Challenges for the Regulatory Affairs Function in Demonstrating Compliance for Existing CE Marked Devices to the New EU Medical Devices Regulation 2017/745 /

Abstract

The Medical Device industry in Europe, and specifically Ireland, is a critically important manufacturing sector underpinned with strong potential for further growth in the coming years. To place any Medical Device on the European Market, manufacturers must comply with all applicable regulations. The introduction of new EU Medical Device Regulation in Europe, Regulation (EU) 2017/745 of the European Parliament and of the Council 05th April 2017 on medical devices has left the sector struggling to both fully understand the new requirements facing it and, more importantly, ensuring that it can fully comply with same by May 2020. The aim of this research is to outline the key challenges for the regulatory affairs professionals in implementing the changes introduced by MDR 2017/745, and the impact it is having on industry and regulators alike. At the time of this print there is only one year remaining of the available three-year transition period. Manufacturers have until May 2020 to be fully compliant, leaving many with a significant amount of work still to do given the significantly increased regulatory requirements now facing them under MDR 2017/745. As well as an in-depth literature review, a mixed-method approach was used to gather information from industry regulatory professionals from both the Medical Device manufacturers themselves and the Regulatory Agencies overseeing them. Interviews were conducted with twelve of these professionals with a survey then created for use with a wider, industry-based audience to ascertain the impact and importance of the various challenges identified during interview. This research identified the primary challenges the introduction of MDR 2017/745 will bring to the MedTech sector. During the survey phase, challenges identified during interview were ranked by respondents with results used to identify and understand implications of the primary challenges facing regulatory professionals as they move to implementation of MDR2017/745. This research will aid manufacturers understanding of MDR 2017/745 and help with planning and implementation of this new regulation.