Client

Global medical device organization based in the USA in need of EU MDR support. 

Project Timeline

Regulatory Documentation – 4 weeks

Clinical Evaluation Report – 6 weeks

EU MDR Submission – 4 months

Client Challenge

A global medical device firm needed to meet the regulatory EU MDR compliance deadline. Collecting the reference documentation from suppliers was a challenge based on localities. Based on the new CE mark regulatory articles, the client moved from a self-submission regulatory status to a Class 1 device, and the new regulatory information was needed.

Regulatory Compliance Associates Approach

Preparation and consulting time was spent with the client’s leadership team to create a cohesive strategy based on the new EU MDR regulatory environment.

Regulatory Strategy

Training meetings were conducted between Regulatory Compliance Associates life science consultants and the client to explain the new changes from MDD and MDR, and what path to regulatory compliance was needed. The current state assessment involved the Design History File and the current state of QMS.

Standard Operating Procedure (SOP)

A Project Plan was developed that outlined the development or revision of 12 Standard Operating Procedures, and the development of complete design history files for 3 current/legacy product families. Clinical Evaluation Reports were conducted by Regulatory Compliance Associates MDR consultants for three product families to help the client better support their new MDR classification.

Quality Management System (QMS)

The client’s QMS was investigated by Regulatory Compliance Associates^® medical device consultants to confirm alignment between the quality manual and existing standard operating procedures. The documentation had been located in many places and lacked the efficiency of a culture of quality.

Change Control

Regulatory Compliance Associates increased the efficiency of the client’s documentation process so a single hub of information was available for future assessments or audits. A change control process was implemented to improve how revisions of SOPs and quality records followed the updated MDR regulations. 

Results

The client’s EU MDR submission for the three product families was delivered on time. The client could continue their business as normal operating conditions in each global market.

Packaging Validation

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.

Portfolio Analysis

Finally, Regulatory Compliance Associates^® helped the client identify additional opportunities to optimize their QMS and portfolio decision analysis based on the new regulatory environment. This led to a portfolio analysis of where expansion opportunities may exist based on the current certification approval.

Client Takeaways

• Technical file for EU MDR submission was optimized including generation or updates for every element of the file.
• The client is now moving toward ISO certification
• One of the client’s suppliers was impressed with Regulatory Compliance Associates in working with our team. This led to additional assessment projects with vendors in the client’s model.
• The client enjoyed working with the entire Regulatory Compliance Associates team and vendors who were a part of the process have now engaged RCA to help their organization.

 

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