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BSI Blog

Welcome to the BSI Blog.

Read all that our experts have to say in our latest blogs below or navigate straight to your chosen topic using the topics sidebar.

Welcome to the BSI Blog.

Read all that our experts have to say in our latest blogs below or navigate straight to your chosen topic using the topics sidebar.

How does the IVDR impact risk classification?

The new IVDR aligns the regulatory approach for IVD medical devices with that of the medical devices in general by establishing a set of risk-based classification rules. The new rules are largely based on original work done by the Global Harmonization Task Force.

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3D printing and medical device regulation

In many cases, 3D printed devices are designed around the needs of a specific patient, and these are considered ‘custom-made’. The MDR, however, changes the definition of custom-made devices.

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Does your person responsible for regulatory compliance meet the required criteria?

Article 15 of both the Medical Device Regulations and the In Vitro Medical Device (IVD) Regulations have requirements for appointing a ‘person responsible for regulatory compliance’ (PRRC). Manufacturers and Authorised Representatives (AR) for both medical devices and IVDs have to identify at least one PRRC.

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Bioprinting and medical devices

Bioprinting techniques first emerged in 2003 with the first demonstrations of cell printing. Bioprinting offers a potentially attractive route to biological enhancement of medical devices.

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Clinical performance studies using specimens from human subjects

ISO 20916 - In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice - was published in May 2019. It is the first edition of a standard on this subject.

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Biomedical applications of 3D printing pt. 2

This week's blog post is the second part in a two part series on the biomedical applications of 3D printing. The post briefly outlines the use of 3D printing in the manufacture of dental devices, hearing aids, orthotics and prosthetics.

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Biomedical applications of 3D printing pt.1

3D printing has a number of major commercial application areas within the biomedical sphere, including surgical guides, musculoskeletal implants, hearing aids and orthotics. This week's blog post explores the use of 3D printing in the production of surgical guides.

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ISO 19650 – Things to consider when implementing it in your business

As the world’s population continues to grow and urbanisation is rapidly increasing, most countries are facing challenges in meeting the needs of their populations, including housing, transportation, energy systems, health care systems, education systems and other infrastructure.

So how does ISO 19650 support this? 

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Risk management: From the Directives to the new ISO 14971

Medical device risk management requirements have undergone significant change since the publication of the European Directives. Read this blog post for a recent history of medical device risk management.

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Glazing Summit 2019

BSI were recently invited to the Glazing Summit to take part in the debate entitled “regulations, accreditations and rogue traders” and our Technical Development Manager, Mark Barsby joined a panel of 3 experts from Fenestrology and The Glass and Glazing Federation.

Glazing Summit 2019

How is AI impacting device or system design?

AI and machine learning technologies are being adopted across a broad range of sectors, including the medical devices sector. A key attraction of machine learning is continual improvement: as more data becomes available to train a modern machine learning system, the performance of the system – in terms of accuracy – gets better.

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Production, post-production and the new ISO 14971

The clause on production and post-production information has undergone considerable modification in the third edition of ISO 14971. The principles of collecting and reviewing information have not changed, but the requirements and the activities are described more elaborately and more precisely.

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Reuse of single-use medical devices in the European Union

The draft Implementing Regulation containing the Common Specification – Single-use medical devices – safety and performance requirements for reprocessing – was made available for comment on 23 July 2019. This period ended on 20 August 2019. The draft indicates that the regulation enters into force 20 days after publication of the final text and that it applies from 26 May 2020.

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Want to learn more about gas extinguishing fixed firefighting systems?

A new tracked changes version of the European standard on gas extinguishing systems has just been published. This blog post looks at what’s covered and what’s changed since the last version of the standard in 2008.

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Get more from the European standard on fire classification of construction products and building elements

BSI has just published a tracked changes version of part one of the European standards on classifying how construction products react to fire. What does that mean for users? This blog post explains.

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Need to improve personal data security? Then extend an existing ISMS

BSI has just published a brand new standard adding personal information management to the well-established information security standard, BS EN ISO/IEC 27001. This blog post introduces the new standard and explains the thinking behind it. 

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Helping users get metallic hardness testing right

BSI has just published a tracked changes version of the international standard on verification and calibration of Brinell hardness testing machines. In this blog post we look at the standard in more detail and particularly at what’s new. 

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BSI's use of Entropy

As a multinational matrix organization, we need to track incidents and complaints like anyone else. In order to increase the visibility and reduce the paperwork of this, BSI uses Entropy Software. To find out more about BSI’s use of Entropy and how this works for us, I sat down with Andrea Cardenas, our Entropy project leader.

BSI's use of Entropy

Overall residual risk and the new ISO 14971

Once all individual risks have been controlled and judged acceptable in the risk management process described in ISO 14971, it is important to also consider the contributions of all risks together. Read this blog post for a discussion of key changes to overall residual risk evaluation in the third edition of ISO 14971.

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Harmonization of standards under the regulations for medical devices moves forward slowly

The European MDR and IVDR have specific roles for harmonized standards in demonstrating conformity. In order for a standard to be harmonized under the regulations, a standardization request has to be agreed between the European Commission and the European Standards organizations. The draft of this standardization request has now been published by the European Commission.

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Authorized representative concerns - deadline 2020

If you are a non-European manufacturer with medical devices on the European market, you will have already an authorized representative (AR) in the European Union (EU). The moment you claim compliance with the new European regulation on medical devices (2017/745 - MDR), your existing AR may become instantly obsolete. It would then be illegal to place your devices on the EU market.

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The third edition of ISO 14971 and its relation to other standards

The second edition of ISO 14971 was published in 2007 and the third edition is expected in 2019. ISO 14971 provides a generic process for risk management of all kinds of medical devices. Due to its generic character, this standard needs to be applied in combination with other process standards and device-specific standards in order to ensure the safety of the medical device and to demonstrate compliance with all regulatory requirements.

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How our new energy retrofit PDF will help improve energy efficiency

BSI recently published a combined PDF containing two PASs on retrofitting dwellings for improved energy efficiency. This blog post explains where this new document fits in and looks at how it will help installers create more energy efficient homes.

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Medical device risk management by ISO 14971: Top management

The third edition of medical devices risk management standard ISO 14971 will be published in 2019. There will be a transitional period of three years following publication to allow all stakeholders to adapt to the requirements in the new edition. The commitment of top management is indispensable for proper risk management. Large corporations can consist of separate entities (such as divisions or business units), where each entity can have its own risk management process and its own quality management system. In such cases, top management refers to those individuals who direct and control that entity.

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Medical device risk management standard completes formal vote

ISO 14971:2007 - Medical devices - Application of risk management to medical devices - is a critical horizontal standard supporting the regulation of medical devices. It was decided in late 2016 that the international standard ISO 14971:2007 would be revised. The revision process has now completed all its comment and ballot stages.

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Does a skills shortage pose a threat to organizations' resilience?

The term ‘skills shortage’ is often used in the media as a potential threat to not only industries but entire countries. In the UK, it is most often used in relation to the construction and healthcare industries. However, at an organizational level, can a skills shortage really threaten and cause issues to the same extent that traditional threats such as cyber attacks or financial management can?

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MDCG documents

This week’s Compliance Navigator blog post is the final video excerpt from a presentation delivered by BSI’s Peter Bowness at the 2019 Med-Tech Innovation Expo. The excerpt touches on Medical Device Coordination Group (MDCG) documents on MDR Article 54 and the registration of legacy devices in EUDAMED, amongst other things.

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QMS for IVDs: UDI and Vigilance

One new element in the IVDR is the implementation of Unique Device Identification (UDI) for the EU. The UDI rule implemented by the IVDR is substantially similar to the US rule, but there are several differences which will require manufacturers who already have a system in place to make some modifications to their rules.

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What organizations should be doing now in response to climate change

A growing number of organizations are now actively planning for the impacts of climate change. In response, a new British standard is providing an approach to climate change adaptation. this blog post examines what it has to say.

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MDR and IVDR – Key changes

See BSI’s Peter Bowness, Technical Team Manager from the Medicinal and Biologics Team, discuss the new EU regulatory regime for medical devices.

Watch video

Why the liquid fuel heating standard was overhauled to reflect today’s environmental concerns

The burning of liquid fuels for heating has become an environmentally sensitive issue. As a result changes have been made to one of the core guidance standards in this area, as this blog post explains.

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Global harmonization, its work items and clinical evaluation

The International Medical Device Regulators Forum (IMDRF) is a voluntary group of worldwide medical device regulators working with the aim of accelerating international medical device regulatory harmonization. IMDRF was formed in 2011, replacing the Global Harmonization Task Force (GHTF), which had its first meeting in 1993, formed to foster the global harmonization of medical device regulation. During its years of operation, GHTF issued numerous guidance documents covering medical device premarket evaluation, post-market surveillance and vigilance, quality systems, auditing and clinical studies.

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AI: incorporation into medical devices and regulatory developments

There are several drivers for the incorporation of AI into medical devices. In areas where the quantity or complexity of data is high assistance to a human interpreter can be provided by systems that can suggest diagnoses, or can retrieve cases which are in some sense, similar. This can support differential diagnosis, particularly for rare forms of some disorder; it is more than simply a retrieval system, as the criteria for matching is likely to be quite difficult to construct.

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How is AI being used in medicine and healthcare?

Virtually all active diagnostic devices that use software to interpret sensor data could be expected to benefit from incorporating AI into their controlling software. Devices that are deemed to be “good enough” might, of course, not need to be improved. But in principle, devices that can capture and make use of more information about a patient’s immediate physiological state, or emerging response to treatment, might be expected to yield better patient outcomes.

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Can systems based on AI be certified for medical use?

The answer to this question needs to consider the types of algorithm that are used in the AI system. Devices that make use of sensor data that is captured from patients might be expected to have input/output mappings that are very well defined. However, as the number of sensor measurements increases, or the history over which a signal is analysed (i.e. time-scale), there is arguably an increased possibility of unexpected device behaviour.

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Performance evaluation, post-market surveillance and the IVDR

Performance evaluation, in accordance with Article 56 and Annex XIII, including the new post-market performance follow-up (PMPF) plan must be defined within the QMS. This is an area that will have variation based on the classification of the device and should be adapted accordingly.

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Developments in quality management systems for medical devices

Updates on the use of ISO 13485 in the US regulatory scheme, the systematic review of the standard and its harmonization in Europe under the regulations for medical devices and IVDs.

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Machine Learning in the Medical Devices Sector

Clearly, a system whose behaviour is impossible to guarantee seems unsatisfactory from a safety or regulatory perspective. Why should we opt for an approach that uses machine learning (ML) — an important form of artificial intelligence (AI) — in which an artificial neural network learns its own rules for diagnosis or control, rather than one that is carefully engineered to specification?

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What’s new about IEC 60079-15 on explosive atmospheres?

One of the IEC’s most popular explosive atmospheres standards has just undergone a full technical revision. This blog post explains what’s new about the standard.

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Why city resilience is the next big business continuity standard

Resilience has become a much more pressing concern in recent years, hence a new British Standard on city resilience being launched this month. This blog post examines why this standard has become the next important step in business continuity.

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Project management is definitely not for dummies

BSI’s first true project management standards were published in 2000, since when they’ve been updated regularly. This blog post focuses on the latest revisions to BS 6079 in what is a notoriously challenging area of management.

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Should Organizational Resilience be seen as a defensive or progressive strategy?

With a growing understanding of Organization Resilience amongst the business community, we look into whether it should be seen as a defensive or progressive approach for future planning.

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Preliminary Guidelines on Phthalates in Medical Devices

In mid-March of this year, the European Commission issued a public consultation on phthalates in medical devices. If your company markets or intends to market in Europe a medical device containing phthalates, you may already be aware of this consultation; if not, you need to be aware of it.

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Managing biorisk

ISO 35001, which is under development, focuses on management of biorisks, namely the management of risks that organizations confront when handling biological agents and toxins.

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Aligning international and European standards on packaging for terminally-sterilized medical devices

The EN 868 series of European standards on packaging for terminally-sterilized medical devices has been revised. One of the intentions of the revisions of these standards was to increase the link with EN ISO 11607-1. In particular removing duplication and overlap and aligning with EN ISO 11607 in regards to general principles; terms and definitions; and information on precision and bias, repeatability and reproducibility for test methods.

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Risk management in medical laboratories

The credibility of medical laboratories is paramount to the health and safety of the patients relying on the testing services provided by these labs. ISO 22367 (in development) deals with the reduction of error in medical laboratories through risk management and continual improvement.

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International conference focuses on regulations and standards for medical technology

AAMI, the US FDA and BSI are hosting an international conference on medical devices standards and regulation. The conference is a unique opportunity to get the latest information on important regulatory developments. It links these developments to the international standards that are being prepared to support regulatory requirements.

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