Notified Body Support for Medical Device Compliance

Overview of notified bodies for medical devices

For companies marketing their devices in the European Union, maintaining CE marking means MDR compliance regardless of challenges such as Notified Body staff shortages and work backlogs. 

ANSWERED ON THIS PAGE: 

• What is a notified body for medical devices?
• Which notified bodies have MDR designation?
• Why do you need a notified body for medical device CE marking?
• How does Regulation 2023/607 affect medical device manufacturers and notified bodies during the CE marking process?
• How does the MDD to MDR transition timelines affect a notified body's CE marking process?

MDR transition timelines affecting notified bodies

Medical device manufacturers seeking to obtain or maintain CE marking for their products to be sold in Europe must undergo audits from notified bodies (NB) designated under the Medical Devices Regulation (MDR). But finding an NB for CE marking and MDR compliance can be less than straightforward. 

Regulation 2023/607 extends the period during which manufacturers may continue to leverage valid Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD) CE marking certificates for legacy medical devices to Dec. 31, 2027, or Dec. 31, 2028, depending on the device classification. In addition, Article 120(2) of the MDR is amended to extend the validity of certificates that were valid on the MDR Date of Application (DoA) (May 26, 2021), have not been withdrawn by the NB, and meet all applicable conditions.  

The amendment only applies to legacy devices, i.e., devices that were placed on the market before the MDR DoA and fulfill all additional conditions defined in the Regulation. New devices and legacy devices that have a significant change in design or intended purpose still need to be compliant with the MDR when they are placed on the EU market. Note that one of the new conditions is Article 120 (3c)(e), which states that before May 26, 2024, the manufacturer must lodge a formal application with an NB for CE marking under the MDR.  

Notably, for certificates that had already expired prior to March 20, 2023, there are more stringent criteria, e.g., at the moment of expiry, the manufacturer had already signed a contract with an NB for CE marking under the MDR. 

EU device regulation timelines for Notified Bodies and manufacturers

The new transition dates for MDR CE marking are as follows: 

• Dec. 31, 2027 – Class III and most Class IIb implantable devices 
• Dec. 31, 2028 – All other Class IIb devices, all Class IIa devices, Class I sterile or measuring devices, and formerly self-certified MDD Class I devices that require NB intervention under the MDR 
• May 26, 2026: Class III custom-made implantable devices  

Notified Body support services for medical device manufacturers

With our NB selection and application support service, Emergo by UL will take the lead to assist with the selection of an NB and submission of the application to obtain a formal contract for your certification audit and therefore remain eligible for an extension of your legacy device certificate according to Regulation 2023/607. 

The service starts with verifying the classification of the device, including a review of the applied classification rationale to determine compliance with the MDR or In Vitro Diagnostic Medical Devices Regulation (IVDR), and a high-level review of the technical documentation (e.g., risk management, clinical evaluation reports, labeling, IFUs). Emergo will then identify NBs based on product type, accredited scope and experience to approach for an MDR/IVDR audit application and prepare and submit the MDR/IVDR audit application to the identified NBs. 

Emergo’s experience with NB processes will help you avoid common pitfalls and make NB discussions more efficient. By outsourcing the NB application activities, your organization can focus on business operations, while Emergo interacts with the various NBs on your behalf. 

In addition, Emergo can provide strategic consulting in case there are questions about the application process and/or assistance with the Technical Documentation File (TDF), including a review if requested. 

Helping companies with EU NB audits since 1997

Emergo has helped medical device manufacturers comply with European regulations since 1997. We have four offices in Europe and act as the official European Authorized Representative (EC REP) for over 1,000 medical device companies, so we are uniquely qualified to help you make a smooth transition to the MDR and IVDR.