Tag Archives: regulation

Getting your medical device into the NHS

Getting a device accepted by the NHS is often described as something of a “dark art”, a mysterious journey into the unknown.  Having a map for this journey would be an attractive proposition.

To flesh out our map for the journey, we joined around 30 other industry experts for Medilink East Midland’s July 2018 conference “How to get your medical device NHS ready”, held in conjunction with Nottingham University Hospitals NHS Trust.

The day covered a range of subjects, all geared towards giving you the knowledge to best prepare your medical device for a favourable review outcome for the NHS.  Amongst the topics we discussed were;

  • The impact of Human Factors in medical device development,
  • Patient Public Involvement – why it’s so important and how to access it,
  • Regulatory support for medical device development,
  • How to undertake a clinical investigation in the NHS,
  • Using a budget impact assessment to support uptake and adoption,
  • NICE engagement and support for developers.

A number of case studies were also shared, demonstrating the value achieved by considering specific topics of the agenda.

We left the event with a clear picture of how our core disciplines supported, and could be woven throughout, the preparations for NHS “readiness”, over and above regulatory authority approval.  We’re now applying that knowledge to help our clients’ development activities.

9 Steps to right first time regulatory compliance

It can be a scary thought, regulatory compliance.  So much to get your head around, so much to make sure is done right, and what is “right” anyway.

Wouldn’t it be handy to have a “crib sheet” to help you get there with less pain, in a shorter time, whilst simultaneously supporting development of a good medical device.

1. The right regulation?

May sound a bizarre first step, yet it is surprising just how many projects don’t adequately consider this question.

  • Be clear about the primary purpose for your medical device, and the mode of action.
  • Then, check the definition of “medical device” in the MDD (Article 1, 2 (a) through to (c)).
  • Does your product fit the description of a medical device? If, yes, then the MDD applies.
  • Does your product fit the description of an in vitro diagnostic device? If yes, then the IVD applies.
  • Does your product clearly not fit with any of the descriptions?  You can get advice (in the UK) from MHRA on borderline cases.  Similarly, you can access EU wide borderline device decisions, and the reasoning.

Remember to also consider other EU legislation that your product may need to comply with.  And, if you have an eye on other markets, look at how their requirements may differ from those of the EU.

2. Are you setting out to solve the right problem?

What is the problem or clinical need that your product is intended to resolve?  Is the problem widespread or isolated to a small aspect of healthcare in one country?

Answering this question will clarify the potential market size and clinical pathway(s) where the device can be used.  Your focus is then narrowed onto developing a product to address a specific need.  You can always expand into other clinical pathways or markets with a future version of the product.

Ultimately, you’ll have started to flesh out the product’s “Intended Use”, the bedrock upon which development rests.  Get this right, and the foundation is secure.

3. Put a Quality Management System in place

Arrival of the Medical Devices Regulation (MDR) explicitly requires a Quality Management System to be put in place for all classes of Medical Device.

The difference between the lowest risk medical devices and the higher classes is one of QMS certification.  For the Class 1, non-measuring, non-sterile medical devices, a manufacturer self-certified QMS is perfectly fine.  Otherwise, a Notified Body certification is needed.  Make sure you adopt the correct QMS certification route for your device.

4. Good Development Practice

“Begin with the end in mind” as Steven Covey said.  As you develop your device, picture how the documentation will come together for the submitted device.

The Design History File and Risk Management activities will tell the story of development, demonstrating why and how you arrived at the eventual solution.

The Technical File will provide the complete dossier of information that describes the medical device manufacture, assembly, testing and release requirements.

Robust, applied Documentation Control and Change Control ensure that you minimise the opportunity for surprises popping up at the end of development.  Start Change Control at an early stage in development, so design decisions are captured and can be referred to easily when answering regulatory authority questions on the submission.

Traceability Matrices should be your (new) best friend – they’re invaluable in ensuring that you’ve covered all the bases during planning, designing, testing and reporting.  If they’re created as you go along, headaches will be smaller than if gaps are spotted when the matrix is created at the end of development.  You may even consider a matrix for the Essential Requirements, to ensure you have documented evidence of compliance with each one.

5. Use Harmonised Standards

Check the most recent update to the European Commission’s list of Harmonised Standards, to see which are relevant for your medical device.  Manufacturers or conformity assessment bodies can use them to demonstrate that products, services or processes comply with relevant EU legislation.  So following the content of a Harmonised Standard is usually the straightforward route to demonstrating compliance.

6. Take care constructing your Technical File

Make it easy for the reviewer to navigate your Technical File, from a high level overview through to the detailed content that they’ll want to read through.  Adopt a logical layout to presentation of information.  There’s a handy template for the content of your Technical File provided by IMDRF (for a medical device, and for an in vitro diagnostic device).  The IMDRF documents are a few years old now, however the MDR contains a detailed description of Technical File content in Annex 2.

7. Your Clinical Evaluation Report

It won’t have escaped your notice that the MDR includes explicit requirements for Clinical Evaluation and its reporting.  There are two major benefits to getting underway with your Clinical Evaluation early in development:

1. The results of your research feed directly into the definition of Design Inputs (what the device needs to be able to do for the user / patient),

2. You have a clear picture of any Clinical testing that is required for the device, permitting realistic budgeting and planning of the project.

8. Post-market Surveillance Plan

Ensure that your QMS incorporates a good system for Post-Market Surveillance (PMS), covering vigilance activities, steps taken for pro-active PMS as well as reactive PMS (i.e. when you’re alerted of a problem, perhaps via a complaint), post-market clinical follow-up.  Naturally, all this is supported by a plan for PMS, that pulls all these threads together and demonstrates how information will be used to instigate or confirm design changes, how PMS information feeds into CAPA, Change Control and Complaint Handling processes.

9.  Managing Devices in the field

Remember to include activities to provide for CE Marking of your medical device prior to placing it on the market (for Class I non-measuring, non-sterile, this can be self-managed, for all other Classes, a Notified Body must be involved).

Consider what requirements you have for any servicing, maintenance and performance verification while the device is in service, and across its in-use life.  These will need to be documented and tested to verify their effectiveness in ensuring continued device performance and safety.

Getting it right, first time

There can be a lot to take in, working through these 9 steps.  Rest assured, help is at hand, should you wish for some guidance or support along the way.  Get in touch today, so we can explore how best to ensure you reach your goal of regulatory compliance, right first time.

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.