EU has 18 notified bodies for IVDs (in vitro diagnostics):
This article was originally published in Clinica
Executive Summary
There are now a total of 18 notified bodies authorised to test products against the requirements of the EU's IVD Directive in eight of the 15 member states of the European Economic Area, where the IVD Directive applies. Some are only authorised to test a small range of IVDs, while others offer the full range of testing under the IVD Directive. The notified bodies are based in: Germany (7), the UK (3), the Netherlands (2), Denmark (2), Austria (1), France (1), Finland (1) and Portugal (1). A full listing is available on the European Commission's website. There are 17 notified bodies in the EEA member states that can test against the requirements of the Active Implantable Medical Devices Directive, and a further two non-EEA member states. There are 57 EEA bodies that can test against the requirements of the Medical Devices Directive, and a further eight in non-EEA member states.