Europe Acts to Standardize Clinical Development

The European Forum for GCP (EFGCP) and MedTech Europe have established a Medical Technology Working Party to promote collaboration and dialogue between all stakeholders on the specific aspects of clinical standards.

Setting effective ethical and quality standards for medical technology is critical to ensuring that patients have access to safe and effective treatment, according to a joint statement issued on September 4. The group will strive to make 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, MD, “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 GCP, quality and ethical issues in 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 organize 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 December 4 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.

MedTech Europe comprises the alliance of European medical technology industry associations.

Read the full release here.