Tag Archives: regulation

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”.

FDA finalises Human Factors Guidance – Part 2

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”.

FDA HF guidance FINALIn part 1, we looked at both the Human Factors Engineering process and Risk Management and Human Factors, two of the key topics covered by the Center:

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

Lets look at how the topic of Design Verification may impact what you’re either already doing, or plan to do.

Design Verification

Design Verification has vanished from a Human Factors perspective – probably a relief for device development teams who were scratching their heads about what was needed in addition to Design Verification as described in ISO 13485 and 21 CFR §820.30 Design Controls.

So now, we can focus on Design Verification being all about confirming that the design outputs (i.e. the device design and associated specifications for performance and attributes) meet the design inputs (what you wanted the device to be able to do). It’s about physical evaluation and testing of devices to confirm, for example, that the force required to turn a dial meets your specification limit. To confirm that the robustness and mechanics of your design function as intended.

Now that might sound straightforward, just get some sample devices from (pre-)production and test them, right?

Design Verification tests shouldn’t be “tick box” tests. Sadly, that’s often what is done by way physical testingof Design Verification, however this misses the fundamental point of verifying the design – to confirm that the device performs as required, throughout the range of your specifications. Design Verification demonstrates that devices manufactured/assembled with components from all across your specified ranges actually do work together, and more than that, they work as intended. Verification shows that your “design envelope” works in practice. It also gives you reasonable confidence that, when your manufacturing and assembly processes vary (within your specification) which they will do, the end product is safe to place on the market. And in the long run, that should mean less surprises.
Certainly, the scale of Design Verification can vary hugely, depending upon the number of components, their manufacturing process variability and so on. But it doesn’t need to be a big deal.

You need to be able to rely on the results of Design Verification

Taking care to plan, design and execute DV is a great step on your journey to getting your product on the market. Consider how you will know you can rely upon the data that are generated and analysed.

We’re often asked whether test equipment need to be qualified and test methods validated? You could take the approach of using development equipment and test methods that are not yet optimised. How will you be able to show, to your board and investors, that DV is truly representative of production data?

The long and the short of it is;

  • Qualify your test equipment before using it for DV,
  • Optimise and then validate the test methods you plan to use during DV.

Take both steps and you’ll have a high degree of confidence that the results you get are translatable to production and routine inspection situations. And there’s the added bonus that you would have needed to do the work anyway during industrialisation and launch preparation.

Spare yourself the nightmare of discovering at that late stage that there was a critical issue with the way you planned to release batches of product onto the market.

When is the guidance effective?

You will have some time to assimilate the requirements…

A whole 6 weeks, as they go live on 3 April 2016.

How will the 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 Design Verification programme that is “just right” – you know, “fit for purpose”.

FDA finalises Human Factors Guidance – Part 1

We’re just over a month in to the year and the FDA’s CDRH have published a final version of their guidance “Applying Human Factors and Usability Engineering to Medical Devices”.

FDA HF guidance FINALThe document, published on 3 February, is the result of nearly 5 years of consultation with industry since releasing a draft guidance back in 2011.

Detailed examination of the published guidance is probably a topic for another time (as there’s lots to discuss). For now, I’ll make you aware that it contains some key bits of information about:

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

In this and subsequent posts, we’ll look at how they may impact what you’re either already doing, or plan to do.  Let’s get started with the first two topics.

Human Factors Engineering process

The expectations of your HFE process have been simplified, harmonising with ISO 62366. They’re closely aligned with how we’ve been supporting our clients’ HFE activities.

It may be that your process for HFE is either too simplistic for what’s required (e.g. just focussing on usability of the device), or sits out of alignment with the agency’s expectations. Take the time now to review what you have in place and identify where changes may be required.

ISO 62366 process flow

Usability Engineering and Risk Management in ISO 62366

Risk Management and Human Factors

As with last year’s revisions to ISO 62366, there’s now a clear emphasis on Risk Management from the User’s perspective (aligned with ISO 14971: Application of risk management to medical devices), throughout an HFE programme. The concept of a hierarchy for risk elimination or reduction measures by and large remains intact, however there are now 3 levels;

  • Inherent safety by design;
  • Protective measures in the medical device or the manufacturing process;
  • Information for safety.

As you’ll probably be aware, the agency expects risk mitigation measures to start at the top of the hierarchy.

Users and Use Related Hazards are placed front and centre, with the importance of identifying and categorising (for subsequent risk control activities) the Critical Tasks in using your device (or combination product) underlined through extensive discussion in the guidance document. Indeed, this part of the published guidance includes techniques like Task Analysis, Heuristic Analysis and Expert Review as your initial basis for risk identification.

Risk Management activities now play a bigger part in the analysis and reporting of your HF Validation Study. Reporting that must include an examination of residual risks, and an overall Usability risk-benefit analysis conclusion for the developed product.

Perhaps now is a good time to have an independent review of your Risk Management plan, activities and documentation to ensure they are ready to meet the agency’s newly published requirements for Use Related risks.

When is the guidance effective?

You will have some time to assimilate the requirements…

A whole 8 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”.