EU MDR & IVDR: Certificates with Conditions to Support Innovation

The EU Medical Device Regulation (MDR) 2017/745 and the In-Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746 provide a mechanism that allows notified bodies to issue certificates with specific conditions, provisions, or limitations. This process is designed to support innovation by enabling the release of novel devices under controlled conditions, ensuring patient safety while simultaneously gathering essential real-world evidence.

Key Points

• • Regulatory Framework: Both the MDR and IVDR include provisions for issuing certificates with conditions as outlined in Annex VII, section 4.8.
  • Examples of Conditions: These conditions may include interim surveillance of Post Market Clinical Follow-Up (PMCF) activities, limitations on device use to specific populations or institutions, restricted certificate validity, and the requirement for mandatory data input into registries.
  • Guidance and Support: Recent EU Commission guidance (MDCG 2022-144 and MDCG 2024-10) encourages the use of these conditions, particularly for the clinical evaluation of orphan devices. Both Team-NB and CORE-MD endorse this approach to promote innovation while maintaining the highest safety standards.

Encouraging Innovation

TEAM-NB urges its members to consider issuing certificates with specific conditions under both the EU MDR and IVDR, in line with Annex VII, section 4.8. This framework allows for innovation in the medical device sector without compromising on safety and patient protection.

For more detailed information, please refer to the following documents:

• • Press Release – Certificates with Conditions
  • CORE-MD Guidelines

For guidance on EU MDR IVDR certificates with conditions, contact us today.