Whitepapers and articles

Download the latest medical device whitepapers and articles below to help you perform better, reduce risk and make excellence a habit in your organization.

Recent whitepapers

Using standards to demonstrate conformity

Using standards to demonstrate conformity

The application of standards in the medical devices sector has undoubtedly been accelerated by their use to support regulation by providing a voluntary means to demonstrate conformity with regulatory requirements.

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Medical device clinical investigations

Medical device clinical investigations — What’s new under the MDR?

This paper was first published by BSI in 2018 and has been revised in light of the publication of BS EN ISO 14155:2020. The paper discusses important requirements for pre-market and post-market clinical investigations under the European Medical Device Regulation (2017/745) (MDR), relevant European guidance documents and BS EN ISO 14155:2020, and how this updated standard can help in meeting MDR requirements.

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Journal MDR logo

A notified body’s perspective on the clinical evaluation requirements under the Medical Device Regulation

Understanding of the clinical evaluation process for medical devices against the requirements of the MDR, relevant Medical Device Coordination Group guidance documents is critical for all manufacturers.

Hear from BSI’s Richard Holborow, Head of Clinical Compliance in his recent article in the Journal of Medical Device Regulation on the requirements for clinical evaluation under the MDR from a Notified Body’s perspective and how to meet those requirements.

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EU MDR and IVDR: unique device identification

EU MDR and IVDR: unique device identification

This white paper provides an overview of the EU UDI system, its requirements and the status of EUDAMED, along with some practical recommendations for manufacturers to support their UDI system compliance efforts.

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Phthalates

Phthalates and endocrine disruptors

Phthalates are plasticizers that impart flexibility to plastic products and can leach into their surroundings. Many phthalates have the potential to cause hormonal disruption. This white paper summarizes the evaluation of phthalates and endocrine-disrupting (ED) substances in medical devices (MDs).

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The convergence of the pharmaceutical and medical devices industries

The convergence of the pharmaceutical and medical devices industries

Find out more about the different categories of combination products within the EU along with the regulatory pathways designed to ensure they are safe and perform as intended.

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PPRC Whitepaper cover, person using computer

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

With the MDR and IVDR, European regulators aim to ensure companies have a regulatory expert – a Person Responsible for Regulatory Compliance (PRRC) – at their disposal, to ensure that the company is meeting certain specific EU requirements.

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View all whitepapers

Click on the titles below to read more about each whitepaper.

  • Authorized representatives under the MDR >
    Learn about the background to the new EU rules regarding authorized representatives and the actions your organization may need to take as a result of them with our dedicated guide.

  • Classification changes under the MDR >
    Download our guide to the risk classification rules under the MDR and gain expert insight into the background to the new EU rules regarding risk classification and the actions your organization may need to take as a result of them.

  • Comparison of the articles of the European MDD and the MDR >
    This guide presents a summary of the provisions of some of the articles of the MDD and MDR together with commentary providing discussion and highlighting the key differences.

  • 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.

  • Digital maturity in an age of digital excitement >
    Digital technology in the medical devices sector has the power to excite. But, it is important that a mature, critical approach is taken when evaluating new technologies. Download this medical device white paper today and learn about digital maturity.

  • Effective post-market surveillance >
    This paper explores the current regulatory and legislative requirements with regards to post-market surveillance (PMS), in the wake of recent health scares concerning implants.

  • Engaging stakeholders in the home medical device market >
    This paper considers the implications for manufacturers when medical devices designed for trained professionals move to community use and looks at essential issues for designing devices specifically for this growing market.

  • General Safety and Performance Requirements (Annex I) >
    This paper provides comparison of the Safety and Performance Requirements (SPRs) of the new Medical Devices Regulation (MDR) and the Essential Requirements (ERs) of the Medical Devices and Active Implantable Devices Directives that they replace.

  • Importers, distributors and assemblers >
    Download our guide and gain expert insight into the background to the rules regarding importers and distributors under the MDR/IVDR and the actions your organization may need to take as a result.

  • ISO 13485 - The proposed changes and what they mean for you >
    This paper introduces the proposed updates to ISO 13485, the quality management system standard that complements product specific directives.

  • Nanomaterials >
    This white paper discusses the advent and use of nanomaterials in medical devices and explores the regulatory requirements for devices containing nanomaterials.

  • Negotiating the Innovation and Regulatory Conundrum >
    This paper raises important questions about the attitude to creative product development, illustrating the need for a closely documented approach throughout the process.

  • Planning for implementation of the European Union Medical Devices Regulations >
    This paper discusses decisions that need to be made by affected organizations and includes questions to ask about your organization’s preparedness in order to comply with the new requirements.

  • Post-market surveillance under the MDR/IVDR >
    Gain expert insight into the background to the new EU rules regarding post-market surveillance (PMS) and the actions your organization may need to take as a result of them.

  • Recent advancements in AI – implications for medical device technology and certification >
    The purpose of this white paper is to provide a very brief overview of where AI is being used in healthcare, and why it might be increasingly seen in medical devices.

  • 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 to support those working with these aspects within the MDSAP Program.

  • Risk Management for Medical Devices and the new ISO 14971 >
    This whitepaper seeks to provide a brief overview of the development of risk management from elementary risk awareness in the early days to the structured stepwise process of planning, assessment, control and monitoring that we have today.

  • Technical Documentation and Medical Device Regulation >
    This whitepaper reviews the regulatory requirements for Technical Documentation under the new MDR, with focus on conformity assessment routes and post-market surveillance.

  • The differences and similarities between ISO 9001:2015 and ISO 13485:2016 >
    Quality management professionals need to know the differences and similarities in these two revised standards in order to react to the revisions and mitigate any concerns the revisions may create.

  • The European Medical Devices Regulations >
    This paper addresses a number of areas, including PMS as an element of the management of clinical evidence throughout the device lifecycle, the PMS system, the PMS plan; preparation of a summary report of PMS information, complaint handling and more.

  • The growing role of human factors and usability engineering for medical devices >
    By applying knowledge of human capabilities and limitations Human Factors and Usability Engineering (HF/UE) contributes to the design of intuitive displays, controls, and other interfaces that substantially reduce the risk of user error.

  • The impact and potential for 3D printing and bioprinting in the medical devices industry >
    This whitepaper seeks to review the history of 3D printing of medical devices, identify the key characteristics of successful exploitation, and to examine the scope for bioprinting processes to enhance medical devices.

  • The post-market priority >
    Dr. Hamish Forster, BSI orthopaedic and dental product expert, provides an overview of the key elements required within technical documentation to demonstrate conformity to the Medical Device Directive 93/42/EEC.

  • The role of the person responsible for regulatory compliance >
    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.

  • UDI and the MDR/IVDR >
    Download our guide and gain expert insight into the background to the new EU rules relating to unique device identification (UDI) and the actions your organization may need to take as a result of them.

  • What you need to know about the FDA’s UDI system final rule >
    Taking an in-depth look to explore standardized granular identification of medical devices, associated meta-data to support various public-health initiatives and step by step guidance and advice for UDI compliance.