Tag Archives: EU

Updated – fifteen things you need to know about the Medical Device Regulation

Update: Since we first published the 15 things, the Medical Device Regulation has moved on apace:

  • The MDR was approved by the European Parliament on 5 April 2017
  • The MDR was published in the Official Journal of the EU on 5 May 2017 and came into force on 25 May 2017

While the detailed MDR text is of interest to people working within regulatory affairs, everyone else probably wants to find out “what does it mean for me?”

So, here are 15 things you need to know about the MDR:

Thing 1.

You will need to consider how your device / technology / combination product is managed throughout it’s life-cycle, as the MDR proposes a broader focus than the pre-approval view taken by the Medical Devices Directive. This means that you will have to follow up on quality, performance and safety of devices after they are placed on the market

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Catching up with the Pharmaceutical regulations, where the role of the Qualified Person has been required for some years, you’ll be required to have a “responsible person” within your organisation, to safeguard regulatory compliance

Thing 3.

Unique Device Identifiers will be introduced, similar to the system in place for the US market

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The role of your Notified Body will evolve from being an industry “helper” to an extension of competent authorities’ market surveillance apparatus. They will have to complete a rigorous application process before re-achieving Notified Body status and will be monitored for both competence and ethical operation

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You will be subject to unannounced audits from your Notified Body at least every 5 years. These audits will cover not just the medical device manufacturer, but also their suppliers and sub-contractors

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You’ll have two Regulations to comply with, instead of 3 Directives (let alone the 28 different pieces of national legislation to enact them in member states) and at least 4 guidances (MEDDEVs)

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A higher bar for clinical data looks likely for lower risk medical devices, equivalence won’t be commonly available as a route to demonstrate clinical safety or performance. For implantable and Class III devices, clinical investigations are likely to be the norm

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You’ll have a specific regulatory body to deal with for expert review of your submissions for higher risk devices, the Medical Device Coordination Group

Thing 9.

Those products you have classified as “accessories” at the moment will become medical devices, if they’re used with cleaning, disinfection or sterilisation medical devices

Thing 10.

Devices like coloured cosmetic contact lenses, without a medical purpose but with characteristics similar to medical devices, will fall within the scope of MDR

Thing 11.

Should you be in the unfortunate position where injured patients or their representatives are seeking compensation for a defective medical device, the technical documentation you produced to demonstrate conformity can be shared by authorities with patients or their representatives

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If you aren’t already, you will be required to use a Quality Management system

Thing 13.

The Essential Requirements have grown, so you’ll probably want to review and update your Essential Requirements checklist

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Medical devices look likely to be labelled as such, similarly to that already required for an In-vitro Diagnostic device. This could lead to a new “MD” symbol being defined

Thing 15.

You have some time to get ready, even though the Regulation is now law in the EU. It is probably a good idea to become familiar with the changes so you’re not playing catch up with your competitors and the regulators.

  • The MDR and IVDR were approved by the European Parliament on 5 April 2017
  • The MDR and IVDR were published in the Official Journal of the EU on 5 May 2017 and came into force on 25 May 2017
  • There’s a transition period of three years for the MDR, so until May 2020.  Compliance with the MDR becomes mandatory.
  • Similarly, for the IVDR, there’s a five year transition period until May 2022.

What next?

Now that you’ve read the 15 things you need to know, you may find it helpful to talk with someone about what you’ll be doing differently for your upcoming projects, existing processes and quality systems.

Give us a call or send an email to start the discussion,

15 things you need to know about MHRA Human Factors expectations

We now have official guidance for Human Factors and Usability Engineering in a member state of the EU.

19th September 2017 saw publication of official guidance from MHRA (the UK medicines and medical devices regulator) for Human Factors and Usability Engineering for medical devices and drug-device combination products. You may recall that the agency published a draft document for consultation in mid 2016. The final document extends to 47 pages and includes many changes as a result of consultation responses.

While of detailed interest to people working within human factors, everyone else probably wants to find out “what does it mean for me?

So, here are 15 things you need to know about the MHRA guidance:
Thing 1.

MHRA’s newly released final guidance emphasises its applicability to all classes of medical devices and device-drug combination products, there’s absolutely no avoiding usability engineering.

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Content of the guidance appears closely aligned with FDA guidance and international standards, with some useful additional information to that discussed by FDA.

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MHRA provide a great tool for anyone making the case for usability activities within their organisation; the guidance spells out exactly the essential requirements in the Medical Devices Regulation (MDR) and In-Vitro Diagnostic medical devices Regulation (IVDR) that mandate usability activities, along with a helpful annex mapping the MDD and IVD to the new regulations.

These breadcrumbs will also help manufacturers who are working to prepare their devices for the end of the MDR and IVDR transition periods.

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Clearing the once muddy waters surrounding drug-device combination products, MHRA establishes that the Essential Requirements enshrined in the MDR and IVDR are equally applicable to the device components of drug-device combination products.

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The document provides a helpful compendium of regulations, standards and guidances that should be referred to for development. The information can be seen as a signpost for those just venturing in to this arena, and serves as a reminder for the seasoned manufacturer.

Thing 6.

MHRA appear to have adopted a more realistic approach to the guidance on risk analysis, pulling back from the previous stance of expecting documentation of all possible use errors to a more realistic approach of capturing “reasonably foreseeable” use errors. This sits well with FDA expectations. A gift for usability professionals battling to influence sensible and design oriented risk management, MHRA have included an expectation of a rationale for the prioritisation of risk mitigations, often overlooked by development teams.

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Thankfully, the finalised guidance requires the development of a user interface specification and a usability plan at an early stage in development, aiding the inclusion of usability activities within project timelines, resourcing and budgeting, rather than as a last minute “add-on”.

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The value of formative usability studies is enhanced by closing the loop from risk analysis informing formative study design through to feeding back into the risk analysis the results of a formative test (unforeseen use errors, occurrence levels, etc.).

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Rightly, there’s now heavy emphasis on the ethics dimension of formative testing and manufacturers responsibility to ensure appropriate ethical consideration is given to the design and execution of formative and summative studies.

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Summative testing (called validation by FDA) now explicitly includes training that may be needed, and sets the realistic expectation for inclusion of users who are unfamiliar with the particular device.

Thing 11.

The HF Summary Report, whilst a very useful document to describe the usability journey, does not achieve all FDA expectations (in particular a greater focus on risk), so manufacturers will need to determine how best to fulfil both sets of guidance, if they intend to market their device(s) in both the EU and US.

Thing 12.

Helpfully, the section on Post Market Surveillance identifies some potential data sources, that will help manufacturers get more out of these activities for both existing products and future development projects.

Thing 13.

Guidance is now given about what to do for older products, of particular relevance as their manufacturers gear up to ensuring compliance with the MDR in the near future.

Thing 14.

The whole topic of simulation, which previously gave rise to concern amongst manufacturers, has now been removed from the guidance. Instead, the reader is pointed towards information covered in ISO 62366 (parts 1 and 2).

Thing 15.

With regard to drug/device combination products, the guidance points to changes in the MDR that require an assessment of device components with the Essential Requirements (including those related to human factors / usability). Helpfully, the MHRA document also references EU guidance relating to drug-delivery devices and specific products.
 
What next?

Now that you’ve read all 15 things, you may find it helpful to talk with someone about what you’ll be doing differently for your upcoming projects, and existing products.

Pick up the phone today, or write an email to our team right now.

Human Factors high on FDA Priorities for 2016

So, the FDA’s Center for Devices and Radiological Health (CDRH) have included Human Factors in their 10 priorities for 2016 and Regulatory Science. There have been many blog posts published summarising the 10 priorities, as they “serve to accelerate improving the safety, effectiveness, performance and quality of medical devices”.

But why the emphasis?

Why Human Factors matters

Hopefully, as you’re reading this, you’ll already be aware of why98000 Human Factors is integral to safe products. As a refresher, here’s why;

  • 80% of medical device errors are due to human error.
  • Every year, around 98,000 people die in hospitals in US, 11,859 in England, due to medical errors, many of which are due to Use Errors.

“Many device recalls and adverse event reports reflect underlying human factors engineering problems including usability issues and preventable design problems” (FDA CDRH)

Yet we spend a lot of time during development working to reduce the 20% of errors that are due to device performance, testing our devices to ensure the build quality is robust and that the performance is acceptable.

What about working to reduce the 80%?

CDRH priorities include Human Factors

Well, CDRH included Human Factors in their priorities because it helps;

  • Facilitate medical device innovation and bring new technology to market,
  • Enhance or expedite the availability of medical devices while maintaining their safety and effectiveness,
  • Facilitate rapid identification of problems.

What does all this mean for those medical devices or combination products already in development?

A great emphasis will continue to be placed upon adequate and robust Human Factors programmes during development. Programmes that clearly identify who the product is being build for and their needs, demonstrate the integration of Human Factors throughout design development and culminate in evidence that the product is safe and effective in use (i.e. a robust summative usability study).

It is perhaps not surprising that the focus for 2016 includes HF, as there’s been much dialogue between industry and regulators in recent years on this topic, including the wider implications of devices being used outside the clinical setting (see our post on that topic from January 2015).

Merging of EU and US Human Factors requirements

The playing field between EU and US requirements is being levelled (our September 2015 post discusses this in detail). For the EU, developers now need to provide the same Human Factors programme evidence as for the US. So, consequently, the focus on Human Factors will be higher in the EU too.

You may well be thinking that, if you’re developing a product for several markets, it makes sense to develop to meet US Human Factors requirements, as that will satisfy 99% of the needs of the EU and other major world markets.

What does this mean for your product?

You may be thinking about how you could best ensure your development programme meets the requirements for Human Factors.

Pick up the phone (+44 1270 61 86 93) or click on the “Get in touch” tab to the right of your screen to explore how we can help you ensure your product is “right first time”.

Further reading about Human Factors

Perhaps reading this article has left you wanting to find out more about the world of Human Factors (also known as Usability).  There are two things you can do:

1. If you’re new to HF or would appreciate a refresher, you will be interested in reading our book “How Humans Factor (in medical device design)”.  Email us to request your free e-copy.

2. Have a read of other recent posts on the topic of Human Factors:

Usability study leads to key medical device design improvements

A team from Three Circles recently completed a 2 week long formative usability study for a medical device in Europe.

The study was typical of the more complex designs we undertake, involving 2 device concepts, both of which were for use in two distinct use scenarios. Further complexity was added by there being several distinct and different target user groups, some received training, others did not. We designed the study to satisfy a wide-ranging client brief, created a detailed study protocol, and executed it using a bespoke interview facility.

“really pleased with everything, well organised and executed” – study sponsor

Each study session was between 30 and 60 minutes long.

Analysis, input to client risk management and design changes, reporting and client sign off was achieved within 2 weeks of study completion.

“we appreciated the quality and precision of the study design and reporting. We’re already making design changes based on what you found” – client

Maybe you’re looking for someone to plan, execute and report a usability study, talk to us about how we can work together to satisfy your development requirements.