Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Does the SSCP bring the desired transparency for the European patients and the general public - Critical Assessment from an industry perspective

Anna Magg (Abschlußjahr: 2020)

Summary
Language: English
The new European Medical Device Regulation 2017/745 (MDR), entered into force on 26 May 2017 amended by the Regulation 2020/561 on April 24th 2020, residues with a series of new requirements for the manufacturers of medical device.
The existing legislation for medical devices, the Medical Device Directive 93/42/EEC (MDD) and the Active Implantable Medical Device Directive 90/385/EEC (AIMD) remain fully legally applicable until the replacement by the new MDR on 26 May 2021. A specific guideline MDCG 2019-09 was provided by the Medical Device Coordination group, that should provide assistance to the medical device manufacturers in creating an SSCP. Still, there are many uncertainties, that need clarification before the final date of application. To some extent, the requirements described in the MDR and especially the MDCG document are not described comprehensively.
In this master thesis, the new requirement of the Medical Device Regulation 2017/745 (MDR), especially the creation of a summary of safety and clinical performance (SSCP) and the resulting challenges for manufacturers were considered and its potential impact on the transparency and the European public was discussed.
The findings reveal that although there are guidance documents to provide help, the medical device manufacturers are still left with much legal uncertainty and the notified bodies with too much scope if interpretation, resulting in different interpretation of the law between different notified bodies. Therefore, a basis for a harmonized decision making among the different notified bodies should be set in place. By giving a clear presentation of what kind and the depth of information is expected by the notified bodies an unequal distribution of information between the companies is ensured avoiding an excessively control by the competitors.
The number of current notified bodies is also seen as a bottleneck for the availability of medical devices on the market.
Due to the high number of medical devices available on the European market, the expected big amount of data provided to the broad public with the SSCP, even when written in lay language, will not be easy to comprehend. In this respect it was found that there is an increased risk of information overload and it is of a substantial importance to reconsider the depth of information being provided to the patient. A further identified risk is the disclosure of sensitive manufacturer data followed by the danger of non-appearance of investigations into new innovations.
Pages: 44