Part 1 – Introduction
MDR transition – Where the heck do I start?
This is the first question when people start to plan the transition of their organization to MDR compliance.
It is not necessary to read the entire MDR and to have all questions answered. In fact the most important step is to re-classify your devices against the new rules.
Yes – “re-classify”! The rules have changed and to simply keep on the same classification is risky. Classification by guts feeling is not an option. Your Notified Body will ask for evidence of a classification assessment and the documented results!
Today I was digging myself through the classification rules of the MDR.
Of course I know that the laser system for eye surgery would be class 2a but how do I document the decision and the data on which the decision is based?
I am a bit lazy and love to have my work as comfortable as possible so I structure the expected work load.
Instead of scrolling up and down through the original PDF or HTML I prefer to use spreadsheets and their grouping features. So I created a spreadsheet containing all classification rules and grouped the rows in a way that allows me to collapse and expand the items I am working on.
You will find a link to that table for free download at the bottom.
Seen from an information technology point of view it should not be too hard to classify a specific device according to the rules.
Quantitative structure of the classification rules
In Annex VIII of EU-Regulation 2017-745 (MDR) there are three chapters
Chapter I
contains the scope and definitions. It‘s good to read it but for the actual classification the use of this chapter is limited. My advice: read it once and note the differences to your expectations if there are any. As soon as I have read the definition I set the field “Status” to “Informative”. So just in case I get interrupted I can easily follow on from where I left.
Chapter 2
is a bit more tricky.
The title “Implementing Rules“ is a bit misleading. In fact this chapter contains the information on how the rules shall be used to classify a certain device. To make it short Chapter 2 contains the “rules of the game“. It is very important to read and understand them.
If one or more rules of the game do not apply to the specific device it‘s good to set the column “Status“ for that rule to “Not applicable“. Later on after having evaluated Chapter 2 I can easily see and demonstrate that I really did evaluate all of them.
The real beast is Chapter 3: Classification Rules.
Chapter 3
is divided in
Non-Invasive Devices: Rule 1 through 4 in 11 sub-rules
- Rule 1 has no sub-rules
- Rule 2 has three sub-rules
- Rule 3 has three sub-rules – it contains three rules but two of them in one sentence
- Rule 4 has four sub-rules
Invasive Devices: Rule 5 through 8 in 24 sub-rules
- Rule 5 has four sub-rules
- Rule 6 has six sub-rules
- Rule 7 has five sub-rules
- Rule 8 has nine sub-rules
Active Devices: Rule 9 through 13 in 18 sub-rules
- Rule 9 has four sub-rules
- Rule 10 has five sub-rules
- Rule 11 has six sub-rules
- Rule 12 has two sub-rules
- Rule 13 has no sub-rules
Special Rules: Rule 14 through 22 in 18 sub-rules
“Special rules” are a special case. I will cover this in one of the next articles.
For a specific device each of the rules is either “yes” or “no” and I can now select the corresponding value in column “Compliant”. In an ideal world I would end up with just one one “yes”.
Unfortunately it is not that easy as the regulation has 12 cases where in a single sub-rule you have to decide which class applies. In this cases I select “Ambiguous” so I need to look a bit more into the details.
All other cases it is obvious immediately which classification I should use. The column “Compliant By:” takes the source of the information based on which I did the decision. If there is no such source I enter a comment in column “Specify Gap Description” and know that I have to fill the gap and may add a link to the according task in the QMS.https://mdrtools.eu/mdr-rules-assessment-tool/
The classification rules for Non-Invasive Devices is covered Part 2.