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Registries and the new EU Medical Device Regulation: Impact on Patient Care, Product Development, Financial Support and Research

Published in N°001 - May / June 2019
Article viewed 110 times

Registries and the new EU Medical Device Regulation: Impact on Patient Care, Product Development, Financial Support and Research

By Gerold Labek in category OPINION
President European Arthroplasty Register Network (EARN) - [email protected]

Medical Devices are a highly regulated business. Manufacturers are in charge by law to provide devices to users and patients, which are safe and perform as intended. They have to provide evidence on that to regulatory bodies. Notified Bodies are the main operative regulatory institutions.

Introduction

Medical Devices are a highly regulated business. Manufacturers are in charge by law to provide devices to users and patients, which are safe and perform as intended (1). They have to provide evidence on that to regulatory bodies. Notified Bodies are the main operative regulatory institutions. They grant the CE-certificates, which allow market access for medical devices in the entire common EU market. They act under supervision of competent authorities by all EU member states and the EU Commission.

To identify potential problems with devices a wide range of instruments has to be implemented according to the present legal frame work, the Medical Device Directive MDD (1). Implants have to be tested extensively during design and development, after marketing potential incidents have to be reported and analysed, risk management have to be implemented for any devices over the entire life time and studies have to be conducted to collect clinical data on the device during patient treatment. These studies are at present a major source for grants supporting research activities.

Nevertheless, the history of arthroplasty shows a series of incidents as almost any other type of medical devices. ASR hip and similar large diameter metal on metal heads or 3M Capital Hip are 2...

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