Today Asphalion experts Lidia Cánovas, Marta Rayo Lunar, Cindy Mancía and Fran Rodríguez are attending the 10 th Annual Conference on Quality and Regulation for Medical Devices and IVD in Tel Aviv. The event, held yearly, focuses on current issues in a variety of fields from the regulatory world of medical devices and IVD.
This year it is focusing on the latest developments in EU Legislation, the difficulties inherent in the changes that occurred with the introduction of the new regulations, the work processes, and decision-making.
Many interesting topics and learnings have been featured at the different sessions. Lidia Cánovas has given a lecture about “Analysis and forecast of the new EU Medical Device Regulations landscape”, covering topics as MDR timelines, the degree of MDR implementation by EU companies and what to expect from Regulatory agencies, among others.
Also, Marta Rayo Lunar has given a talk about “Combination Products in the EU and the interaction between Directive 2001/83 relating to medicinal products and Regulation 2017/745 concerning medical devices”, giving an overview about conformity assessment procedures, impact of article 117 of MDR in the dossier of the Medicinal product, and management of post-CE marking modification concerning the active substance, etc.
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