EU MDR Regulatory Submissions

Background

Our client, a Fortune 500 medical device manufacturer, identified hundreds of product families in need of preparation for the transition from the European Medical Device Directive MDD to the EU MDR regulation.

The objective of the engagement was to provide regulatory support to facilitate the company's transition from the European Medical Device Directive MDD to the EU MDR regulation. The client indicated that product technical files and design dossiers will need to be updated to comply with the EU MDR technical documentation requirements and, in some instances, submitted to the Notified Body.

Approach and Solution

ECI assigned four regulatory resources to help define the structure required to meet the requirements defined under the new MDR regulation. The client has identified the need for Notified Body review of over 30 product files and corresponding support for the preparation of Technical Documentation, and over 50 files not requiring direct Notified Body review.

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Comprehensive Action

Activities included confirmation with the client regarding updates to the client's Quality Management System (SOPs and Work Instructions) to ensure compliance with MDR requirements. In turn, these updates compelled the creation or updating of product technical documentation (i.e., product test reports, IFUs and labeling; design and manufacturing specifications).

The team implemented a strong process to support compilation, review and final submission as well as tracking the Notified Body review status and responses.

ECI regulatory consultants provided regulatory support to a cross function team producing the required submission deliverables. This included review and approval of Change Notices (CN) to update design history file documents such as Design Input/Design Output Requirements, Clinical Evaluation Report, Packaging Reports, Risk Management and Usability Reports. Tools were generated to support the submission process and reporting Notified Body feedback trends.

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Results

This multi-year effort was initiated in September 2020 and is ongoing.

To date, over 300 CNs (change notices) have been reviewed, and over 15 MDR Technical Documentation files (including General Safety and Performance Requirement (GSPR) summaries) have been updated by ECI consultants.