Your Definitive Guide to CE Marking
New IVDR Notified Body in Slovakia: 3EC International has been approved to undertake IVDR conformity assessments.
The Irish NSAI expects approval to get the EU MedTech
The French Notified Body ANSM (The National Security Agency of Medicines and Health Products) recommended breast implants produced by Cereplas to be recalled from the European market.
The compliance assessment procedure of certain products with the Europeans standards, as laid down in their corresponding EU directive, may involve the notification of third-party, independent bodies. In the EU, such organisations are called Notified Bodies and their role is to evaluate whether the product complies with the relevant legislation in force.1) In this article I will discuss what the role and responsibilities of a Notified Bodies are.