NOTICIAS

Principles and Practices for Medical Device Cybersecurity

Principles and Practices for Medical Device Cybersecurity

This document is designed to provide concrete recommendations to all responsible stakeholders  on the general principles and best practices for medical device cybersecurity (including in vitro diagnostic (IVD) medical devices). In general, it outlines recommendations...

Second MDR Corrigendum Targets Class I Devices

Second MDR Corrigendum Targets Class I Devices

The Council of the European Union has published a second set of corrections as part of a corrigendum for the EU’s Medical Devices Regulation (MDR), this time giving manufacturers of certain Class I devices an additional four years to comply.

Nova creditação OF para GMP2020

Nova creditação OF para GMP2020

A 3ª edição da formação sobre as Boas Práticas de Fabrico . GMP 2020, que terá lugar o próximo dia 11 de dezembro de 2019, em Lisboa , no hotel Novotel , tem sido creditada pela Ordem dos Farmacêuticos com 0.7 CDP Esta formação fornece um análise detalhada  das novas...

GUIDELINE ON DATA INTEGRITY

GUIDELINE ON DATA INTEGRITY

© World Health Organization 2019 The World Health Organization (WHO)  elaborou uma nova draft guideline sobre a integridade dos dados,que explica quais os elementos cruciais para garantir a confiabilidade dos dados e as informações na produção e controle de produtos...

Vagas esgotadas para a formação sobre TRAINING COMPLIANCE

Vagas esgotadas para a formação sobre TRAINING COMPLIANCE

No próximo 26 de novembro de 2019 , terá lugar a 1ª edição da formação exclusiva da Formiventos sobre TRAINING COMPLIANCE , conduzida pelo especialista Dr Pedro Vale Gonçalves, bajo o lema "Como desenhar e implementar uma estratégia de formação e manutenção  da...

IMDRF Offers Three Final Clinical Guidelines

IMDRF Offers Three Final Clinical Guidelines

The International Medical Device Regulators Forum (IMDRF) recently released three final documents on clinical evaluations, clinical investigations and clinical evidence for medical devices,    Clinical Evidence - Key Definitions and Concepts - PDF (185kb)...

Publicado “Regulamento de gestão da disponibilidade do medicamento”

Publicado “Regulamento de gestão da disponibilidade do medicamento”

O Regulamento de gestão da disponibilidade do medicamento foi aprovado - através da Deliberação N.º 93/CD/20019 l  Este regulamento tem como objeto a fixação de regras e procedimentos para gerir a disponibilidade do medicamento, designamente no que se refere às...

EMA Updates Q&A on MDR, IVDR

EMA Updates Q&A on MDR, IVDR

The European Medicines Agency (EMA) on Tuesday released an updated and revised questions and answers (Q&A) document on the implementation of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This Question and Answer (Q&A) document...

MDR Guidance Addresses Transitional Provisions

MDR Guidance Addresses Transitional Provisions

The European Commission’s Medical Device Coordination Group (MDCG) on Friday released guidance to further explain Article 120(2) of the EU Medical Devices Regulation (MDR), which says that certificates issued in accordance with the previous device directives will...

EC  MDR Guidance on New Safety and Clinical Performance Summary

EC MDR Guidance on New Safety and Clinical Performance Summary

The main purpose of this document is to provide guidance on the presentation,content and validation of the SSCP. The word “shall” is used when there is a corresponding “shall” in the MDR, otherwise “should” or “recommended” etc. is used indicating the interpretation...

Regulatory Submissions for Medical Devices in Electronic Format

Regulatory Submissions for Medical Devices in Electronic Format

This document provides guidance on FDA’s interpretation of the statutory requirement for  submission in electronic format; however, this document also contains guidance on additional  submission types for which submission in electronic format is anticipated to be...

EMA’s work on new veterinary regulation advances

EMA’s work on new veterinary regulation advances

PUBLISHED BY EMA News 23/09/2019 EMA has launched a new webpage that shows the progress made by the Agency in the implementation of the new Veterinary Medicines Regulation (Regulation (EU) 2019/6), which becomes applicable on 28 January 2022. On this webpage,...

Regulating medical devices in the event of a no-deal Brexit

Regulating medical devices in the event of a no-deal Brexit

This guidance will apply from exit day in line with the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 . This guidance sets out how medical devices will be regulated in the UK in a no-deal Brexit scenario. In a no deal scenario the UK’s current...

PARCERIA ADIFA  e FORMIVENTOS

PARCERIA ADIFA e FORMIVENTOS

A ADIFA , Associação  de Distribuidores Farmacêuticos, respondendo ao  objetivo de contribuir para a melhoria das competências profissionais dos seus associados; tem estabelecida  uma parceria com a Formiventos para oferecer-lhes condições  especiais para o acceso aos...

EudraVigilance Operational Plan: Milestones 2018 to 2020

EudraVigilance Operational Plan: Milestones 2018 to 2020

EudraVigilance is the central pillar for pharmacovigilance activities in the European Economic Area (EEA). In February and April 2017, the new EudraVigilance system successfully passed an independent audit in accordance with Article 24 of Regulation (EC) 726/2004. The...

CDRH regulatory science priorities

CDRH regulatory science priorities

CDRH regulatory science priorities : Leverage “Big Data” for regulatory decision-making . Modernize biocompatibility and biological risk evaluation of device materials Leverage real-world evidence and employ evidence synthesis across multiple domains in regulatory...

EC revised SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE

EC revised SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE

The European Commission  issued a revised questions and answers guideline on implementing safety features for medicinal products detailed in Commission Delegated Regulation (EU) 2016/161.   The revised document includes three new questions and answers as well as one...

Transforming Regulatory Operations

Transforming Regulatory Operations

Posted 17 July 2019 | By Eckart W. Schwarz, MD, Adrian Cottrell, PhD  Regulatory Focus™ This article describes one global pharmaceutical company’s efforts to improve efficiencies, maintain compliance with new standards and gain greater internal alignment. By...

How To Recognize Effective CAPAs And A Culture Of Quality

How To Recognize Effective CAPAs And A Culture Of Quality

Article | MED DEVICE ON LINE    ABOUT THE AUTHOR Leo Gelera, Quality Manager Leo joined FMI in March of 2012. Leo began his career in medical device manufacturing specifically working for Abbott and Baxter Healthcare. He dedicated his time to various quality...

Factsheet for Manufacturers of Medical Devices

Factsheet for Manufacturers of Medical Devices

This Factsheet is aimed at manufacturers of medical devices. For a general overview of the impact of the In-VitroMedical Devices Regulation (IVDR) on manufacturers see the Factsheet for manufacturers of in-vitro diagnostic medical devices. References to Annexes and...