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14:3015:00 19. Nov 2019
14:3015:00 19. Nov 2019 iCal myOrganizer

MTF: Regulatorische Herausforderungen für Forschung und Entwicklung

Session Internationaler Marktzugang und regulatorische Anforderungen

With the EU Regulation 2017/745 (MDR) many already on the market existing medical devices must undergo further clinical testing and/or complex revisions within the conformity assessment. As this requires ample resources, many companies see themselves forced to reduce their product portfolios. This, according to current reports, entails cuts in medical care supply for smaller patient groups, e.g. children.

Article 61 (5) of the MDR only seems to be a possible exit strategy to reduce new clinical testing to a sensible and justifiable extent: It describes an exemption regarding test data for equivalent devices, both within and across companies. The described contractual agreement between different companies to enable data sharing, however, comes close to a feeble joke in the understanding of testing documents as corporate secrets, whose disclosure will be certainly disastrous at the economical level.

Hence, this contribution starts with pure speculation. It starts with a description of requirements that must be fulfilled for companies successfully sharing data. The requirements range from version version control, validity and protection from further distribution to third parties to safety in the case of a discontinuation of business of the data-providing entity. Technical routes for implementation and legal constructs will be discussed.

But to make the flatly unthinkable admissible, we need best practice examples. Those can already be adopted from other industries. The consequence would be a shift in values where not only medical devices are considered as trading goods, but also the product-specific data and validation results, whose licensing to third parties would be economically sensible, even when taking existing competitive products on the market into account. First steps of a route towards this shift will be shown.