Background

A global medical device manufacture needed to meet the May 26, 2021 EU MDR compliance deadline. Collecting the reference documentation from suppliers was a challenge due to their geographic location. Based on the new CE mark requirements, the client moved from a self-submission filing status, to a Class 1 medical device.

RCA Approach

RCA collaborated with the client’s leadership team to create a cohesive strategy based on the new EU MDR regulatory environment. Training sessions were conducted to educate their team on the changes from MDD to MDR.

RCA performed an assessment to understand the current state and identified all gaps that existed in relation to the new EU MDR. This included a review and assessment of the existing Design History Files (DHF) and the Quality Management Systems (QMS). It was identified that the documentation was in several locations and lacked the efficiency of a culture of quality.

A Project Plan was developed that outlined the creation or revision of 12 Standard Operating Procedures (SOP), along with the development of complete design history files for 3 current/legacy product families. Clinical Evaluation Reports were created for 3 product families to help the client determine their new MDR classification.

RCA increased the efficiency of the documentation process so a single hub of information was available for future assessments or audits. Change control processes were implemented to improve how revisions of SOP’s and quality records were documented.

Results

RCA successfully delivered submission files for the 3 product families on time. This enabled the client to continue their business under normal operating conditions in each global market.

Packaging validation was also optimized based on improved procedures that met the new MDR regulatory guidelines. Supply chain partners and suppliers were educated on the client’s new requirements for optimized validation protocols.

Finally, RCA helped the client identify additional opportunities to optimize their QMS and product portfolio based on the new regulatory environment. This led to the potential for expansion opportunities based on the current certification approval.

Client Takeaways

• Technical files for EU MDR submission were optimized including generation or updates for every element of the file.
• The Client successfully transitioned to ISO certification.
• One of the client’s suppliers was impressed which led to additional assessment projects with vendors in the client’s model.