Category Archives: quality

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.

ISO 13485:2016 – time is running out

Something may have escaped your notice in the talk about the revised version of ISO 13485, published in 2016 (ISO 13485:2016 is the International Standard for Medical devices — Quality management systems — Requirements for regulatory purposes).

ISO 13485 is a harmonised standard, which means you can use compliance with ISO 13485:2016 as evidence of conformity with the requirements of several EU Directives:

  • Medical Device Directive (MDD),
  • In-vitro Diagnostics Directive (IVD),
  • Active Implantable Medical Device Directive (AIMDD).

There is a transition period, after which certification won’t be possible to earlier versions of the standard.  To complicate matters, the transition period ends on different dates, depending upon your current certification.


Marketing medical devices in Canada?

You have until 1 January 2019


Current certification to ISO 13485:2003?

you have until 28 Feb 2019


No certification to ISO 13485:2003?

you have until 1 April 2019


In either case, the transition end dates may sound like a long time away yet.  Time flies, and if you’re considering certification to ISO 13485:2016, you have several steps to take, not least of which is to understand what you really must be doing to be ready for certification.  Don’t underestimate the time and effort required to get there.

Help is at hand!

No need to worry about how you’ll get ready in time.  We have helped clients make the transition to ISO 13485:2016 from either an informal Quality Management System, or holding an ISO 9001 certification.  Our experience and knowledge has been assembled into our 13485 Health-check turn key service, to give you a clear picture of how your organisation stacks up against the requirements of the standard. Benefits our clients say they’ve achieved include

A pain free assessment of what you need to do, so you can take the right actions.

Guidance and help for changes you make so you’re not shooting in the dark.

Frees you up to play to your strengths, instead of trying to get to grips with something outside your comfort zone.

What you get when we schedule your 13485 Health-check™:

  1. An on-site gap analysis of your current quality management processes and procedures against the requirements of ISO 13485:2016,
  2. Pre-planned for a date and time that is convenient to you,
  3. Recommendations for improvements or changes to address oversights or weaknesses,
  4. Recommendations for procedures and processes that may be required,
  5. Identification of changes that may be required to your existing procedures and processes,
  6. A comprehensive report detailing the origins of all our recommendations and how they relate to ISO 13485:2016 clauses,
  7. Time with us to create your action plan to address the recommendations.

All this for a single, fixed, fee.

Whether you hold certification to ISO 13485:2003, ISO 9001 or not, we can help ease your transition activities.

Get in touch now, before that clock gets any closer to zero.

 

 

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

Thing 2.

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

Thing 4.

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

Thing 5.

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

Thing 6.

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)

Thing 7.

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

Thing 8.

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

Thing 12.

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

Thing 14.

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,