Setting the Scene: the regulatory impact on requirements for performance of plastics and rubber materials in medical devices
While the EU Medical Devices Regulations (MDR) does not specifically mention polymer materials, it does impact on the chemical, physical and microbiological requirements for performance of polymer materials, including sterilisation and bio-burden. This section will provide an overview and guidance on the parameters and impact of the regulations with regard to plastics and rubber materials.
Overview of the EU Medical Devices Regulations(MDR)
Medical Devices and accessories are subject to classification rules according to the degree and time of contact with the patient. An explanation of the classification system will be given. The relationship between Medical Device classification and European Standards such as ISO10993 and harmonised European Standards will be discussed.
Quality Management Systems for Medical Devices
An overview of the Quality System Standards ISO13485 and ISO9001 will be presented, with a focus on the sections of ISO13485 that address essential requirements of the Medical Devices Regulations.
Introduction to the Medical Device Risk Assessment Standard ISO 14971
ISO14971 is an important harmonised standard that details the requirements for the application of a risk management system for medical devices. The last revised version: ISO14971:2012 applies to manufacturers placing medical devices on the market in Europe. An overview will be given of this medical device risk management standard, which will explain the actions that should be taken to meet the requirements of this standard.
Material Selection for Medical Devices, including sterilisation methods and their impact
A review of the different types of plastics and rubber materials which can be used for medical devices and accessories. A method of material selection criteria will be explored focussing on the special considerations needed to ensure a device performs safely. An important consideration is disinfection or sterilisation.
Manufacturing environment for Medical Devices: options and requirements
An overview of the manufacturing arrangements needed for medical devices and where these differ from other products.
An overview of biocompatibility and types of testing
An overview will be given which will provide a general introduction to the subject and the types of tests that can be employed to assess the interaction between medical devices and patients. The contents and scope of the international biocompatibility standard, ISO 10993 will be included and a comparison provided of how the EU and USA/FDA biocompatibility testing requirements and application of this standard differ from one another.
Packaging Systems for Medical Devices
Medical Devices are required to provide the desired function after they have passed through the distribution system from manufacturer to patient. Packaging systems are an integral part of the function of a medical device. Requirements for packaging systems will be discussed with reference to performance specified by European Standards, including integrity and testing.