The EU Commission has recently adopted important regulatory changes impacting in vitro diagnostic medical devices (IVDR). These changes include extended transitional provisions to ensure the continued supply of medical devices in the European market. The new provisions allow manufacturers and notified bodies more time to complete the necessary conformity assessment procedures.

The length of the transitional period depends on the risk class of the devices:

• Class D devices: Market access until December 31, 2027
• Class C devices: Market access until December 31, 2028
• Class B and sterile Class A devices: Market access until December 31, 2029

In addition, manufacturers are now required to notify national competent authorities, distributors, and relevant healthcare institutions of any supply shortages that could cause serious risks to patients. This requirement is designed to provide healthcare services with sufficient time to take necessary actions to ensure patient care is not compromised.

Moreover, the EU Commission has proposed an accelerated rollout of the EUDAMED database, with mandatory use of several modules beginning in Q4 2025.

Adapting to EU Medical Device Regulations

International companies involved in the manufacturing and distribution of medical devices within the EU must swiftly adapt to recent regulatory changes by reassessing their compliance strategies and ensuring all updated requirements are met within the specified deadlines. Staying informed and proactive is essential for maintaining market access and ensuring continuous patient care in the EU.

The regulation has already been adopted and is in effect within the EU, with the process of incorporating it into the EEA Agreement currently underway.

Contact Mericon for Expert Support on Regulatory Changes

Should you have any questions in navigating these regulatory changes, Mericon is competent with extensive experience in regulatory compliance. We encourage you to contact us for professional support and guidance.