As you’re watching this video, it’s safe to say that you’re at least curious about how to get your medical device approved for sale in the European Union.
Still with me?
Then we’ll begin.
If you had a sense of what you needed to do, to take care of this, what would you then do?
After watching this video, you may want to think about how you’ll put what you learn into action.
In this bite-size video, we’ll take a look at some of the key things you’ll need to do, before you can sell your medical device in the EU.
To be clear, we’re looking here at the Medical Device Regulation, as we’re now less than a year from the end of its transition period, in May 2020. To make our lives easier, I’ll be referring to it as the MDR.
If you’re curious about what’s changed from the Medical Device Directive, we summarised the main points in an article a while back. There’s a link in the transcript for this video and on screen right now.
In the time available, we can’t go into great detail. So please get in touch to find out more.
Medical Device Classification
First off, you should be aware that medical devices are grouped into “classifications”, according to the risk they present to the user and patient.
There’s a process you follow to find out which Class your medical device fits into. It’s described in lots of detail in Annex 8 to the MDR.
Classes increase in risk from the lowest, Class I through to Class III.
Class I medical devices
So we have the simplest, least risky devices sitting in this Class I.
Basically, these are non-invasive devices that don’t store or channel body parts or fluids.
However, if your Class I device is provided sterile, or it measures something, or is a reusable surgical device, it is viewed as slightly more risky, so it’s treated differently.
I refer to these as Class IR
Class II medical devices
Class II is split into 2 parts:
Class IIa are short term use, invasive devices, including many surgical, and some active devices
Class IIb are long term use, invasive devices. This includes implantable devices, long term surgical devices as well as some active devices
Class III medical devices
Pretty much all remaining devices fit into Class III, including those in direct contact with the heart, circulatory or nervous systems.
This isn’t an exhaustive list for each class, as that would take us over an an hour to go through, and neither of us want that, do we?
Getting Classification of your device right is important, as it determines what you must do to get your CE Mark to sell it across the EU.
Some parts of the MDR are only relevant to specific classes and types of devices.
7 Steps to CE Marking
However, no matter what the classification, you will go through 7 steps.
You must have an appropriate Quality Management System (QMS) in place and in use.
Except for the simplest Class I devices, this most often means getting ISO 13485 certification for it.
The simplest Class I devices don’t need to have that independent review, but it’s probably a good idea, so you know you’re doing the right things.
You need a comprehensive technical documentation file for your device.
For everything above a simple Class I device, that also means testing reports, Clinical Evaluation and Risk Management documents, labelling and a Unique Device Identifier.
The simplest Class I devices have lower documentation needs, remember they’re still very important.
All classes of devices must demonstrate how they meet the “General Safety and Performance Requirements” in Annex 1 of the MDR.
If you’re outside the EU, you must have an “Authorised Representative” in an EU country.
Their details must be added to your device label, and you’ll need to register them with the EU regulators.
Except for the simplest Class I devices, you must have an audit by a Notified Body.
There are very few Notified Bodies designated for the MDR, so you’ll need to get on and speak with them now, if you haven’t already, to get time in their diary for your audit and any pre-work.
Their diaries fill up rapidly, so do bear that in mind.
The audit will look at your Technical File and QMS. You need to have a good audit outcome for both of these to be awarded your CE Mark.
Your CE Mark is valid for 5 years, and is reviewed when your Notified Body does their yearly re-assessment of your QMS. Without the continuing certification of your QMS, your CE Mark will not be valid.
Now, you can sign your Declaration of Conformity – which says that you comply with the MDR. This is essential.
You’ll need to register your medical device and its Unique Device Identifier with the EU. Remember, the UDI must be on your device label.
Now you can market your device in the EU.
Once your device is on the market in one or more EU countries, you must undertake post-market surveillance. You must also keep both your Technical File and Clinical Evaluation up to date.
For all but the simplest Class I devices, you’ll have annual Notified Body audits, to ensure you’re still complying with the MDR.
And if you’re still with me after all this, well done.
To get your one page reminder of everything that we’ve just gone through, email email@example.com
As you watched this video, you’ll have started to think about how you can go about addressing each of these steps properly, making the best of each part of your journey. You may now want to get some guidance to turn your thoughts into concrete actions.
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