Actalent Helps Client Maintain $20 Million of its Market Share by Securing Approval of its EU Product Lines

man with laptop reviewing data

Leader in Sports Medicine and Rehab Products Successfully Navigates Strict New EU Medical Device Regulations (MDR)

Results at a Glance

Gained approval of technical files avoiding a loss of $20 million in revenue

Gained an advantage over competitors that were less quickly able to secure approval

Established a sustainable, successful long-term approach to future audit and regulatory compliance

Client Profile

Our client is the largest, world-wide, branded distributor and manufacturer of specialty rehabilitation, recovery, and sports medicine products. Their portfolio of products and devices -- ranging from stretch bands and exercise balls to home neuropathy tests and cognitive performance kits -- are manufactured and distributed for use in homes, offices, hospitals, and clinics.

Market Overview

Medical device manufacturers marketing and distributing products in the European Union are now subject to stringent and enhanced compliance requirements that are meant to improve quality, safety, and reliability of those medical devices. Strict risk categorisation, post market surveillance guidelines, conformity assessment, and information/labeling transparency are just a few of the changes required after the repeal of the Medical Device Directive (MDD). The new uniform directive of Medical Device Regulation (MDR) requires greater scrutiny of technical documents, clinical evaluation, and post-market clinical follow-up. Compliance with the MDR is a serious challenge to medical device manufacturers and distributors around the world. If found noncompliant with the MDR, corporations can face fines, product recalls, and other disciplinary action that can severely affect market share and corporate reputation.

The Challenge

Our client sought to reach compliance with the MDR by May 2022, otherwise it risked the distribution of more than 1,500 products and $20 Million in annual revenue. Furthermore, non-compliance with the MDR would drastically affect the people who rely upon the availability of rehabilitation equipment.

With a scarce labor market exacerbated by a global pandemic, the client found it extremely difficult to identify key professionals with the necessary regulatory and quality background to ensure they complied with the stricter MDR regulations.

The Actalent Approach

Actalent leveraged our regulatory experience with EU MDR to provide a robust solution perfectly tailored to the clients need. Our skilled project team consisted of technical experts who had previous exposure to MDR compliance. Led by a seasoned Medical Device Project Manager, we aligned two Quality Assurance Specialists, two Regulatory Specialists, two Labeling/Graphics Specialists, and a Technical Writer to remediate 10 technical files quickly and efficiently, as well as much needed labeling changes.

After defining a technical file and Design History File Gap Assessment, our team got to work providing high-level regulatory guidance, creation of risk and post-market surveillance documentation, remediation/creation of technical files, communication/submission with the Authorised Representative, creation of Declaration of Conformity, a complete overhaul of label-copy, and new content and artwork. Our team operated within the client’s established Quality Management System (QMS) and efficiently worked with the client’s in-house regulatory and quality teams.

This partnership permitted our client to optimise their internal resources while leveraging our team to ensure MDR compliance. We successfully implemented the MDR standards for all 10 technical files (1,641 SKUs) under budget and ahead of schedule. Our partnership greatly reduced the level of financial exposure with the client’s EU product lines, giving our client a competitive advantage in the marketplace. Furthermore, the successful results of three regulatory audits conducted by an Authorised Representative at three client sites were directly attributed to Actalent’s remediation efforts. Our client not only consistently praised our professionalism, transparency, timeliness, and overall quality of work, but has continued to engage Actalent for additional project initiatives.

The Results

The Authorised Representative (AR) approved our client’s technical files so to secure continued marketing of all 1,641 product codes, as well as avoiding a loss of over $20 million in annual revenue.

Aside from revenue loss products being removed from sales and distribution, the client avoided a reputational loss due to non-compliance with the MDR. By complying with the MDR and quickly introducing both existing and new products for marketing and distribution, retailers in the EU have confidence in the client’s product availability over competitors that were yet to be approved.

Operationally, the client successfully pursued MDR compliance without sacrificing internal initiatives and critical functions essential to their operation. With the assistance of Actalent, the client achieved a more cost-effective labeling process, greatly reduced risk to current and future audits, and achieved a more sustainable approach to compliance.