Monthly Archives: October 2017

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,

Medical Device Development – How to get the best possible return on your investment

Bringing a medical device to market requires significant investment of time, money and resources.

In our experience, the precise amounts of all three needed to successfully complete development, industrialisation and launch varies, depending on the nature, complexity and risk associated with the product.

It is not unusual for a low to moderate risk device to take 3-4 years to reach the market, supported by development investment of up to around $30million. As the device risk and/or complexity increases, so does the investment; by comparison, a complex, high risk device may take upwards of 6 years and $90 million to bring to market. There are no guarantees, of course, that the device will ever make it to the market or, if it does, that it will be commercially successful but for those that are, the rewards can be significant.

So the medical device development process can often be a perfect storm —high risks, high costs, lengthy development timelines that can eat into the revenue generation window, and potentially relatively modest returns—has created a difficult environment for medical device innovation. If you’re in this challenging environment, you’ll want to focus on strong management of process to mitigate risks and minimise time and investment, whilst ensuring your development roadmap doesn’t cut any corners.

In our experience, gained from over 25 years in device development, you stand the best chance of success if you focus on three critical factors;

  • Mitigating Risks
  • Controlling spend
  • Optimising project timescales

Mitigating Risks

To mitigate risks, first there has to be an understanding of the potential risks in the development process and secondly a plan to minimise their impact and mitigate them as far as is practical and cost effective.

Controlling Spend

Controlling spending is not just about spending wisely and getting best value, but also about making informed investment decisions (based on sound data and experience) to reduce risk by investing proactively in key areas. Sometimes, money spent in the right areas early on in the development process can save significant sums later on – the cost of quality effect.

Optimising project timescales

Optimising project timelines involves identifying key decision points and ensuring you have the data you need to make robust decisions when and where they’re needed, preventing unnecessary work or racing down a flawed development path. Creating the least impact on project timescales steps back from the fallacy of planning a “best case” project timeline, which almost inevitably falls apart at the first hurdle and ends up costing far more than budgeted and taking years longer to deliver (if at all). Instead, it looks in detail at the individual project elements and avoids the temptation of cutting corners to create a more robust, realistic, affordable and achievable plan for development through to launch and beyond.

That’s a lot to consider, no matter what development stage you’re at.

How to ensure medical device development goes smoothly

To ensure things go as smoothly as possible, when we’re brought into a project to deliver a specific piece of work we offer clients the option of a scoping day, assessing collaboration prerequisites and risk factors in a pre-collaboration checklist.

This builds the foundation for a successful working relationship, with no surprises, and enables us to help you avoid the pitfalls that can stop, stall or even derail a project completely.