The European Union In Vitro Diagnostic Medical Devices Regulation (IVDR)

As we approach the end of the IVDR transition period, after May 26, 2022, all new in vitro diagnostic devices and Class A non-sterile IVD devices will need to be IVDR compliant in order to be marketed in the European Union.  This means that all manufacturers of CE-marked IVD devices will be affected by the […]

How to qualify for orphan designation in the European Union?

There are more than 7000 rare diseases affecting over 400 million people worldwide and 30 million people in European Union. However, only about 5% of rare diseases currently have approved treatments. As many of these diseases are life-threatening, there is a serious need to develop new drugs for rare diseases. Historically, drug development for rare […]

How to obtain the EMA’s Single Marketing Authorization?

All human medicines derived from biotechnology and other high-tech methods must be evaluated by the European Medicines Agency (EMA) via the centralized procedure called single marketing authorization before they can be marketed and made available to patients in the EU. The evaluation process is carried out by the EMA’s Committee for Medicinal Products for Human Use (CHMP) with […]

Webinar – 7 key points for a successful pharmacovigilance inspection

Language – French  The pharmacovigilance inspection is one of the most important practice in terms of workload (preparation, implementation of action plans, etc.) and/or in terms of image (in the event of an injunction, for example). During a PV inspection, the pharmacovigilance system, and the involvement of all those stakeholders are scrutinized. This webinar aims […]

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 […]

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 […]