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 Regulation 2023/607?
- What are the transition timelines?
- How should my company manage the EU MDR transition process?
MDR transition extension
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 Medical Device Regulation (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extend the validity of certificates that were valid on the MDR Date of Application (DoA) (May 26, 2021), have not been withdrawn by the Notified Body (NB), and meet all applicable conditions.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.
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
EU MDD to MDR 2017/745 gap transition strategy
Transitioning to the MDR might seem overwhelming, and many companies don’t know where to start. A recommended first step is to assess your current level of compliance. A thorough gap analysis will generate a task list for updating your procedures and documentation. Emergo by UL can assist with this.
A recommended next step is to examine your current clinical data and Clinical Evaluation Report (CER) to make sure you comply with MEDDEV 2.7/1 rev 4. Notified Bodies already require a higher level of overall quality for clinical evidence and complying with clinical data requirements will be a major hurdle for many companies. Get started as soon as possible to avoid unforeseen challenges.
Emergo can help you get started with selecting a Notified Body and application
With our NB selection and application support service, Emergo 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 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 vast experience with NB processes will prevent you from 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.
Emergo has helped medical device manufacturers comply with European regulations since 1997. We have four offices in Europe and act as the official EC REP for over 1,000 medical device companies, so we are uniquely qualified to help you make a smooth transition to the new Medical Device Regulation.