The MDR deadline is fixed. Your Notified Body’s capacity shouldn’t stand in your way.

Many manufacturers have already submitted their MDR application and signed a contract with a Notified Body, but are still waiting for the actual assessment of their QMS (Quality Management System) and Technical Documentation.

As MDR transition deadlines approach, waiting on uncertain assessment timelines can become a significant business risk.

ECM CAN OFFER AN ALTERNATIVE

As an MDR Notified Body, ECM can assess, where applicable, whether an MDR application can be transferred from another Notified Body and if the project can be integrated into ECM’s available capacity and scope.

DON’T START FROM SCRATCH. EVALUATE YOUR TRANSFER OPTIONS

A transfer can be particularly relevant when:

• your MDR application has already been submitted;
• you have signed the contract with your current Notified Body;
• the assessment of your QMS and/or Technical Documentation has not yet actually started;
• your current Notified Body is unable to provide a sufficiently clear or compatible assessment timeline;
• your transitional period deadline is becoming a cause for concern.

MDR TRANSFER EVALUATION WITH ECM

ECM can perform a preliminary evaluation regarding:

1. 1. Regulatory Eligibility

Verification of whether the conditions are met.

Verify whether ECM’s MDR designation covers the applicable conformity assessment activities and device characteristics.

3. Project Status

Determine where you stand in the MDR application, QMS, and Technical Documentation process.

4. Capacity and Planning

Verify whether ECM has adequate technical resources and capacity to take over the progress of the project.

5. Transfer Pathway

Identify what information may be required to enter into the transfer agreements between the manufacturer, the current Notified Body, and ECM.

Do you have a clear and credible timeline to complete the MDR conformity assessment before the applicable transitional deadline?

If the answer is uncertain, it may be time to evaluate your alternatives.

ECM: THE ALTERNATIVE FOR YOUR MDR CAPACITY

• Evaluate your options.
• Protect your timeline.
• Keep your MDR project moving forward.

Request an MDR Transfer Evaluation:

Eng. Diego Stevanella ✉ diego.s@entecerma.it (+39) 3932471040