Medical devices : the enhanced surveillance

stokkete/epictura

Published the 29.08.2017 at 18: 10

A A

Keywords :

device médicalsécurité sanitaireANSM

End of recess for manufacturers of medical devices (DP). Often criticized for its laxity, the legislation on the DP comes to be considerably strengthened on a european level. “These changes, which are necessary for the safety and confidence of health care professionals and patients towards the DM, will be implemented gradually,” to know the national security agency of the drug (MSNA) in a press release published this Tuesday.

Two new, separate regulations have been adopted, one for medical devices (DM), the other for medical devices of in vitro diagnostic (ivd directive). They will respectively be applicable to the next three to five years.

This change in the legislation is very much expected occurs in a market that is considered minimally regulated, and this has given rise to several scandals health – breast implants PIP, injections anti-wrinkle, Essure… ” This review is aimed a strengthening the safety and a harmonisation of the rules applicable to the DM within the european Union. It should also lead to a simplification and improvement of their legibility, and should allow to better adapt to the innovation.”

Strengthened controls

The new regulations also aim to enhance transparency, facilitate the establishment of a european governance of the medical devices sector, as well as a better evaluation pre-and post-placing on the market “, the agency says.

New obligations will be imposed on the operators of the medical devices sector. Thus, among the manufacturers and agents, a person will be responsible for regulatory compliance. By the way, “bonds of caution” will be required for all importers and distributors.

“The competent authorities must develop inspection capabilities for operators in the sector,” says the MAN. The specification is to be strengthened in terms of competence and control (including unannounced visits to manufacturers).

Notification of incidents

Moreover, Europe will acquire a new european database “for a better knowledge of the market, incidents and clinical investigations” throughout the continent. Each DM will have a unique identifier in order to improve the traceability in the chain of distribution.

The incidents related to the RFP must be notified to the european level and manufacturers will have an obligation to produce periodic summaries of safety “. “A proper regulation of the sector at the european level will be implemented using a Coordination Group of national authorities in the field of Medical Devices (MDCG) which tasks will be to ensure the coordination of actions of market surveillance “, it read.