy and paste the pharmaceutical approach to clinical standards into EU legislation on medical devices and in vitro diagnostics. Only with a vibrant dialogue can we figure out which direction is right for medical technology and above all, for the patient.”
The working group will initially organise a joint workshop on Mitigating Risks in the Lifecycle of Medical Devices: Options and Challenges in the Medical Device Legislation. The workshop, to be held on 4 December in Brussels, will bring together patients, national competent authorities, ethics committees, lab technicians, healthcare professionals, industry representatives and European regulatory authorities with the aim of finding consensus on key topics of interest and potential policy recommendations.
There will be a separate discussion specifically on in vitro diagnostics and particular considerations related to the proposed IVD Regulation, with the view to organising a high-level, multi-stakeholder roundtable and assess the key concerns.
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About the European Forum for Good Clinical Practice
The European Forum for Good Clinical Practice (EFGCP) is a non-profit organisation established by and for individuals with a professional involvement in the conduct of biomedical research. Its purpose is to promote Good Clinical Practice (GCP) and encourage the practice of common, high-quality standards in all stages of biomedical research throughout Europe and globally. The EFGCP does this by promoting contact and partnership between the major disciplines and organisations affected by good clinical practice: pharmaceutical companies; contract research organisations; suppliers of services, systems and equipment; academia; investigators; ethics committees; regulatory authorities; patient organisations; etc. For more information, visit www.efgcp.eu.
Ingrid Klingmann, MD, PhD
Chairman of the Board, EFCGP
T: +32 (0)2 784 36 93
M: +32 (0)475 29 59 18
Ingmar de Gooijer
Director Communications, MedTech Europe
T: +32 (0)2 775 92 24
M: +32 (0)492 97 14 70