The Commission proposes improvements to the current law on medical devices to address the existing shortcomings: stronger supervision of notified bodies to ensure conformity of assessment; stricter controls on manufacturers through unannounced inspections; better public information through an extended database on medical devices; and the introduction of a unique identifier to improve traceability and recalls in case of safety concerns.
While the rapporteur acknowledges the Commission's efforts, too much emphasis is put on placing medical devices on the market as quickly as possible – to the detriment of patient safety. Dagmar Roth-Behrendt's report aims at strengthening the patient safety aspects of the legislation, including creating a centralised pre-marketing authorisation procedure for high-risk devices involving a public health agency at EU level (EMA); reinforced qualification requirements for the staff of notified bodies and availability of in-house expertise; and stricter provisions on multiple-use devices, including EU-wide standards for reprocessing.