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The relevant legislation on medical devices, active implantable medical devices and in vitro diagnostic medical devices stipulates that all manufacturers, or their authorized representatives who wish to market their medical devices in the European Economic Area, must fulfil certain obligations in relation to vigilance. These obligations are set out in art. 10 of Dir 93/42/EEC of the Ministerial Decree, in art. 8 of Dir 90/385/EEC on DMIA and art. 11 of Dir 98/79/EC on the IVD, and are clarified in the guideline MEDDEV 2.12 / 1, now in its eighth revision, which also provides templates that can be used for reporting to the Competent Authorities. Di Renzo Regulatory Affairs is able to assist its clients with various services in the field of medical devices vigilance: First among these is to take on the role of Head of Vigilance in Italy or in Europe, with the mandate of the manufacturer, or even the role of local contact point, in cases where a manufacturer wishes to maintain the management of vigilance activities. In addition we can deal with the compilation and transmission of notifications of incidents, corrective actions and safety alerts to the Competent Authorities and provide further clarification on the request of the Competent Authorities. We can also assist manufacturers or their authorized representatives during the investigation of an incident, for example by contacting the reporter for more information, or conducting specific literature or safety information research from dedicated databases. We provide continuous updates on the development of national and European legislation to our clients and we can, upon request, provide training sessions for company personnel. We also work with manufacturers to implement, upgrade and manage the system of vigilance and post-marketing surveillance through the preparation of specific Standard Operating Procedures, the gathering of information back from the market, clinical data and the continuous updating of the clinical assessment plan and the risk management plan of various products.
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EU Dir 93/42/EEC as amended on Medical DevicesEU Dir 90/385 as amended on Active Implantable Medical DevicesEU Dir 98/79 as amended on In Vitro Diagnostic Medical DevicesMEDDEV 2.12-1 rev.8
Reference legislationReference legislation
Manufacturers must have in place a dedicated system for the management of vigilance activities.Although it is not yet mandatory, it is strongly recommended in Italy, as in other EU Member States, to appoint a person who is in charge of vigilance procedures, and whose name can be provided to Competent Authorities to be contacted if needed for vigilance issues.
Manufacturer’s obligationsManufacturer’s obligations
The manufacturer or its authorized representative shall notify the Competent Authority if they become aware of any deterioration in the characteristics and performance of a device or any inadequacy in the instructions for use which might lead to or which has caused the death or serious deterioration in the state of health of a patient or user, as well as the safety reasons that led to the withdrawal from the market of a medical device by the manufacturer.
Final report
FSCA & FSNNo action taken –
Justification
Investigation on the event
Incident report
Request of Manufacturer report
Distributor
Healthcare professional
C.A.
Manufacturer
Initial report
Incident report
Lay user
Incident report
Incident reporting systemIncident reporting system
We are able to offer our clients the following services:
Taking on the role of Responsible Person for MD vigilance in Europe, and contact point with the Competent Authorities of various EU Member States (we have partners experienced in regulatory affairs all over the EU)Management of reporting of incidents occurred on the EU and extra-EU territory (Filling in and submission of incident report forms)Assistance to Manufacturers/EU Representatives during the follow-up of incidents (investigation phase)Update on national and European legislationTraining courses for CompaniesDrafting of Company SOPs on MD vigilance & PMS activities
Our servicesOur services
Di Renzo Regulatory AffairsDi Renzo Regulatory Affairs
www.direnzo.biz
Viale Manzoni 5900185 - RomaTel.: +39 06 77209020Fax: +39 06 70474067
P.za Luigi di Savoia 2420124 - MilanoTel.: +39 02 67380552Fax: +39 02 67380552
