Client Background:

The manufacturer is producer of Class III devices which are flexible, hollow tubes called colonic stents. The manufacturer of Class III Colonic stent is intended to treat obstructed sections of the large intestine, through a procedure called colonic stenting is used. A technique known as stent placement is used to expand and open the blocked colonic section. It is most effective for people with colon cancer or other types of bowel obstruction.

Client Problem:

As the device belongs to the class III, they needed to submit the CER. Their old CER was based on MDD whereas they needed new CER based on MDR. They had already contacted with one consultancy but were not satisfied with the timeline and quality of work.

ND Global Solution & Approach:

ND Global developed CEP and CER on MDR-compliant templates in accordance with the MDCG and IMDRF guidance documents on MDCG 2020-13 Clinical evaluation assessment report. The customer received a thorough Gap Assessment from us and consultation support to close any gaps in their prior Clinical Evaluation for compliance with MDD. ND Global also broadened the scope of the EU MDR Gap Analysis to offer advisory consultation for MDR compliance.

Project Achievements:

Based on their positive experience, the customer extended the scope of work to seek support for MDR-compliant documentation for this device as well as the second device, a Class III medical device.

Project Outcomes:

The devices received CE Marking after the Notified Body reviewed and accepted the clinical evaluation documents for both devices without making any observations.