Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

New challenges for medical device manufacturers: Implementation opportunities for post-market surveillance regarding the new MDR 745/2017 requirements for medical devices

Dr. Veronika Bernek (Abschlußjahr: 2019)

Summary
Language: English
In this master thesis, the new requirements of the Medical Device Regulation 2017/745 (MDR) on post-market surveillance and the resulting challenges for manufacturers were considered. In addition to the changes to the previously valid Medical Device Directive 93/42/EEC (MDD), the new life cycle approach and the individual phases of MDR transition and implementation challenges for Notified Bodies were also presented and discussed.
In this respect it was found that there is an increased emphasis on Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) data under the MDR, in addition to new and expanded requirements. The MDR applies in May 2020, and at this point the manufacturers will be obliged to fulfill all requirements regarding PMS and vigilance for their products. Post-market surveillance is noticeably strengthened under the MDR and manufacturers will be required to implement a proactive, continuous and systematic risk-based system to collect data over the entire life cycle from medical devices already circulating on the market. The PMS-System covers the collection of reactive data for vigilance purposes and of proactive data for post-market surveillance activities. Possible data that should be gathered by the PMS have been described and discussed.
The PMS-System for each device must be planned, maintained, documented and updated in the quality management system. The PMS Plan includes evaluating and monitoring of corrective and preventive actions, conducting regulatory reporting in specified timelines, trend reporting, device improvement, evaluating of other relevant products and updating technical documentation, risk management, the risk/benefit profile of the device, and all PMS-Reports. The prerequisites and contents of the PMS system - vigilance and PMS - were described in detail and the connections to other legal requirements and standards were pointed out.
In addition, all new requirements regarding PMS were presented and discussed in detail. This includes the requirement for each device to have a Unique Device Identifier (UDI) to reach complete traceability and that the UDI as well as PMS and vigilance data should be collected from March 2020 in a new database, the EUDAMED. Another new demand of the MDR is the person responsible for regulatory compliance (PRRC), which shall ensure that all PMS obligations are respected.
All classes of medical devices are concerned by PMS, but obligations are bigger for higher risk classes: For class I devices, a post-market surveillance report (PMSR) summarizing the results and conclusions of the analyses of the PMS data and any corrective or preventive action taken will be required; for class IIa, class IIb and class III devices a periodic safety update report (PSUR) of each device, including conclusions of the benefit-risk determination, main findings of the Post-market clinical follow-up (PMCF) and the volume of sales will be required. The PMSR has to be updated when necessary, whereas the PSUR for class IIa shall be updated biannually and for class IIb and III annually. Manufacturers of implantable devices and class III devices shall also draw up a summary of safety and clinical performance (SSCP), which includes all major clinical data processes (clinical evaluation, PMCF and PMS) and will - together with the PSUR - be made public through EUDAMED.
However, manufacturers are faced with major challenges in implementing the PMS system because the requirements outlined in the MDR carry significant process challenges and procedural updates. Both, general challenges and challenges regarding PMS were considered and the possible consequences discussed.
The overwhelming mass of new requirements -PMS, intensified clinical evidence and NB designation -connected with the obligation for re-certification of all devices will probably result in a rigorous portfolio assessment and be a great financial burden particularly for small companies. It is therefore important to establish a pragmatic and systematic retrieval of PMS data from various sources in the company. Apart from post-market surveillance, the concept should also address and be connected to clinical evaluation, quality management and risk management.
As part of this thesis, five templates were created to provide a feasible example for the implementation of a working PMS-System, including templates for plans (PMS- and PMCF-Plan) and reports (PMSR, PSUR, PMCFR).
Pages: 61,
Annexes: 5, Pages: 52