ABSTRACT

"Materials vigilance" protects patients from medical device malfunctions. Traceability tracks device life. Each state's medical device safety is its responsibility. Medical device risk classification. EU medical device markets need CE markings. "Notified body" issues 5-year certifications. Market and incidents are monitored. Rules boost efficiency and transparency. Medical device incident reporting increases safety. Local reporters must report incidents to ANSM. ANSM assesses the safety, efficacy, and quality of healthcare products nationally, centralises vigilance reports, and makes decisions. Medical device law is unified by European and global materials vigilance. Traceability aids medical device recalls. Traceability is the responsibility of each centre, not the manufacturer. CE labels are safe. IUDIs, standardised label data, barcodes, and terminology improve traceability. Create international databases In this article Risk Management Process is explained and used when obtaining preliminary marketing authorization or making major changes to an existing product registration in the EU. In March 2017, the EU accepted a revised version of its Good Pharmacovigilance Practices (GVP) Guideline, Module V Risk Management Systems, which gives a framework for constructing more specified, achievable, and risk-proportionate RMPs. Using Module V of the GVP and its interpretation to analyse RMP risks. Keywords: Good Pharmacovigilance Practice, Risk Management System, Risk Management Product, Modules V, Safety perspective
Publication date: 01/07/2023

https://ijbpas.com/pdf/2023/July/MS_IJBPAS_2023_7316.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.7.7316