A multi-stakeholder workshop was held by the European Medicines Agency (EMA) on 27th November 2020 for discussion on changes to integral drug-device combinations (products falling under the scope of Article 117 of MDR). These products require Notified Bodies (NB) to be involved in the assessment of device part.
All relevant stakeholders participated to facilitate a virtual interactive discussion. Industry experiences were based on Prefilled Syringes, and Pen Injectors. The industry experience and questions echoed the need for consistency between the review process, details and depth of documentation needed for the review. Intense discussion was surrounding lifecycle management aspects, with a focus on change management, where industry sought more clarity.
The experience of National Competent Authorities (CA) based on the reviews done so far, highlighted that the assessment requirements were well-defined; outlining the details which should be available for NB review and clear outcome of this review. (ex. If the aspects such as shelf life were not completely available for review, the status of partial review was clearly indicated by NB to CA).
The EMA perspective emphasized the need to consider different angles and specific device-related aspects in change management. In addition to guidance on variations, Marketing Authorization Holders are expected to assess intrinsic functional aspects of the device which contribute to the final safety, efficacy and performance of the Medicinal Product, and the impact of any changes on these inherent functionalities.
The NB presentations and responses to questions emphasized the focus of the review, General Safety and Performance Requirements (GSPRs) and data supporting these GSPRs. The data needed could be presented in the form of summaries and supporting documentation might be sought for further review. Example for Biological safety, biocompatibility summary report, along with supplier statements of conformity, assessment of each component and conclusions etc would be needed to assess the compliance.
In summary, the ongoing discussion elaborates the need to formulate documentation in accordance with expectations of the NB. With quite some years of experience with Medical device manufacturers, also with medicinal product manufacturers (under drug device combinations Rule 14), we have been able to assess the needs and understand different perspective and way of working within these two industries. We have engaged in activities in assessing the applicability of Article 117, and effect of such classification on exiting approved medicinal product. In case you can use some support in these challenging new surroundings, please remember that NB submissions and interfacing with EMA/CAs is our key strength, elucidating verification and validation requirements for combination products, usability, biological safety assessments and biocompatibility testing requirements, clinical evaluations, and change assessment specially to understand the impact of changes on the device part. For such support, Qserve can offer significant benefit in drafting submission file, lifecycle management and supporting you through the review process with your NB.
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