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Our white papers will help you understand how to perform better, reduce risk and make excellence a habit in your organization. Please complete the fields below to access all of our medical device white papers.

Responsible persons: The role of the person responsible for regulatory compliance

The MDR and IVDR represent significant changes to European legislation for medical devices and in vitro diagnostic medical devices (IVDs). One significant new requirement is that manufacturers and authorized representatives for both medical devices and IVDs appoint at least one person responsible for regulatory compliance with responsibilities that cover the quality management system (QMS), regulatory documentation, post-market surveillance and vigilance reporting, and devices used for clinical investigation. Download our guide to learn more about the background to the EU rules regarding responsible persons and the actions your organization may need to take as a result of them.

Nanotechnology

Nanotechnology is now a mature subject in terms of the basic science, and while there were many claims for what it could achieve 20 years ago, the application to medicine and healthcare has now become more well defined. When considering nanotechnology's future in the medical devices field, it is best to divide the field into five main categories: medical image enhancement; drug delivery vehicles; nanomaterials for functional coatings; therapeutic aspects of nanomaterials that make use of their small size and properties; and finally biosensors that make use of nanoparticles. There are common themes that apply to each of these fields and in this review we will summarize these and identify gaps in understanding and opportunities.

Responsibilities for medical device vigilance reporting

This paper outlines the requirements specific to incident reporting, vigilance, mandatory problem reporting, medical device reports and adverse event reporting, herein termed ‘vigilance’, in comparison with the requirements of the recently published European Medical Device Regulation (MDR) to support those working with these aspects within the MDSAP Programme. Manufacturers who wish to supply their devices outside of these regions may have many more requirements to meet, the discussion of which is beyond the scope of this paper.

Cybersecurity of medical devices

This paper considers the cybersecurity challenges facing the healthcare sector arising from the convergence of technology, hyper-connectivity and recent developments in regulation. It explains the issues and tensions between safety and security and what can be done to resolve them. The paper highlights emerging good practice and approaches that manufacturers can take to improve medical device security throughout its lifecycle. The paper will also be of interest to others in the sector, including healthcare providers, IT suppliers, notified bodies and regulators.

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