blog
New regulations for IVD Manufacturers when developing new devices
New requirements of the European regulations: demonstration of clinical evidence To improve the health and safety of patients and users,…
publication
Addressing The Impact of The EU Medical Devices Regulation on Combination Products
An inter-regulatory and stakeholder workshop on combination products, organised by TOPRA and RAPS, was held in Brussels in November 2018.…
publication
The Proposed EU IVD Regulation and its Impact on Companion Diagnostic Development
Stricter rules are in store for CDx stakeholders in the EU but it’s not all bad news. Sylvie Le Glédic,…
publication
Biomarkers qualifications: a first step towards companion diagnostic development
Biomarker qualification can be a first step towards companion diagnostic development. The European Medicines Agency already has a biomarker qualification…
publication
Pathways and Strategies for Combination Products in the EU
Determining the regulatory path for a combination product is a difficult task. Even in the USA, which seems to have…
presentation
Understanding the Implications of the New IVDR for Companion Diagnostics (CDx)
IVD Regulation is evolving, with direct impacts on CDx development. The purpose of this presentation will be to explore special…
presentation
Impact of the New Medical Device Regulation on Clinical Evaluations and Investigations
Developing and marketing a medical device in Europe has to follow the European law covered today by the Medical Device…
