Depending upon the application and classification of a medical device and/or accessories, the use of a plastic or rubber material in its manufacture may require consideration of biocompatibility, traceability, sterilisation techniques and their impact, manufacturing environment, regulation and testing, in addition to the engineering requirements and capabilities of the material to be used.
This course will concentrate on providing an introduction to the material requirements and manufacturing conditions which may apply and will explore the scope and impact of the European Medical Device Regulation (MDR) in relation to their use.
This course will take place over two days, commencing at 9.15am on the first day and finishing at 3.30pm on the second day.
- Gain an awareness of the scope of the EU Medical Device Regulations and its impact
- Understand what is classified as a Medical Device
- Appreciate the essential differences between quality systems ISO 9001 and ISO 13485
- Gain detailed awareness of the additional technical criteria which apply in the selection of medical grade polymer materials
- Understand the options for sterilisation and their impact on different plastics and rubber materials types
- Discover the different options for testing for biocompatibility, when to use them and what they will reveal
- Appreciate the general requirements for manufacturing medical devices, depending upon classification and type
Setting the Scene: the regulatory impact on requirements for performance of plastics and rubber materials in medical devices
Overview of the EU Medical Devices Regulations(MDR)
- 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.
Quality Management Systems for Medical Devices
- 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.
Introduction to the Medical Device Risk Assessment Standard ISO 14971
- 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.
Material Selection for Medical Devices, including sterilisation methods and their impact
- 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.
Manufacturing environment for Medical Devices: options and requirements
- 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.
An overview of biocompatibility and types of testing
- An overview of the manufacturing arrangements needed for medical devices and where these differ from other products.
Packaging Systems for Medical Devices
- 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.
- 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.
Who will benefit
- Moulders and fabricators considering supplying medical device companies, typical roles may include: Technical Managers, Quality Managers, Others needing insight into the material and manufacturing and quality systems requirements and scope of MDR which may apply when making medical devices or medical grade materials.
- Existing suppliers or medical device manufacturers with little or no experience of engineering with plastics or rubber materials, typical roles may include: Designer/Engineers, Technical/Production managers, Others needing to understand the additional material specific considerations, the scope of the MDR in relation to their use and how these may differ from traditional engineering materials.
What our delegates say
"Very helpful and professional, would recommend to others"
James Wingham (University of Sheffield)
"Useful with a lot of information"
Sara Pintado del Campe (GSK)
Questions and queries
Please contact Kerry Haralambou