Monthly Archives: July 2016

Medical device development; look what you could have won…

Would you like our eternal gratitude… and a small scale model of a speed boat? (yes, really…)

Our inspection lifeboat

Three Circles, the leading medical device development consultancy, have commissioned bespoke research into the industry’s perceptions of best practice, areas of risk, and the causes and impact of delays in the development process for medical devices.

 

 

If you are currently:

  • a director or head of department with responsibility for device development within your organisation (i.e. you manage the team, control the budget and are responsible for the strategic overview and project delivery),
  • A project leader with responsibility for device development projects within your organisation (i.e. you manage the team, manage the budget and are responsible for project delivery),

then we want you to participate in our research.

The research will be conducted by an independent third party who will ensure your participation remains confidential with the results anonymised. The findings will be used to validate our route map for the development process and will be shared with participants.

Along with a copy of the research findings, you will receive our eternal gratitude and a small scale model of a speed boat and we will make a donation to the RNLI for everyone who takes part.

To register your interest in participating, please email me directly (hello(Replace this parenthesis with the @ sign)threecircles.eu) with your contact details.

Fifteen things you need to know about the Medical Devices Regulation

You may have noticed that the “final” draft of the EU Medical Device Regulation (MDR) has recently been published. The draft extends to over 200 pages and includes a mass of changes since the last published version.

While of detailed 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, as the Regulation is not yet 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 mechanics of the EU legal process are these:
    • The Parliament and Council will vote on the agreed texts
    • The MDR will be published in the Official Journal of the European Union (OJEU)
    • Three years later, the Regulation will apply

So, should the MDR be published in OJEU during the Autumn of 2016, the MDR would become mandatory in late 2019. The IVDR would take effect in 2020.

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.