Tag Archives: regulation

Rising cost of compliance for medical devices in Canada

Our recent insight post highlighted a key change in Health Canada’s requirements for companies seeking authorisation to market their devices.  A change that is leading to disquiet amongst manufacturers for the Canadian market.

From 1 January 2019, Health Canada will only accept manufacturer audits performed under the MDSAP programme, closing the current conformity assessment system.  Manufacturers are not expected to make the switch overnight, however.  Health Canada published specific criteria in April, for manufacturers to preserve their current ISO 13485 certification and surveillance cycles whilst transitioning to the new arrangements.

Perhaps understandably, the change is causing consternation to manufacturers of smaller volume medical devices.  Companies are reporting a ten-fold increase in audit costs as a result of the change, an increase that is likely to hit small businesses hardest, according to a recent report by Canadian national newspaper The Globe and Mail.

Whilst having a successful MDSAP audit would aid registration in other territories, the way MDSAP audits are performed may result in a more lengthy and costly process for Canadian manufacturers.  The scarcity of resources to perform the audits, and the passage of time, may exacerbate the situation.

It should be noted that the regulatory requirements remain the same in 2019, it is the method for confirming compliance that will change.  Health Canada expect adopting the MDSAP requirement will “strengthen the post-market surveillance and risk management” for medical devices.

The Globe and Mail reports Health Canada as “offering to reduce, for small companies, the time spent performing the audit” alongside giving more time to have the audit completed, as long as its scheduling is done in 2018.

It has been said that the change could bring advantages to manufacturers in the EU and US looking to market their devices in Canada – as having a successful MDSAP audit stands them in good stead for registration in multiple countries. Closure of the Canadian conformity assessment system removes a hurdle for those companies, reducing the “cost of entry” somewhat.

This situation underlines the long-term benefits of considering regulatory requirements for a range of territories when developing medical devices, instead of focusing in on requirements of the launch market.

Only time will reveal the true impact of the change, on both domestic Canadian medical device manufacturers and those looking at entry into the country’s health care market.  We will keep you posted on developments.


Riding the wave of Software as a Medical Device

For years there’s been an indistinct, blurry area, surrounding software and apps that are deemed medical devices and so called “wellness” or “lifestyle” applications. Signs of change have emerged over the past few months, in the US at least. And where the US leads, other territories will follow.

It’s probably little surprise, given that software apps rely upon a stable platform to operate effectively.

If, like us, you’ve ever experienced an update to one of the apps on your smartphone either “break” functionality or impact on how another, seemingly unconnected, app performs, then you will appreciate why this is a challenge that needs to be resolved.

FDA publishes and updates guidance documents

Signs of the changes for Software as Medical Devices (SaMD) are mainly found in the activities of the FDA (the US regulator for drugs and medical devices) and forms part of the US government’s drive to bring regulation up to date, by passing the “21st Century Cures Act” into law.

Agency guidances have since been published for a range of topics;

Clearly, FDA view the changes as important to the health of the US populace.  Taking the case of apps used to support drug treatment as just one example, here’s what the FDA commissioner, Scott Gottlieb had to say;

“Mobile devices and software linked to specific drugs can help patients stay on therapy for treatments where medication compliance is traditionally a challenge”

International guidance for software as medical devices

The flurry of activity comes on the heels of the last in a series of documents produced in the area by the IMDRF (International Medical Device Regulators Forum).

Perhaps you’re not too familiar with the work of the IMDRF? That’s ok, it is after all a rather niche topic. Regulators from the EU and 9 countries have been working together “to develop guidance that supports innovation and timely access to safe and effective Software as a Medical Device”.

Work completed by this IMDRF working group produced a suite of guidance documents relating to SaMD, including;

If you’re considering, or are already a long way down the path to, developing, pure software medical devices or “accessory” apps, such as those used to manage a chronic disease such as diabetes, then you need to be aware of the shift and adjust your approach accordingly.

Help is at hand for software as a medical device

Clearly, there’s a lot to take in with the swathe of documents, before assessing the impact the changes may have upon your development plans.

Over the coming weeks, we’ll be sharing insights for each of the documents mentioned in this article.

Subscribe (add your email to the box on the right of this page), to ensure that you’re alerted as soon as new information is published.

Perhaps you want to get to grips with the changes today?  Get in touch now.

Self-certification, what’s the Medical Device Regulation done with it?

There’s a heart stopping moment in store for manufacturers of low risk, non-invasive medical devices!

The EU Medical Device Directive contained a number of Annexes that mapped out the various routes to demonstrating Conformity with its provisions.  These ranged from the self-certification for Class I, non-measuring, non-sterile devices, through to certification of both your Quality Management System and the medical device by a Notified Body, coupled with regular surveillance visits and re-certification.

Developers and manufacturers have become accustomed to simply checking the Annexes to establish which route to Conformity made sense for their medical device and business.

Everything changes with the Medical Device Regulation?

Then, along came the Medical Device Regulation (MDR).  In case you’re not already aware, the MDR becomes effective on 25 May this year, with a 3 year transition that finishes on 25 May 2020.  Yes, there are some the major changes to the content, and closer alignment of the MDR with similar regulations for pharmaceutical products.

But, when you reach for the MDR Annexes to check Conformity for that device you have in development, you may notice that one Annex is missing!

The Annex formerly known as “Annex VII EC Declaration of Conformity” has gone!

Yep, the route for self-certification of low risk Class I devices by their manufacturers has disappeared.

What the Medical Device Regulation changes mean

We had calls from several clients recently, panicked that their low risk devices would in future need a Notified Body to certify their QMS and Technical File.  In some cases, this could sound the death knell for their device.

Fortunately, our team were ready to calm these troubled waters.  And here’s what we shared with our worried clients:

  • Yes, the previous content of Annex VII has gone from the MDR.  However, the main body of the MDR reveals the following provision in Article 52:

“7.  Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III.”

  • So, the self-certification route to Conformity still exists, for those low risk Class I, non-measuring, non-sterile medical devices.  The requirements for documentation of your Technical File and Post Market Surveillance are detailed in Annexes II and III, rather than being buried elsewhere.

The team went on to outline how the documentation will need to be structured and typical contents that our clients would be required to develop.  Naturally, we will be there to help them through this.

Perhaps you’d like to have a similar conversation with our team?  Get in touch today.


FDA Finalises Human Factors Guidance – summative testing – Part 3

In this series of posts, we’re taking a look at the recently published final version of CDRH’s guidance “Applying Human Factors and Usability Engineering to Medical Devices”.
We have already taken a look at the first three in this list of the key topics covered by the Center:

  • Human Factors Engineering processFDA HF guidance FINAL
  • Risk Management and Human Factors
  • Design Verification
  • Summative Human Factors testing
  • Changes to products already on the market
  • Human Factors Engineering Summary report

In part 3, we’ll look at how the topic of Human Factors testing (both formative and summative) may impact what you’re either already doing, or plan to do.

Formative Human Factors testing

Look upon this stage of testing as providing a toolkit to identify potential use-related hazards and hazardous situations. The agency emphasises the value of testing with participants who are representative of your intended users, as this yields early data on how your eventual users cope (or don’t) when using your prototype device.

The agency recognise that formative evaluations provide information about;

  • Design of the user interface (those parts of the device that are manipulated by the user, provide them with information or indicate function)
  • The effectiveness of features or changes implemented to reduce or eliminate use errors (otherwise known as mitigations)
  • The the need for training of users and inform the design of training materials
  • The design and content of labelling such as the Instructions For Use, product labelling, packaging.
  • The content and design of your summative testing.

In the guidance, the Center talk about the value of effective formative testing in preventing very costly errors in the design of your validation test protocol that render it just another formative study.

In a departure from previous guidance, there is information on the expected content of formative test protocols, which creates a coherent and building picture that results in the information now expected for your HF validation test protocol. It’s very much a case of using formative studies as building blocks that provide a robust foundation for your validation test.

Summative Human Factors testing

Summative testing is still in place. However, testing that demonstrates the “user requirements” or User Needs have been met will henceforth be referred to as “Human Factors Validation Testing”. One could perhaps see this as coming into line with the philosophy applied to validation of processes, test methods, production lines, etc

No longer does guidance expect you to just include critical tasks within your test design. Rather, the testing needs to be comprehensive, so that the results can be related to actual use.

Test participants

If your device is intended to treat patients with a condition that can cause them to have functional limitations, these conditions must be represented during both the formative evaluations and your HFE validation study. If you choose not to design your device to accommodate needs of those likely to use your device, then labelling should clearly explain the capabilities that users must have to use the device safely and effectively. You should, therefore, ensure that you’ve understood your Users’ needs thoroughly and scoped out the Usability Specification appropriately to know what capabilities/limitations are to be included in study participant groups.

Participant Training

If you anticipate that most users of your device would receive minimal or no training, the Center now expect that participants in your validation study do not receive training.

A period of time between training and participation in your validation study should be built in to the study design. How long that is will vary, depending upon what would happen in real life and the impact of training decay on the use-related risks that you’ve identified for your device. The important thing is to consider this topic and document your rationale for the chosen approach.

Study protocol

Manufacturers are now formally encouraged to submit draft HF Validation Test protocols for agency review, to ensure that the methods you plan to use are acceptable (via the pre-submission programme). We’ve been fortunate to have supported several clients in developing and submitting draft protocols to CDRH, so have benefited from a “heads up” about many of the changes that are now embodied in this final guidance document. The review can be a great way to confirm that your approach to HF Validation will satisfy expectations.

If testing of labelling formed part of the validation study, the agency now require this to be conducted separately after simulated use testing.

The test protocol must provide a rationale for the extent of device use and the number of times that participants will use the device. This means frequency of device use must be considered; for devices that are used frequently and have a learning curve that requires repeated use to establish reasonable proficiency, testing should allow participants to use the device multiple times, if appropriate.

Data collection should include capture of observational and knowledge task data and should be supplemented with subjective data through the use of de-brief interviews with the participants after the use scenarios are completed. The purpose of the de-brief is to assist with understanding of possible root cause of use errors detected during testing.

Study location

It has long been understood that there is an expectation for the validation testing to be performed in the US. It is an expectation that hasn’t been removed, as the results of studies performed in other countries may be skewed by differences between healthcare practices, cultural and language differences. However, the agency are open to considering exceptions, on a case by case basis, where there is a sound rationale that addresses the differences. In any case, as you might expect, the device, labelling and training must be those that would be used in the US. So, in the vast majority of cases, it is likely that testing in the US would be more straightforward.

When is the guidance effective?

You will have some time to assimilate the requirements…
A whole 5 weeks, as they go live on 3 April 2016.
How will these changes will affect your product development?
What impact they will have upon your Human Factors Engineering programme?
Get in touch today to discuss how you can best navigate the changes and emerge with a Human Factors programme that is “just right”.