Specific legislation
Law no. 95/2006, republished, as subsequently amended
– Title XX – Medical Devices / Chapter 4, Sanctions – Article 934 ÷ 936
News / Alerts
To the attention of interested persons
DECISION NO.44377E / 05.05.2015
download document …
To the attention of interested persons
The National Agency for Medicines and Medical Devices (NAMMD) hereby expresses its concern to ensure public access at all times to medical devices whose design and manufacture preclude harm to patient or other persons’ clinical condition or safety, if used in accordance with their intended purpose and indicated conditions. The aim is that any risks potentially associated with their use should be kept at an acceptable level as compared to the benefits for the patient and compatibility with high protection for user health and safety.
Reports, even if mostly verbal, have lately been received from patients/users of certain medical devices not providing the promised therapeutic effect. Therefore, the NAMMD hereby calls on all interested parties: healthcare professionals, patients, the general public and the media to inform the competent authority on marketing of non-compliant medical devices lacking the CE marking or whose operation may endanger user’s life and health. The NAMMD will strengthen market surveillance and controls in terms of both manufacturers, particularly importers, and wholesalers and retailers of medical devices, to allow creation, by joint effort and cooperation with other institutions with legal competencies in the field, of an environment favouring protection of citizens’ life and health.
REPORT OF COMPLAINTS ON MEDICAL DEVICES QUALITY
Send e-mail report – click here (mdevice@anm.ro)