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:
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
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
Unique Device Identifiers will be introduced, similar to the system in place for the US market
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
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
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)
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
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
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
Devices like coloured cosmetic contact lenses, without a medical purpose but with characteristics similar to medical devices, will fall within the scope of MDR
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
If you aren’t already, you will be required to use a Quality Management system
The Essential Requirements have grown, so you’ll probably want to review and update your Essential Requirements checklist
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
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.
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.