On 12 March 2025, Team-NB released a statement on certificates with conditions. The EU Medical Device Regulation (MDR) 2017/745 and the In-Vitro Diagnostic Regulation (IVDR) allow notified bodies to issue certificates with specific conditions, provisions, or limitations. Notified bodies must have documented procedures for issuing, suspending, restricting, or withdrawing certificates while adhering to notification requirements. Certificates can be valid for up to five years and may include specific conditions to ensure safety and compliance. This practice was also allowed under previous Directives.
Using specific conditions on certificates supports innovation while ensuring patient safety by controlling the release of novel devices. It also facilitates the rapid collection of data to complement clinical evaluations.
Conditions, limitations, or restrictions: examples
Some examples of specific conditions, limitations, or restrictions on a certificate could include:
- Requiring interim PMCF surveillance (e.g., every six months) outside standard reviews based on a contractual agreement between the notified body and the manufacturer.
- Restricting the device’s intended use (e.g. within a certain population).
- Reducing the certificate validity (e.g., from five years to three years).
- Limiting the device’s sale to specific medical institutions with trained personnel.
- Mandating the input of safety and performance data into a registry.
MDCG Guidance 2022-14 supports the use of such certificates, particularly concerning PMCF/PMPF (Post-Market Clinical and Performance Follow-up) studies. More recently, MDCG 2024-10 encouraged notified bodies to consider this option for orphan devices.
Certificates with conditions to support innovation
A recent CORE-MD report, “Reports on Conditions on Certificates by Notified Bodies Deliverable” highlighted the limited use of such certificates under previous medical device directives but emphasised their value in supporting innovation. The report encourages increased use under the MDR. TEAM NB acknowledges this and urges its members to consider applying specific conditions, provisions, or limitations to certificates under MDR and IVDR (Annex VII section 4.8). This approach helps ensure that innovative, new, and orphan medical devices remain accessible while maintaining appropriate surveillance safeguards.
Do you have questions on MDR and IVDR certificates? Contact us here or at mdlaw@obelis.net.
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