This module is designed to cover the major issues affecting the development and regulatory control of medical devices and in vitro diagnostic devices. This module can be broken into five main parts of 2 sessions each, which is 10 sessions overall. The sessions are designed to set the general background to the development and regulation of medical devices and diagnostics internationally. In the tutorials, the student will specifically focus on the regulatory perspectives of medical devices and diagnostics.
Although there are variations in how medical devices and diagnostics are regulated across countries, the regulator’s intentions and tasks remain the same; that is, to uphold the law of the land and ensure the protection of users. Regulators also provide the practical framework that enables the law to be upheld and in which users can be protected. There is also a concerted international effort to harmonise the regulatory approaches, which will be covered later in the module.
It is also the regulator’s role to read the rapid developments in the field and accommodate these developments with up-to-date legislation or up-to-date interpretation of the legislation.
Where necessary, guidances are issued by the regulators to guide users on the use of the regulations. The student will be shown many examples of these in the module.
The role of the regulator in this module should be read as an arbiter and as a facilitator. It is to the advantage of users, manufacturers and regulators, acting on behalf of society, that the regulator provides a fitting and working regulatory regime to enable novel products to be marketed as early as possible. Equally, the regulator should provide and manage a vigilance system for device products. The regulatory regime needs to ensure that products that pose a threat to users are removed from the supply chain.
The regulator has to operate within the confines of the law. Laws take time to be adjusted or created. New laws need to satisfy as many stakeholders as possible and stakeholders will generally make representations to advance their cause. There is always a balancing act when new laws are generated.
Developers of devices and their manufacturers represent key stakeholders. It is in the interest of the developers and manufacturers to reconcile their commercial interests with the needs of society and the standards that society expects from those who stand to gain financially. The student will see a case where the regulators have been castigated for failing to manage the manufacturer’s interests.
Reading and analysing this subject will require the student to:
Conceptualise the development, use, practice and regulation of in vitro diagnostic devices and medical devices in terms of norms that are different to those typically applied to medicines
Recognise the difficulties of regulating medical devices and in vitro diagnostic devices that include classes of products that can be widely different from each other and that have widely different uses
Recognise the difficulties of regulating products that can be increasingly easily traded across national frontiers
Reconcile regulatory norms that are not as harmonised as for medicines
Intended Module Learning Outcomes
On completion of this module, the student should be able to:
Determine and contextualise the major issues affecting the development of medical devices, mainly, and in vitro and diagnostic devices, secondarily
Describe the regulatory control of medical devices and in vitro diagnostic devices with special reference to the European Economic Area (EEA) European Conformity (CE) mark and other key international legislation
Review from an international perspective standards for conformity assessments, safety and risk assessments and assessments of medical devices containing drugs and the latest developments in in vitro diagnostic devices
Review the issues arising regarding the marketing and quality of devices and diagnostics from the perspective of traceability