Certificates with Conditions – Team-NB proposal under MDR and IVDR
Conditional certificates allow innovative medical devices and IVDs to reach the market under specific limitations or follow-up obligations. Team-NB highlights their potential to support faster access while maintaining safety. This flexible regulatory tool remains underused and deserves wider application under MDR and IVDR. The position paper encourages notified bodies to apply this pathway more systematically.
What is a certificate with conditions?
According to Annex VII of MDR (and by analogy IVDR), notified bodies may issue a certificate on the condition that additional requirements are met—such as restricted indications for use, a defined target patient population, or the obligation to provide Post-Market Clinical Follow-up (PMCF) data. Certificates may also be granted for a reduced validity period or require periodic reporting.
When is conditional certification appropriate?
Conditional certificates are particularly relevant for devices that are:
- innovative or considered breakthrough technologies,
- addressing unmet clinical needs,
- subject to limited clinical evidence at the conformity assessment stage,
- requiring rapid market access under enhanced post-market surveillance.
Examples of possible conditions
Certificates may include provisions such as:
- submission of PMCF data every 6 months,
- exclusion of certain populations (e.g., paediatrics),
- restricted use to designated healthcare institutions,
- mandatory inclusion in a clinical or user registry,
- shorter certificate validity (e.g., 3 years).
Team-NB position and CORE-MD reference
The Team-NB paper references the CORE-MD D3.3 report, which highlighted the limited use of conditional certificates under the previous Directives and called for greater adoption under MDR. The association encourages notified bodies to apply this pathway under section 4.8 of Annex VII. It also cites the European Commission’s endorsement expressed in MDCG 2024-10 concerning orphan devices.
Why this matters?
Certificates with conditions offer a way to balance patient safety with timely access to innovation. By enabling controlled market entry, this approach supports the availability of novel devices while maintaining regulatory rigour. It represents an opportunity for manufacturers, patients, and healthcare systems across Europe.
Team-NB Statement – Certifications with Conditions