This is a multi-part post.
Part of the problem in understanding regulations and standards is the fact that they usually have requirement (the “what” you need to achieve), but now the solution to fulfill the requirement (the “how”).
From discussions and several years of training and implementation of the requirements of the EU MDR 2017/745, I see people have a lot of difficulties in understanding some of the requirements and how to fulfill them (usually because they try to see the MDR as “just another set of regulatory requirements” and not as “World shaking paradigm change in medical device regulation 10.0“ as it should).
So, this is a list of comments, for several Articles and Annexes, on approaches to the “how” of compliance.
This not an exhaustive list (each Article and Annex have several “hows”), but only a list of the things that seems more impactful.
Also, these are my views, so everything may be totally wrong. Read at your own risk!
For comments and discussions, I suggest going to this post on the Elsmar Cove – https://elsmar.com/elsmarqualityforum/ (look for the Medical Device and FDA Regulations and Standards News thread).
– Whereas (preambles):
If you’ve got the Official Journal text of the Regulation, it will come with the preambles (begins with Whereas). There’s 101 of those! Most people simply ignore them (some do not even know they exist, because the copy they have is the one without it).
I suggest you read them entirely. They explain the reasons for the requirements in the Regulation (if you really want to understand even more the historical development, you should read at least the four pdfs of the IMPACT ASSESSMENT ON THE REVISION OF THE REGULATORY FRAMEWORK FOR MEDICAL DEVICES Parts 1-4 and the 12 or so versions the the draft text, including the political agreements).
– Article 1
The Regulation in fact is for 2 things:
1 – Rules for placing on the market of medical devices for human use accessories for such devices in the EU (in fact there’s 3 things here, placing on the market, making available on the market or putting into service, but to facilitate I will use only the first. If I need to separate to show the requirements correctly, I will). The “human use”part also means that it does not apply to veterinary-only products.
2 – Rules for conducting clinical investigations of medical devices and accessories in the EU.
For several reasons, it also encompasses some devices which do fall into the definition of medical device but are so like medical devices that they are better regulated under this same Regulation (the ones in Annex IV).
If your device has “different stuff” such as drugs, this article also spell out which other requirements the device has to comply with.
– Article 2
There’s some changes in the definitions that are subtle and you have to take care with them.
One of the most impactful may be the change on “implantable devices”, where they changed “surgical intervention”to “clinical intervention” in both instances (this was because of the incorporation of the AIMDD). This will probably change several devices which were not implantable to implantable (which is a practical problem, as implantable devices have several additional requirements in the Regulation).
One very important definition is “benefit-risk determination”, which is in practice the most important activity the manufacturer has perform for each product to comply with the General Safety and Performance Requirements (the old Essential Requirements). Note that this activity has to be iterative, repeated in the device lifecycle (the idea of the regulations is that you have to continuously measure benefit and risk, and confirm that your device benefits outweigh the risk).
One important change in the definition of “Clinical data” (change from the current MEDDEV 2.7.1 Rev 4) is from “published and/or unpublished reports” to “reports published in peer reviewed scientific literature”, which will limit the clinical data that can be used (this in fact is a trend, the regulation puts a lot more restrictions on which clinical data can be used, in particular for Class III and implantable devices).
– Article 5
Risk management and Clinical evaluation (use of clinical data) are the base pillars of the Regulation, thus they are spelled out front in this article (they were inside other requirements in the MDD text).
– Article 6
This one deals with the advent and spread use of the Internet.
– Article 7
This is the clear incorporation of marketing requirements (a usual focus of FDA regulations due to the history of how that regulations were created) into this Regulation.
One important thing – this is not part of the conformity assessment of a Notified Body, so you are in your own. If something is not complied with, you will receive a call or visit from a CA.
Also, note that to comply with these requirements, you need to have regulatory control of any information about the device that comes from the outside world, including procedures to verify if that information “mislead the user or the patient”.
By experience, this is a difficult requirement, because it’s not easy to control the marketing department 😛
That’s it for now. Until the next part!
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