NOTICIAS

THE FUTURE OF EUROPE’S MEDICAL TECHNOLOGY REGULATIONS

THE FUTURE OF EUROPE’S MEDICAL TECHNOLOGY REGULATIONS

MedTech Europe and its members fully support the objectives of the medical technology regulations IVDR and MDR to establish a “robust, transparent, predictable and sustainable regulatory framework for [in vitro diagnostic] medical devices which ensures a high level of...

Personalized Medical Devices – Regulatory Pathways

Personalized Medical Devices – Regulatory Pathways

The primary purpose of this IMDRF guidance is to recommend a harmonized approach for the application of existing regulatory pathways to medical devices that are intended for a particular individual, and to identify special considerations for the regulation of each...

CREDITAÇÃO DA OF PARA A FORMAÇÃO “PREÇOS de MEDICAMENTOS “

CREDITAÇÃO DA OF PARA A FORMAÇÃO “PREÇOS de MEDICAMENTOS “

Apresentamos-lhe a edição número 2 da formação sobre "Aprovação, Formação e Revisão anual de PREÇOS de MEDICAMENTOS" que vai decorrer no próximo dia 21 de novembro em Lisboa . Um guia completo para o desenvolvimento da estratégia de pedido de preço de medicamentos, e...

EU MDR/IVDR (Notified Bodies Survey (October 2023))

EU MDR/IVDR (Notified Bodies Survey (October 2023))

  The EU Commission has today published 'Notified Bodies Survey on certifications and applications (MDR/IVDR) Survey results with data status 30 June 2023 (medium and small dataset)' The aim of the study is to support monitoring and analyzing the availability of...

EUDAMED RoadMap

EUDAMED RoadMap

The EU Commission has today published a Draft EUDAMED RoadMap with updated timelines for each module and mandatory use dates. Q4 2027: Actor, Certificates, MSU, Vigilance and CI/PS (MDR Article 123(3) (d) ) / (IVDR Article 113(3) (f)) Q2 2029: Devices and Certificates...

Regulatory considerations on artificial intelligence for health

Regulatory considerations on artificial intelligence for health

The World Health Organization (WHO) has released a new publication listing key regulatory considerations on artificial intelligence (AI) for health. The publication emphasizes the importance of establishing AI systems’ safety and effectiveness, rapidly making...

The European Medical Technology in Figures 2023

The European Medical Technology in Figures 2023

MedTech Europe has developed this interactive Data Hub to provide the most relevant and up-to-date insights regarding the state of the medical technology industry. Capturing the activity of the medical technology industry is vital for healthcare stakeholders, business...

Revised CTIS Transparency Rules

Revised CTIS Transparency Rules

Since the launch of CTIS in 2022, the deferral functionalities have proven to be complex from an information management and data security perspective, which has led to some uncertainties in the use of CTIS when deferrals were applied. The deferral functionality,...

EMA Questions and answers for biological medicinal products

EMA Questions and answers for biological medicinal products

  Table of contents Reprocessing (3.2.S.2.2, 3.2.P.3.3) Raw materials and media components (3.2.S.2.3) Method identification numbers (3.2.S.4.1, 3.2.P.5.1) Process validation, removal of process related impurities, process related impurities testing (3.2.S.2.5,...

Electronic Submission Template for Medical Device 510(k) Submissions

Electronic Submission Template for Medical Device 510(k) Submissions

This guidance provides the standards for the submission of premarket notification (510(k)) submissions by electronic format, a timetable for establishment of these standards, and criteria for waivers of and exemptions from the requirements to meet a statutory...

European Commission Newsletter on medical devices | September 2023

European Commission Newsletter on medical devices | September 2023

This newsletter from the European Commission aims to provide highlights and updates from the medical devices (MDs) and in vitro diagnostic medical devices (IVDMDs) sector. In this edition, you will find updates on the September’s session of the International Medical...

INFARMED Esclarecimentos: Medicamentos essenciais de natureza crítica

INFARMED Esclarecimentos: Medicamentos essenciais de natureza crítica

O presente documento visa clarificar algumas questões relacionadas com a redação da Portaria n.º 235/2023, de 27 de julho, a qual determina a possibilidade de aplicação de medidas específicas que visam garantir o acesso e a manutenção no mercado nacional de...

Labeling for Biosimilar and Interchangeable Biosimilar Products

Labeling for Biosimilar and Interchangeable Biosimilar Products

This guidance is intended to help applicants develop draft labeling for proposed biosimilar and interchangeable biosimilar products2 18 for submission in an application under section 351(k) of the  Public Health Service Act (PHS Act) (42 U.S.C. 262(k)) (351(k)...

Post-Warning Letter Meetings Under GDUFA Guidance for Industry

Post-Warning Letter Meetings Under GDUFA Guidance for Industry

  This guidance provides information on the implementation of the PostWarningLetterMeeting process for certain facilities, a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to the reauthorization of the...

EDQM TRAINING MODULE 7  Control of impurities: CEP approach

EDQM TRAINING MODULE 7 Control of impurities: CEP approach

This module addresses in detail how to  hashtag#controlimpurities  in  hashtag#activesubstances  in the context of a  hashtag#CEPapplication . The presentation outlines how to build and justify an appropriate control strategy, not only for  hashtag#organic  and...