Medical Device Resources

After a medical device is CE marked, the manufacturer is required to set-up, implement, and maintain a Post-Market Surveillance (PMS) System and carry out PMS activities over the whole life cycle of a medical device, as defined in European Medical Device Regulation 2017/745 (EU-MDR) Article 2 (60), with requirements as per Chapter VII Section I, Articles 83 through 86. Detailed requirements for a PMS System are given in Article 83.3. Further guidance is given in PD CEN ISO/TR 20416:2020, Medical devices — Postmarket surveillance for manufacturers, which aligns the PMS process with BS EN ISO 13485:2016+A11:2021, Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes, and BS EN ISO 14971:2019+A11:2021, Medical devices — Application of risk management to medical devices.

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Machine Learning for Medical Devices (MLMD) has created a level of excitement not seen since the discovery of stem cells over 60 years ago. There are similarities between the excitement generated by the discovery of stem cells and Artificial Intelligence / Machine Learning and its use in medical devices.

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A medical device can only be placed on the European market once the manufacturer declares conformity of the device with applicable EU Regulations. Manufacturers provide evidence for conformity with the applicable regulations with a set of documents that describe comprehensively the medical device, including, among many other aspects, the intended purpose, design, manufacturing, verification and its validation. This set of documentation is called Technical Documentation (TD). The expected content of a TD is set out in the Annexes II and III of Medical Device Regulations EU 2017/745 (MDR)1 and EU 2017/746 (IVDR).

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The European database on medical devices (EUDAMED) is an Information Technology system being built and implemented by the European Commission (EC) to fulfill 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 transparency of the regulatory system for the public and healthcare professionals.

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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. Since the publication of the legal texts, there have been corrigenda issued. The changes in dates are in response to the challenges created or exacerbated by the COVID-19 pandemic impacting on manufacturers’ ability to undergo conformity assessment of technical documentation.

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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.

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Artificial Intelligence (AI) is a fast-growing field. This is evidenced by the number of global publications, more than 334K in 2021 (Daniel Zhang, 2022), and the number of global AI patents, estimated above 142K in 2021 (Daniel Zhang, 2022).

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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. This is certainly not a new requirement for companies. Philip B. Crosby said “Quality Management is a systematic way of guaranteeing that organized activities happen the way that they are planned… Quality management is needed because nothing is simple anymore, if indeed it ever was.” Although this quote is now nearly 40 years old, it is as true today as it was then. Companies still need a system in place to ensure that activities happen according to plans, especially as the environment continues to get more complicated with increasing regulation, customer expectations and product complexity.

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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.

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This white paper is built around a table that seeks to provide a checklist for IVDR preparation, based on the requirements of EU Regulation 2017/746.

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Performance evaluation is a critical part of verification and validation of product performance that is recorded in the supporting technical documentation required to place an in vitro diagnostic device (IVD) on the EU market.

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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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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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There has been significant evolution in the European regulatory landscape over the past 10–15 years, particularly with respect to requirements for clinical evaluation. These changes have been driven in part by a series of medical device failures, which fuelled a perception, particularly amongst regulators and clinicians, that clinical evidence for medical devices was not receiving sufficient scrutiny in Europe.

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This white paper explains the purpose and contextual background of the Summary of Safety and Clinical Performance (SSCP) and summarizes the key requirements and recommendations from the MDR and MDCG 2019-9 guidance.

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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 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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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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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. Download this whitepaper for an overview of the requirements of MDR/IVDR Article 15.

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A medical device can only be placed on the European market once the manufacturer declares conformity of the device with applicable EU Regulations. Manufacturers provide evidence for conformity with the applicable regulations with a set of documents that describe comprehensively the medical device, including, among many other aspects, the intended purpose, design, manufacturing, verification and its validation. This set of documentation is called Technical Documentation (TD). The expected content of a TD is set out in the Annexes II and III of Medical Device Regulations EU 2017/745 (MDR)1 and EU 2017/746 (IVDR).

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The International Medical Device Regulators Forum (IMDRF) aims to accelerate international medical device regulatory convergence.​Through the IMDRF, regulators reached consensus on what software is considered a medical device. Regulators call it ‘software as a medical device’ (SaMD). This paper provides a comparison of how SaMD is regulated in the US and in the EU.

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