Key Aspects of New EU Medical Devices Regulation (EU 2017/745).
As the new medical devices Regulation (EU) 2017/745 became fully applicable on May 26th, 2021, medical device manufacturers are legally required to ensure that procedures, systems, documentation related to medical devices are in compliance. The Medical Device Regulation (MDR) retain the existing principles and fundamental components of EU Medical Device Directive (MDD) but with significant improvements in each element. […]
New incoming regulation update: In Vitro Diagnostic Regulation (IVDR) 2022
After a five year-long transition period, the IVDD (In Vitro Diagnostic Directive) will be replaced by the IVDR (In Vitro Diagnostic Regulation) on 26th May 2022 and will apply to all in vitro diagnostic devices marketed in EU Member States. The IVDR has the same basic requirements as the IVDD, but with some important improvements […]
Ask the Expert! A quick chat with Merih DURAMAZ, International Project Manager
Tell us about yourself and your job role at Universal Medica? I am a woman with multiple identities: first and foremost a mother of two toddlers, a life companion, a sister, a daughter, a third culture kid, a pharmacist, a manager of my team, an international project manager in medical information and vigilances and a […]
Webinar – Materiovigilance: Everything you need to know about the new European Regulation on Medical Devices (EU Regulation 2017/745)
Language – French This webinar aims to provide clarification on the new EU Regulation on medical devices (EU Regulation 2017/745) which came into force on 25 May 2021. The new regulation outlines a more robust classification system for medical devices and sets out specific requirements for manufacturers, importers, and distributors of medical devices. This webinar […]
New rules on the temporary use authorisation (Autorisation Temporaire d’Utilisation, ATU) in France explained!
In 1994, the temporary use authorisation program was first implemented in France to allow early access to medicines for patients with serious or rare diseases when no authorised therapeutic treatment was available. Initially the ATU established to ensure patient access to human immunodeficiency viruses (HIV) therapies, and today it has expanded to cover all major […]
A quick chat with Stéphanie Le Guillou, Medical Content Manager.
Stéphanie Le Guillou, PharmD, PhD Medical Content Manager, Cherry for Life sciences, a subsidiary of Universal medica group. How is your job role support Universal Medica Group mission of improving patient safety and wellness? I am managing the editorial line of 3 websites of the group. Santé sur le Net a public health website with […]
Strengths and limitations of remote pharmacovigilance audit
The emergence of COVID-19 and the economic consequences and travel restrictions that this pandemic has caused have led pharmaceutical companies to review their audit methods. Remote pharmacovigilance auditing has been implemented exponentially, but what are its Strengths and limitations? Strengths: Maintain audit planning (internal, contractors) in any circumstances (pandemic or other crisis situations…), more flexibility […]
Webinar – Materiovigilance: Everything you need to know about the new European Regulation on Medical Devices (EU Regulation 2017/745)
Universal Medica have hosted its next live webinar on Friday 23 October 2020 at 2:30pm on the topic of medical device vigilance. Our experts presented the new European regulation on post-marketing surveillance of medical devices and addressed the following points: – How to set up post-market surveillance of medical devices and which data to monitor? […]
Biomedical research reform: the Jardé law
The Jardé law, voted in March 2012, aims at giving a legal and statutory framework to clinical trials which involve people. Universal Medica summarizes for you the main points of the decree number 2017-884 of May 9th, 2017 which modifies certain arrangements. Creation of 3 new categories With the Jardé law, the “Biomedical Research (called […]
What is medical information?
The primary role of medical information is to provide an answer to inquiries made by healthcare professionals and patients. The nature of their questions can be: Medical: Therapeutic Indications, Contraindications, Posology, Interactions with other medicinal products Pharmaceutical: dosage form, pharmacology, storage conditions … Crisis management-related: batch recall, stock shortage, etc. Find out more about the […]
