Hepatitis E Virus RNA Screening
Hepatitis E virus (HEV)
Parvovirus B19 DNA Quantification, Hepatitis A Virus RNA Detection
Parvovirus B19 genotypes 1, 2, and 3 DNA | Hepatitis A virus (HAV) genotypes I, II, and III RNA
Implantable stimulation device for neurological applications
Neurology
Harmonised Standards for MDR
With the new regulation for medical devices (MDR (EU) 2017/745) new standards need to be harmonized by the European Commission. In this post we inform about the most important questions and provide a list of current harmonised standards, published in the Official Journal of the European Union. Current list of harmonised standards for MDR (updated […]
Interactive IVDR
IVDR with Links The IVDR is a complex document. We created a version with links for a better reading-experience. We will keep it up-to-date with upcoming amendments. But we cannot guarantee a complete or correct text. Note, that it is not the legally binding version of the IVDR (EU) 2017/746. You will find the complete […]
Learning from the Team-NB survey 2021
Learning from the team-NB survey 2021 The Team-NB Survey 2021 Team-NB, The European Association for Medical devices of Notified Bodies, has published the press release of its sector survey 2021 with shocking but not surprising news: “The number of certificates that could be issued has been estimated to 6.300 certificates per year (on the basis […]
List of views provided under the PECP
Rule 5: IVD or not IVD?
Rule 5: IVD or not IVD? A complex question reaches us often: the question about products for general laboratory use. Manufacturers of laboratory equipment for the examination of human samples often want to market them under IVDR but often don’t fulfil the two most essential requirements: Firstly, the product must meet the requirements to be […]
List of views provided under the CECP
List of views provided under the CECP This page lists all published expert decisions and opinions in the context of the Clinical Evaluation Consultation Procedure (CECP) according to Article 54 of Regulation (EU) 2017/745). The consultation procedure might be relevant to you, if you are a manufacturer of one of the following devices (exceptions, see Article 54 […]
Interactive MDR
MDR with links The MDR is a complex document. We created a version with links for a better reading-experience. We will keep it up-to-date with upcoming amendments. But we cannot guarantee a complete or correct text. Note, that it is not the legally binding version of the MDR (EU) 2017/745. You will find the complete […]
Native Tricuspid Valve Replacement
Circulatory system
Transcatheter Heart Valves and Delivery System
Circulatory system