EC publishes proposed amendments to device directives:
This article was originally published in Clinica
Executive Summary
The European Commission published on its website on December 22 its proposed changes to the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC). The proposal - running to 41-pages and including a 21-page impact assessment document was drafted after extensive stakeholder and public consultations. The most significant changes centre on conformity assessment, including design documentation and design review, clarification of the clinical evaluation requirements, post-market surveillance and compliance of custom-made device manufacturers. Commission vice-president Guenter Verheugen says the initiative will simplify and clarify current rules, while continuing to provide patient safety and foster competitiveness. Industry and regulators support the initiative, says the Commission, which is expected to lead to a resurgence of the sector in general. In the context of the amendments, the Biocidal Directive (98/8/EC) will also be changed to exclude IVDs from its scope. Details will be included in the next issue of Clinica. The text can be viewed at: http//europa.eu.int/comm/enterprise/medical_devices/revision_mdd_en.htm