What is an EU Notified Body for MDR and IVDR compliance?
Most medical device and IVD manufacturers pursuing CE Marking in the European Union will need to obtain a Notified Body (NB). Notified Bodies are independent organizations designated by the European Commission and Competent Authorities to assess medical devices and IVDs for compliance with regulatory requirements to obtain CE Marking. They are responsible for ensuring that medical devices and IVDs are safe, effective, and perform according to their intended purpose.
The Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Regulation (IVDR) 2017/746 ushered in a flood of new regulatory challenges for NBs, as well as manufacturers. The regulations introduced stricter requirements for medical devices and IVDs in the form of more rigorous quality management, technical documentation, and post-market surveillance, expanding the scope and meticulousness of NB audits. They also increased accreditation requirements for NBs with new training and competency requirements. Some medical devices and most IVDs under the regulations’ scope require Notified Body involvement for the first time under the MDR or IVDR, which means more demand for NB services.
The role of a Notified Body in MDR and IVDR conformity assessment
NBs evaluate medical devices to determine compliance with EU regulations. This process may include Technical Documentation review, quality management system audits, and clinical evaluations. If a device meets the conformity assessment requirements (Technical Documentation Assessment (TDA)), the Notified Body issues an EC certificate, which allows the manufacturer to affix the CE Mark to the device’s labeling. The scope of the NB audit depends on your device’s characteristics, the manufacturer’s QMS, and the device risk classification. For instance, if your device is an IVD Class A sterile, one of the lowest risk classifications that require NB involvement, the scope of the NB TDA audit will focus on your device’s conformity with sterility requirements. Depending on your device’s risk classification, your NB may conduct follow-up audits and assessments to ensure your continued compliance to post market surveillance, vigilance, and QMS requirements.
How to select a Notified Body
There are many accredited, reputable NBs designated under the MDR and IVDR, though they are not all suited for your device risk class. When looking for a Notified Body, it is important to confirm they have the requisite experience and designation to certify your device class. If you have a legacy device with transition deadlines, you must also consider the NB’s estimated timelines for TDA and QMS audits. Some large NBs operate in markets beyond the EU, which can be a benefit if you plan to seek market authorization in other countries.
You can only lodge an application with one NB at a time, so it is important to make your NB selection carefully.
