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.
Our Priorities Medical Technology Regulations
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.
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.
New IVD symbols for compliance with the IVDR
By 26 May 2022, IVD devices will transition to the new IVD Regulation EU 2017/746. This regulation will require devices intended for self-testing, devices intended for near-patient testing and certain rapid tests (not for self-testing and not for near patient testing) to state these facts on their labels.
Training and Education
The system for ensuring that medical devices meet the necessary standards, specifications, quality, safety and performance requirements is complex. Understanding EU legislation, they key regulatory actors and the essential steps in the CE marking system is vital to bringing products to market.
Our members are currently managing four- and five-year transition periods to the new regulations. This presents considerable uncertainties that need to be reduced through, for example, practical explanations of what companies can and cannot do over the coming years. It is also essential that we flag our concerns about the feasibility of the transition periods to the authorities.