Our Priorities Medical Technology Regulations

Notified Bodies

Notified Bodies Picture

Notified Bodies are responsible for assessing and (re-)certifying most MDs and IVDs, allowing products to be placed on the market. Both new regulations introduce new obligations for Notified Bodies and will require the assessment of more products than ever before. For example, 35,000 IVDs will be covered by Notified Bodies for the first time.

A fully-functioning and revamped Notified Body system, with capacity to manage the workload under the current and future regulatory framework, is required early in the transition process. At present, our assessment is that there is insufficient availability and expertise in the Notified Body system.

Notified Bodies (NBs) – A Key Pillar of the Medical Technology Regulatory System

Notified Bodies are responsible for assessing medical devices (MDs) and diagnostics (IVDs). They are an indispensable part of the regulatory system since they grant a CE mark to each device before it can be placed in the EU market.

Notified Bodies are undergoing a significant revamp in order to comply with their greater obligations according to the new Medical Device and In Vitro Diagnostic Regulations.

For all relevant resources please see below.