Whitepapers

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.

EUDAMED: an overview of how it is being developed and deployed by the European Commission

The European database on medical devices (EUDAMED) is an Information Technology system being built and implemented by the European Commission (EC) to fulfil many of the obligations of the Medical Device Regulation (MDR — EU 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR – EU 2017/746), referred to in this white paper as the “Regulations”. It is a cornerstone of both Regulations and is intended to provide a living picture of the lifecycle of medical devices and in vitro diagnostic medical devices (IVDs) on the Union market. It integrates six separate and distinct electronic systems (referred to in this white paper as “modules”) that collate and process information related to Actor Registration, UDI & Device Registration, Notified Bodies and Certificates, Clinical Investigation/Performance Studies, Vigilance/Post-market Surveillance and Market Surveillance. Certain information will be publicly accessible via the EUDAMED public site, which will enhance the transparency of the regulatory system for the public and healthcare professionals.

The European Medical Devices regulations: What are the requirements for vigilance reporting and post-market surveillance?

The European Union (EU) Medical Devices Regulation1 (EU 2017/745) (MDR) and the In Vitro Diagnostic Medical Devices Regulation2 (EU 2017/746) (IVDR), now apply. Important terms used in the regulations are ‘entry into force’ and ‘date of application’. The publication of the text in the Official Journal of the European Union was on 5 April 2017. The ‘entry into force’ was the date when each regulation came into effect, twenty days after publication. The ‘date of application’ reflects the date from which the requirements apply and the Active Implantable Medical Devices Directive (AIMDD – 90/385/EEC), Medical Devices Directive (MDD – 93/42/EEC) and In Vitro Diagnostic Medical Devices Directive (IVDD - 98/79/EC) were repealed.

The Differences and Similarities between ISO 9001:2015 and ISO 13485:2016

Both ISO 9001:2015 and ISO 13485:2016 have gone through their first standard review period to be reconfirmed for another 5-year period. These two standards for Quality Management Systems (QMS) have different structures and differences in the definition of risk and other terms. In this paper, we are looking to see how these standards co-exist and what developments are being discussed. The intent of this document is to provide insight into some of the differences and similarities between the standards, to allow organizations to understand how they can continue to work together for organizations that are part of the medical device supply chain, without undue burden to their systems.

Developing and maintaining a quality management system for IVDs

There are many different requirements with which in vitro diagnostic manufacturers have to comply in order to place products on the market. At the core of most of these requirements is a fundamental need to have a good quality management system (QMS) in place. There are several regulations and standards that focus on QMS requirements, but this paper primarily examines the QMS requirements in the new In Vitro Diagnostic Device Regulation (IVDR) 2017/7462 which has entered into force as of 26 May 2017 and will serve as the basis for access to the European market. Complying with the requirements of BS EN ISO 13485:2016 will largely fulfil those requirements established in the IVDR.

Implementing the EU Medical Devices Regulations

The European Union (EU) Medical Devices Regulation (EU 2017/745) (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU 2017/746) (IVDR), now apply. Important terms used in the regulations are ‘entry into force’ and ‘date of application’. The publication of the text in the Official Journal of the European Union was on 5 April 2017. The ‘entry into force’ was the date when each regulation came into effect, twenty days after publication. The ‘date of application’ reflects the date from which the requirements apply and the Active Implantable Medical Devices Directive (AIMDD - 90/385/EEC), Medical Devices Directive (MDD - 93/42/EEC) and In Vitro Diagnostic Medical Devices Directive (IVDD - 98/79/EC) were repealed.

EU MDR and IVDR: unique device identification

The convergence of the pharmaceutical and medical devices industries

Person responsible for regulatory compliance (PRRC) - MDR/IVDR Article 15

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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A notified body’s perspective on the clinical evaluation requirements under the MDR

EU MDR and IVDR: unique device identification

Phthalates and endocrine disruptors

The convergence of the pharmaceutical and medical devices industries

Person responsible for regulatory compliance (PRRC) - MDR/IVDR Article 15