I think we can all agree that the Medical Device Regulation (MDR) is no picnic.
To begin with, the MDR text is a lot to take in. It’s partly very detailed, partly very vague. Easy to get wrong if you’re unfamiliar with regulations or the union market.
The MDR implementation contains several transitions and extensions. Critical deadlines have been moved again and again. It takes an effort to keep up with who needs to do what by when.
The advice and interpretations of the MDR vary. And keep on evolving. Notified bodies and competent authorities are not always aligned on their feedback to manufacturers.
As you can imagine, all this has created misconceptions about the MDR.
If you’re in the middle of an MDR transition or starting your MDR ride, but feel your head is spinning, I understand you. I’ve seen many device manufacturers, distributors and importers go through the same thing.
To help you avoid some of the MDR misunderstandings that could cost you time and money, let’s go over 3 MDR misconceptions and debunk them.
1. ”Only medical companies can manufacture medical devices”
When the talk around the MDR focuses on the medical device industry and typical images show implants, syringes and people in white coats, it’s understandable one can start to doubt whether they fit in if they don’t match the pattern.
However, when you look at Eudamed, you see a different picture.
There are currently over 20 000 device manufacturers registered in Eudamed.
Those manufacturers operate in a wide variety of industries.
For example, you can find companies from software, interior textile and paper manufacturing industries.
This could, in fact, make you wonder what is medical device industry anyway. How to define it? Well, let’s get back to that another time…
I see the diversity of medical device manufacturers in my work too. I would not recommend ignoring the MDR just because you’re not a stereotypical medical device company. I’d say you’re on the right track if you start by looking at the intended purpose of your device instead.
2. ”Paying customers usually decide if our device is a medical device”
It’s great when a company puts their customers first.
However, under the MDR manufacturers will actually do a disservice to their customers if they outsource their responsibilities to them.
The reason is that MDR places plenty of obligations to manufacturers.
Such as defining whether their device fits the definition of a medical device.
And if it does, it’s the manufacturer’s job to make sure the device meets the general safety and performance requirements.
This includes having appropriate risk management, labelling and instructions for use in place when the customers use the device. If any patient harm is reported, the manufacturer needs to step in to analyse what went wrong and try to make sure it doesn’t happen again.
If a manufacturer neglects to do their part, they’ll run a big risk of getting the authorities’ attention and damaging their company’s good name.
Trust me, it’s not worth the risk.
A smart first move would not be to hand over the medical device decision to another party, such as customers. Manufacturers need to hold the reins. They can minimise regulatory and business risks by educating themselves about the MDR and what their role and responsibilities are.
3. ”Technical information equals technical documentation”
Especially small newcomer manufacturers and class I manufacturers sometimes present technical data, memos, records, certificates, signed testimonies, etc. as their current technical documentation when I try to perform an MDR gap analysis.
Don’t get me wrong. Technical information is essential building material for meeting the MDR requirements. It’s just not…technical documentation as per the MDR. At least not yet.
What the MDR technical documentation refers to are documents that have been written to provide the story of how the device and the manufacturer meet the requirements of the MDR.
We’re talking about documents such as risk management file and clinical evaluation.
They are expected to be crafted so that the notified body or competent authority understands what the device is, what it does and convinces them that the device is safe to use.
In practice this means that the manufacturer uses the valuable technical information as a starting point. The information is put into context, analysed, explained, accompanied by rationales, the meaning of findings is clarified so that external non-experts of the device are able to assess its conformity to the MDR.
It’s good to understand the difference between technical information and technical documentation. Having correct and clear technical documentation can make your MDR conformity assessment much shorter.
There are many MDR misconceptions circulating. Some are due to not understanding a regulated industry let alone the MDR. Others are the result of copying someone who also didn’t have a clue what they’re doing. Not asking for help when you need it can lead to misunderstandings persisting for a long time.
You can make the MDR easier by taking the time to get to know it better. To know more and assume less is a good strategy.
Have you noticed any other MDR misconceptions? Please share them in the comments. I’d be curious to read about your experiences.
In case you have questions or concerns about the MDR, you’re welcome to send me a message. I’d be happy to listen to what’s on your mind and help you take the next step.