Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Proposal for a Harmonised Structure of Technical Documentation and basic Functionalities of a Submission Software Tool under EU-MDR ***

Nicole Heumesser (Abschlußjahr: 2020)

Summary
Language: English
Being one of the biggest markets for medical devices, the European Union obliges the medical device industry to undergo major changes for the transition to the new legislative framework for medical devices, the European Medical Device Regulation ('EU-MDR').
One of these changes is the adjustment of existing technical documentation to address all requirements outlined in the EU-MDR, impacting not only manufacturers but also notified bodies and competent authorities. Using this momentum, existing were evaluated to find a structure not only meeting the requirements of the new EU-MDR, but also reducing the complexity of writing and assessing the technical documentation by harmonisation. This proposal requires to also cover each medical device, independent of risk classification, purpose, duration of treatment, invasiveness, form, size or other attributes. To what extent software tools can be helpful to reach conformity was assessed, too, resulting in additional requirements from the IT point of view.
Within this thesis, it could be outlined that amongst several existing proposals, the Non-In Vitro Diagnostic Device Market Authorization Table of Contents structure ('ToC') – published by the International Medical Device Regulators Forum IMDRF in 2019 – covers all individual requirements that are defined in the Annexes II and III of EU-MDR for technical documentation. A conducted evaluation even showed that for almost 50% of the requirements, a one-to-one relationship between the EU-MDR requirement and the chapters of the structure is existing. Besides software as medical devices, all other devices – no matter what attributes and special conditions they are in (e.g. single use, biological origin, sterile, reusable surgical, implant) – did not differ much regarding the individual content to be provided within a technical documentation, proving the feasibility of the ToC structure for covering all styles of medical devices under EU-MDR.
The aim of the thesis to provide a uniform structured technical documentation that will be well-accepted by all involved parties is met as the evaluation supports a document that was created to even harmonise the documentation of the quality and safety of a device on an international level.
While conducting this evaluation for the structure itself, a proposal for a not yet existent Classification Matrix for the EU could be made, closing an existing gap by providing guidance on whether individual chapters of the ToC are required, conditionally required or not required.
The thesis substantiates the feasibility of the structure under the new legislative framework and provides a contribution to the creation of an official Classification Matrix. The final creation of the matrix lies within the duty of the European Commission and will clarify whether chapters of the ToC structure, where no final decision based on the content of the EU-MDR could be made within the thesis, will be required or not.
Even though some of the expectations and requirements identified and discussed could be addressed by the ToC structure, there still was more than half of the requirements stipulated in Annexes II and III of EU-MDR not yet covered. A software was identified to be helpful to close these gaps and the main features necessary to do this were outlined. Addressing further requirements for software development would go beyond the scope of this thesis, but it is providing additional thoughts that should be taken into consideration when addressing this gap, which software providers has already started to address.
Interaction between structure, methods and regulatory intelligence was found to be providing a chance for further streamlining of processes, resulting in time and cost savings.
Even though every manufacturer on the market has already created technical documentation following individual structuring approaches in the current structure and every NB has built processes supporting their own recommended structure, investing time to re-organize documents to fit the ToC structure will be reasonable. It is better to adapt changes and build a new and sustainable structure, supported by a streamlined process rather than to continue with old methods and find supposedly smart workarounds to close obvious gaps to meet requirements outlined by EU-MDR instead.
Pages: 57
Annexes: 8, Pages: 116