Preparation of Technical Documentation for Class III Substance-Based Medical Devices

This project involved a comprehensive update and adaptation of the technical documentation for two Class III substance-based medical devices — an ear spray and ear drops — originally certified under the MDD. The main objective was to align all documentation with the requirements of Regulation (EU) 2017/745 (MDR) and to address all Notified Body observations raised during the review process.

From the coordinator

“The success of this project relied on the precise integration of biological, preclinical, and clinical data into a coherent MDR-compliant framework. Addressing each Notified Body comment with scientific rigor was key to achieving seamless certification.”

PROJECT COORDINATOR Katarzyna
Romaniszyn Head of Regulatory and Quality Management Department

Challenges

Ensuring full alignment of biological, preclinical, and clinical evidence with MDR Annex II and III requirements.

Updating the General Safety and Performance Requirements (GSPR) checklist and risk management documentation to reflect current standards.

Addressing detailed Notified Body comments on data integration and the scientific justification of the substance-based mechanism of action.

Project details

The project encompassed a full revision of MDR-compliant technical documentation for two high-risk, substance-based otologic medical devices. The Pure Clinical team performed an in-depth gap analysis between existing MDD files and MDR requirements, identifying missing evidence and necessary justifications.
New evaluations were performed or updated in accordance with MDR Annex I and MDCG guidance on clinical evaluation and risk management. The process included a detailed review of the product’s mechanism of action, toxicological and biocompatibility updates, and a critical appraisal of clinical data supported by a literature review.
Close collaboration with the client and the Notified Body ensured that all scientific and regulatory aspects were comprehensively addressed, resulting in a smooth and timely MDR certification.

Results

All sections of the technical documentation were successfully revised, including biological and preclinical evaluations, risk analysis, clinical evaluation report, and GSPR mapping.

The updated documentation met MDR conformity assessment criteria for Class III devices.

The client successfully obtained MDR certification for both products, confirming the robustness of the documentation and regulatory approach.

Key findings

Integrating biological, preclinical, and clinical data ensures a smooth MDR certification process.

Katarzyna Romaniszyn

Project Manager

I will help your company in developing:

medical devices

regulatory affairs

quality management

ISO 13485

UDI

risk management

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