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Progress in medical technology —European rules needed

Conference in Vienna hosted by the Austrian Presidency debated developments in medical technology

An expert conference in Vienna recently hosted by the Austrian Presidency debated the dramatic progress in the field of medical technology. EU legislation must in particular keep pace with the increasing use in medicine of high-tech human and animal tissue products (tissue engineering).

“As novel products in medicine are increasingly difficult to classify according to conventional legislation, close cooperation by the regulatory authorities responsible for medicinal products, biological products and medical devices will be necessary in future to ensure proper safety of patients and efficiency in the health service”, Health Minister Maria Rauch-Kallat said in the margins of the conference. “All the stakeholders in the health service – patients, medical professionals, researchers, health institutions, governments and industry – must be able to rely on and/or ensure appropriate and adequate safety mechanisms.”

The minister said that two proposals for legislation were therefore in the pipeline during the Austrian Presidency: firstly, the revision of the Medical Devices Directive and, secondly, the proposal for a regulation on advanced therapy medicinal products. At their meeting in Vienna, the experts discussed the European Commission’s proposals for a revision of the Medical Devices Directives. The amendments concerning improved clinical evaluation prior to marketing of the products in particular were unanimously welcomed, as they will make a positive contribution to safety and efficiency in the health service.

The experts from Europe’s competent authorities also adopted a resolution on critical analysis of the planned horizontal regulation of the highly developed medical devices sector, in order to ensure the specialist competence of the European authorities responsible for licensing medical devices in future as well.

The group unanimously agreed that Member States’ cooperation in the field of medical technology needs to be intensified and organised on a more professional basis, particularly the tasks of risk prevention, market surveillance, clinical trials and monitoring of the European licensing authorities. Strategic aims must be jointly pursued, as this is the only way to ensure that the European regulatory landscape can keep pace with the dramatic progress in medicine and medical technology.