On April 26, 2024, the International Medical Device Regulation Forum (IMDRF) published “Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices“. This document establishes the harmonised essential principles to be observed in the design and manufacture of Medical Devices (MDs) and In Vitro Diagnostics (IVDs) to ensure the safety and effectiveness of the products according to their intended use.
The global adoption of a set of principles touching on fundamental aspects of device manufacturing fully reflects the mission of the IMDRF, which has been bringing together regulatory authorities from different jurisdictions worldwide since 2011 to promote regulatory convergence in the industry globally.
Among the main areas of interest is the fundamental risk management process throughout the product life cycle. It also deals with the Clinical Evaluation process, which, when required, must be able to adequately demonstrate the risk-benefit ratio of the device based on reports of clinical investigations, scientific publications, and clinical experiences.
In particular, the importance of a device’s chemical, physical, and biological properties emerges, and it is emphasised that particular attention must be paid to toxicity, biocompatibility, and flammability when choosing materials and substances. A section of the guideline is specifically dedicated to guidance on the protection of electrical, mechanical and thermal hazards.
The aspects to be taken into account in the process of sterilisation and biological contamination are then discussed in detail, establishing, for example, that the products must be directly designed to facilitate their cleaning and disinfection, to protect user safety.
Appendix 𝗔 outlines the general approach to the use of standards for conformity assessment of a product,
Appendix B links in a table the principles outlined to available guidelines and internationally applicable standards.
The worldwide adherence to a common set of design and manufacturing principles not only provides guarantees of efficacy and safety but also offers significant benefits to manufacturers, users, patients and regulators. Reducing differences between jurisdictions decreases the time and cost to achieve compliance and allows patients earlier access to new technologies and treatments.
>>>> Through its Strategic-regulatory consultancy services, Thema can help you fulfil the regulatory requirements for accessing European and international markets, with activities such as support in obtaining CE marking for Medical Devices and IVDs, international extra-EU registrations of Medical Devices and in vitro diagnostic Medical Devices with foreign Regulatory Authorities.
The proposals also include Quality System Implementation Assistance for Medical Devices and Good Manufacturing Practice (GMP).
Source:
“Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices”
