- EU MDR introduces stricter requirements for medical device market quality, with new documents released regularly to help manufacturers comply.
- The European Commission Public Health page is the primary source for official MDR guidance documents and updates.
- Key document categories include device classification, clinical evaluation, documentation requirements, and EUDAMED registration.
- Understanding MDCG guidance documents is essential for navigating device classification, clinical investigations, and conformity assessments.
- Both medical devices and in-vitro diagnostic devices have specific guidance documents that manufacturers must follow.
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 major updates are usually given there. However, there are tons of official publications of EU MDR, all in different places on the latest laws is usually for online and console in a search engine and sift through the results. For example, if needed info on EUDAMED you would simply go for “MDCG + EUDAMED” and the relevant data 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 too much content on those documents and we are absolutely required to. Instead, there are various shortcuts to make sure you have everything covered and are not forgetting any concerns. So, for us, a checklist or even a pain list of all essential files that we absolutely should have a look at are a lifesaver. These 12 documents form the backbone of any complaint EU MDR checklist — and here they are.
MDR Guidance to Read
Flashsheet for Manufacturers of Medical Devices:
A handy single document overview.
Ongoing guidance document development:
This is a very handy list of the ongoing guidance document development and deliverables of MDCG.
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.
Doctrine and Classifications: Of course, you will need to review your medical device classifications as soon as you start working on getting MDR approved, as these documents are the ones that explain everything else you do and as a different process.
On the latest laws is usually for online and console in a search engine and sift through the results. For example, if needed info on EUDAMED you would simply go for “MDCG + classification” — and the relevant information should show up.
The most important classifications rule is the “Guidance on borderline and classification under Regulation (EU) 2017/745 on medical devices” which was adopted in May 2022.
Clinical Investigation and Evaluation
EU puts a lot of emphasis on clinical investigation and evaluation. Hence, you will regularly have to review updates regarding these requirements 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 out the “Summary of safety and clinical performance” as well, and you will need to complete the safety reporting requirements.
Clinical Evaluation
Updates regarding appraisal and considerations for clinical evaluation per MDR Article 61.
Safety Reporting
Guidelines for completing the safety and clinical performance summaries.
Documentation (MDR 51)
Could clinical prevent the general public. But, for the medical device manufacturing community, the requirements for how we just have much work on safety protocols. As a result, the first publication is “Notice to Manufacturers of medical devices and Notified Bodies on CE marking designated medical devices” to ensure all preventive measures are in place, especially for the sensitive field.
EUDAMED
EUDAMED is the central table of all info. There have been some curious updates regarding the MDCG advice (related to the current section). As it may now be used, EUDAMED is not fully functional yet. However, from articles published by the Guidelines Harmonisation and principles for all, we almost got there so I need to start using everything from the EUDAMED — and for registrations as well. It’s a important step of getting registered in the EU.
European Nomenclature (EMDN)
Just some FAQs and, of course, the nomenclature system itself is sufficient to get you by. One thing to definitely be aware of is that you want the device category before starting the registration, as you will get some error messages. You WILL need to use the device category before registration correctly on your UDI-DI records to make sure everything is correct.
In-Vitro Diagnostic medical devices (IVD)
Documents about IVD are endless, but almost every one of them is important. Especially, the new classification rules make sure to go through these three: Guidance on clinical evaluation (IVD) / Performance evaluation / MDR/IVDR specific devices and cybersecurity and qualification and classification of software.
EU MDR Guidance Documents: Your Top Questions Answered
What are the guidance documents?
Guidance documents are extremely technical (and boring) 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 following them. However, without following them, there is no way you can 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 blue guide, is a non binding document. It provides information regarding conformity assessments, CE markings, surveillance, etc. It’s also a necessary read for medical device manufacturers.
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ATTNs Ethan Glasser Dover, Delaware, 19901, United States