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The implementation of the European regulation on medical devices

The implementation of the European regulation on medical devices has taken a major step forward with the adoption of a proposal by the European Commission to adapt its transitional provisions. The amendment to the Medical Device Regulation modifies Article 120 to maintain the validity of certificates issued under the directives and allow marketing of corresponding […]

Forthcoming changes to accessing and managing EudraVigilance

The EudraVigilance system will undergo several updates over the next few months to improve its security and user management processes. These updates include: Multi-factor authentication (MFA): The European Medicines Agency (EMA) has already implemented MFA for some of its systems and plans to enable it for access to EudraVigilance in March 2023, followed by EVDAS […]

The MDCG clarifies important vigilance terms and concepts in the new MDR

The Medical Device Coordination Group (MDCG) has clarified important vigilance terms and concepts used in the MDR in order to provide a common understanding of these terms and concepts necessary for an effective and harmonised implementation of vigilance requirements. Some of the definitions have been reintroduced from the Medical Devices Vigilance Guidance, modified where necessary […]

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 […]

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 […]