I have just attended the annual TOPRA symposium on Medical Devices and technology regulatory affairs in Berlin, which brought together representatives of industry, notified bodies and regulatory authorities (including the MHRA) to discuss and understand today’s regulatory requirements, and debate the future plans for regulation. The agenda went far beyond the basics and provided an ideal platform for significantly improving our knowledge on the issues that matter, as well as offering extensive networking opportunities with new colleagues. OCTRU have a copy of the slides used during the symposium, and will be looking at our own policies to ensure we stay compliant with the regulations.
• Drug-Device Combination Products – Regulatory challenges and importance of usability and human factors considerations
• The New EU Device Regulations – Impact on Notified Bodies and industry
• Software as a medical device
• Clinical evaluations and clinical investigations
SESSION 1: The new EU Device Regulations – Impact on Notified Bodies and Industry
This session covered the revision of the EU Medical Device Directives. It provided an overview of the future regulatory framework, discussed the key changes proposed in the regulations and examined the consequences of these changes and the impact they will have on notified bodies and companies/organisations working with these products. The new Regulations are likely to be published in May 2016.
SESSION 2: Drug-Device Combination Products – regulatory challenges and the importance of usability and human factors considerations
This session covered the regulation of combination products as medical devices or medicinal products depending on principal mode of action and presentation. It discussed pertinent regulations, eg, reference to Annex 1 of the Medical Device Directive and possible changes due to the revision. The session also outlined some of the regulatory challenges facing those developing combination products and the importance of human factors and usability testing to reduce user error.
SESSION 3: Software as a Medical Device
The session looked at the regulatory challenges posed by the rapid development and deployment of advanced healthcare software. The potential gains for clinicians and patients are alluring but real dangers exist in placing over-reliance on software which may have dubious providence. Apps, cloud-deployment, cyber-security, ergonomics and network integration pose numerous regulatory dilemmas in controlling products without stifling innovation.
SESSION 4: Vigilance
This session covered the use of different vigilance instruments and projects with respect to their further development and use. We heard from leading competent authorities in Europe on how their vigilance system is running, what challenges are to be dealt with and what European projects with respect to vigilance are on the horizon on the way to the new medical devices ordinance.
SESSION 5: Clinical Evaluations and Clinical Investigations
Clinical Evidence is a prerequisite to the marketing of any medical device. The results of a well-conducted clinical evaluation (literature review) and or a Clinical Investigation is a key part of obtaining regulatory approvals for medical devices on a global basis. A clinical evaluation should be conducted for all medical devices for CE marking unless there is due justification and the clinical data requirements can be met by other means. Where sufficient clinical data is not available or in cases of high risk devices a clinical investigation may be necessary. This session provided different perspectives on the clinical evaluation from a notified body and industry viewpoint.