Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Sufficient clinical evidence under MDR for legacy devices and new products. Requirements and challenges before and after CE marking.

Dr. Kim Burgard (Abschlußjahr: 2021)

Summary
Language: English
In the European Union (EU) medical devices are regulated by the currently applicable Medical Device Regulation (MDR) in order to assure safety and performance during the medical devices’ lifetime. MDR fully applied on May 26th, 2021 aiming to create a robust, transparent, and sustainable regulatory framework, recognized internationally, that improves clinical safety and creates fair market access for all medtech players.
In comparison to the previous European legislation the Medical Device Directive (MDD) the MDR has implemented new requirements and places more emphasis on a life-cycle approach supported by clinical data. One main aspect of the MDR was to focus on and to concretise clinical aspects and post-market surveillance (PMS) including post-market clinical follow-up (PMCF); requirements for clinical evaluation including the generation of clinical data have significantly strengthened by the MDR. The generation of sufficient clinical evidence will now be key for manufacturers in order to place new products on the market under the new Regulation or to recertify legacy devices under MDR. However, the term "sufficient" is not further defined in MDR and accordingly subject to interpretation. The manufacturer himself has to determine the level of evidence needed for his products.
Within this Master thesis the regulatory framework of the current European, medical device legislation (MDR) as well as the life-cycle of a medical device is first explained. Subsequently, changes in regard to clinical aspects within the new legislation are outlined and compared to the previous legislation MDD. In this regard emphasis is put on requirements for clinical evaluation, PMS including PCMF and clinical investigation.
In a next step the term "sufficient clinical evidence" necessary for recertification under MDR is evaluated for legacy devices, which have lawfully been placed on the market under MDD, and for new products; apart from the current legislation applicable guidance documents are taken into consideration for the evaluation. According to the interpretation as outlined in this Master thesis, it can be noted that an increased quantity as well as quality of clinical data is required in order to demonstrate safety, performance, and a positive risk-benefit ratio. In order to comply with these new requirements and to provide sufficient clinical evidence it is expected that much more clinical trials will need to be carried out.
Since in Europe most manufacturers are small- to mid-sized medical device companies the financial burden as well as the need of qualified clinical personnel in medtech companies may drastically increase. As a result, it can be expected that launching of new, innovative products could take longer, or that product lines may have to be reduced. These aspects are expected to significantly lead to a shortage of medical devices for patients.
Pages: 93