EU MDR is undoubtedly a fantastic way of upgrading the medical device market quality, but the process is anything but easy. With the slow but steady transfer of MDD to MDR, various aspects of requirements regarding medical device regulation are changing every day. With that comes new regulations and, with that, new documents for us to read and learn.
Finding the more important documents is nearly impossible for anyone who has not kept up with the almost weekly changes. So, of course, we came up with a list of must-read documents you need in your journey to get EU certified!
Where to get the documents?
Before we delve more into the details, first things first! Where does one get all the documents they need to follow the EU MDR guidelines perfectly?
Well, the first place to check would be on the EU.gov website. Most regular updates are usually given there. However, there are tons of official websites of EU MDR, all for different purposes, so the best idea is usually to write your concerns in a search engine and sift through the results. For example, If I needed details of IVDR and the current regulations regarding these devices, I would just google “IVDR EU MDR,” and the relevant links should show up quickly enough.
However, for those of us that are working on getting a device to get MDR certified, most of the time, there is no exact concern we have or document we are searching for. Instead, the struggle is always to ensure you have everything covered and are not forgetting any concerns. So, for us, a checklist or even a plain old list of essential files that we absolutely should take a look at is a lifesaver.
To find these, I would recommend taking a tour of the European Commission’s Public Health page. There is a lot of valuable content to be found there. However, while you do that, check out the following documents and read through them at least once!
MDR Guidance Documents to Read
Factsheet for Manufacturers of Medical Devices:
A handy document
Ongoing guidance documents:
This is a very handy list of the ongoing guidance development and deliverables of MDCG Subgroups.
If you are looking to ensure your team is ready to face the upcoming changes, or you just want to ensure your device is compliant with MDR, you will want to go through this list.
Borderline and Classification:
Then we have these documents. Of course, you will need to review your medical device classification as soon as you start working on getting MDR approved, so these documents are the first ones to read carefully. Nevertheless, even if you are done with the initial paperwork, check for updates here to ensure the device classification is correct before submission. The most recent classification rule is the “Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices,” which was uploaded this April.
Class I Devices:
Class I devices are mostly harmless, so just ensure they follow the 2020 EU regulation, and that should be it.
Clinical investigation and evaluation:
EU puts a lot of emphasis on clinical investigation and evaluation. Hence, you will regularly find newer updates regarding clinical evaluation in the EU portal. The most recent one is the “MDCG 2021-28”. It involves “Substantial modification of clinical investigation under Medical Device Regulation.” While you are at it, also check the “MDCG Clinical evaluation assessment report template.” This will almost always come in handy. Also, check the “Summary of safety and clinical performance” published this year, which you will need to complete the safety reporting and clinical evaluation.
Documents regarding covid-19:
Covid-19 has almost passed for the general public. But, for the medical device manufacturing community, the pandemic has shown us just how much we lack in safety protocols. As a result, the EU published a “Notice to 3rd country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices” to ensure all preventive measures are in place, especially for the sensitive IVDRs.
EUDAMED is the latest talk of the town. There have been numerous updates regarding the launch of the online/IT system developed by the EU. As of now, EUDAMED is not fully functional yet. However, there are updates and regulations on how things will be handled until it is. For example, just last month EU published “Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional.” You will likely need to read everything from the EUDAMED actor registration module to the recent regulations regarding IVDR to get a good grasp of the soon-to-be-active online platform.
European Medical Device Nomenclature (EMDN):
Just some FAQs and, of course, the nomenclature system itself is sufficient to get you by. One thing you want to ensure is that you are using the correct nomenclature in EU countries. The same goes for implant cards. You want to ensure the device types are mentioned correctly and the associated requirements are met.
In Vitro Diagnostic medical devices (IVD):
Documents about IVD are endless, but almost every one of them is important. Especially, the recent ones changed the regulations pretty dramatically. So, our advice is to always read through them if your company is manufacturing IVDs.
Software and IT devices aren’t new in the medical device sector or are overly complicated. Just make sure to go through these three: Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software and cybersecurity and qualification and classification of software.
Like clinical evaluation, notified bodies are also always relevant. Therefore, there are tons of new updates to go through as well. The good news is that you will always find some blog or other that will explain the complex processes. So unless you need the data, you can skip going through the documents themselves and google its summary. However, make sure you do check for new updates regularly since impressing the notified bodies is an important step of getting registered in the EU.
Unique Device Identifier (UDI):
UDI’s bear the responsibility of introducing your device to the end user. These identifying numbers will be used to trace your devices and improve patient safety. So, getting it right is pretty high on your list. Nevertheless, you will need just a couple of documents for this. So, it should be easy!
There you go. Take a look at the documents mentioned in this list, and you will be good to go for at least most of the MDR process.
What are the guidance documents?
Guidance documents are non legally binding for the most part. The contents of the guidance documents are strongly advised, but you will not get into too much legal trouble for not adhering to them. However, the EU MDR guidance documents are mostly there to help you navigate the complex process of MDR, so they are a must-read.
What is the Blue Guide in the EU?
The blue guide, like the MDR guides, is a non-binding document. It provides information regarding conformity assessments, CE markings, surveillance, etc. It is also a necessary read for medical device manufacturers.