ADAMAS recently held an internal training session for all their consultants on the topic of Investigational Medical Devices (IMDs). This was run Dr Joerg Holzinger, ADAMAS’ ‘subject matter expert’ in response to an increasing number of enquiries for assistance in this area of clinical trials, and updates to relevant ADAMAS standard operating procedures. In the EU, the legislation for medical devices is covered in three directives referring to medical devices (93/42/EEC), in vitro medical devices (98/79/EEC) and active implantable medical devices (90/385/EEC). Medical Devices fall into a number of classes, with the stringency of regulation increasing as the classification increases. Class I devices are non invasive devices and include spectacles. There are sub- divisions of class I; class ‘Is’ covering steriles and class ‘Im’ for those devices with a measuring function. Class IIa generally consists of surgically invasive devices intended for short-term use, such as contact lenses. Class IIb covers a wide range of devices, and continuing the ocular theme for example includes devices used for cleaning or disinfecting contact lenses. Class III again includes a wide variety of different devices including any for use in the heart or central nervous system.
ISO 14155: 2011 is essentially the equivalent of ICH GCP for IMD studies. All those elements familiar to auditors of IMP studies including a protocol (in this case called a clinical investigation plan or CIP), an investigator brochure, CRFs, informed consent, monitoring plan and adverse events are described in this document. Just as for IMP studies, audits for IMD studies may be conducted by the sponsor or third parties designated by the sponsor to evaluate compliance with the CIP, written procedures, ISO 14155 and the applicable regulatory requirements. These audits may cover all involved parties, systems and facilities and are independent of, and separate from, routine monitoring or quality control functions and emphasise the need for companies to develop robust quality management systems to support IMD studies.