Conditional Certificates under the MDR/IVDR: Team-NB Statement on the Application of Specific Rules
Team-NB, the European association of Notified Bodies for medical devices, has published a statement on the possibility of issuing certificates with conditions, provisions or limitations, as provided for in the European Medical Devices Regulation (MDR) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746. This approach allows for a balance between innovation and safety, ensuring that innovative devices can be made available on the market with an additional level of monitoring and control.
The issuance of conditional certificates may apply to medical devices that feature innovative technologies, new clinical indications or significant clinical benefits, but still require rigorous post-market monitoring. Some of the conditions that may be imposed include:
More frequent post-marketing evaluations (Post-Market Clinical Follow-up - PMCF), with mandatory reports at shorter intervals than currently required;
Limitation of use to specific populations, such as paediatric patients or other at-risk groups, until additional clinical data is generated;
Reduction of the certificate's validity period, allowing for earlier re-evaluation of clinical evidence;
Restriction of marketing to specific medical centres, where the technology can be better monitored by specialists.
Team-NB emphasises that this practice already existed under the former Medical Devices Directives (MDD/AIMDD), but was used to a limited extent. Recent studies, such as the CORE-MD Deliverable 3.3 report, highlight the need to expand the use of conditional certificates to foster innovation in the sector and ensure safe and rapid access to new medical technologies. In addition, MDCG guidance 2024-10 recommends that Notified Bodies consider this approach for orphan medical devices, enabling their controlled introduction to the market.
The Team-NB communication encourages all Notified Bodies to evaluate the application of conditional certifications whenever necessary, ensuring enhanced monitoring, collection of real-world evidence, and risk mitigation without compromising patient safety. For manufacturers, this represents an opportunity to introduce innovations to the European market with regulatory support, while complying with more stringent requirements for ongoing clinical evaluation.
