MDR 2017/745 Classification Guide

#1
I'm starting this thread to discuss the classification of different medical devices according to MDR 2017/745. In this regard, I request experts to give their views

So, being the first can someone guide me about classification rule and class of laryngoscope as per MDD and MDR.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
I'm starting this thread to discuss the classification of different medical devices according to MDR 2017/745. In this regard, I request experts to give their views

So, being the first can someone guide me about classification rule and class of laryngoscope as per MDD and MDR.
Did you give it a go?
What's your outcome?
If you got stuck - where/why?
 

Watchcat

Trusted Information Resource
#3
I'll sort of second RonenE on this one, by saying that you will probably get a better result if you first work through the classification rules yourself. Then, if you find something that seems ambiguous with respect to classifying your device, describe that ambiguity to the forum. As an example, see the recently lengthy discussion on Rule 11 in the sub-forum on EU device regulations.

My second suggestion is that, because MDR 217/745 is a regulation instead of a standard, you might get a bit better response if your post was in that sub-forum than in this one. (RonenE, what do you think?)
 

Ronen E

Problem Solver
Staff member
Moderator
#4
My second suggestion is that, because MDR 217/745 is a regulation instead of a standard, you might get a bit better response if your post was in that sub-forum than in this one. (RonenE, what do you think?)
Thanks, I moved the thread to the "right" forum.
Ronen.
 
#5
I'll sort of second RonenE on this one, by saying that you will probably get a better result if you first work through the classification rules yourself. Then, if you find something that seems ambiguous with respect to classifying your device, describe that ambiguity to the forum. As an example, see the recently lengthy discussion on Rule 11 in the sub-forum on EU device regulations.

My second suggestion is that, because MDR 217/745 is a regulation instead of a standard, you might get a bit better response if your post was in that sub-forum than in this one. (RonenE, what do you think?)
Thanks for guiding me, As I am new on this forum so couldn't differentiate the forum to put it in the right thread. I have studied the rules so the confusion is that Laryngoscope consists of two parts one is the handle containing a battery (which surely is active) but the other one that is laryngoscope blade that just depresses the tongue and illuminates the light either through optical fiber or through bulb (whichever is installed with blade). Firstly, I want to know that can I classify these two parts as one. If yes then under which rule.
Rule 5 class I if we consider this non-active as whole or Rule 10 clause 1[except for devices intended to illuminate the patient's body, in the visible spectrum, in which case they are classified as class I].
 

twanmul

Involved In Discussions
#7
I think you're getting tied up here on whether it is active or not based on the handle.
In reality, your device is active irrespective of the handle as the light (which is encompassed in the blade) relies on an energy source external to the body. You could classify the battery separately as an accessory but in reality you're best combining the classification.
You're also getting tied up in what single rule to apply. I think both of your quoted rules apply as your device is both an invasive device of the oral cavity and is active.
You should therefore classify this using both rule 5 and rule 10.
Under rule 5, if the device is only intended to be used in the oral cavity as far as the pharynx, then it is Class I (Class IIa if further).
Under rule 10, if the device is intended to illuminate the patient's body in the visible spectrum, then it is also Class I.
These rules aren't mutually exclusive and you can combine them, taking the highest risk classification. In this case, they are the same risk classification and so Class I applies. If the device is used further than the pharynx, then the higher risk classification of Rule 5 would apply and Class IIa would be the result.
 
#8
I think you're getting tied up here on whether it is active or not based on the handle.
In reality, your device is active irrespective of the handle as the light (which is encompassed in the blade) relies on an energy source external to the body. You could classify the battery separately as an accessory but in reality you're best combining the classification.
You're also getting tied up in what single rule to apply. I think both of your quoted rules apply as your device is both an invasive device of the oral cavity and is active.
You should therefore classify this using both rule 5 and rule 10.
Under rule 5, if the device is only intended to be used in the oral cavity as far as the pharynx, then it is Class I (Class IIa if further).
Under rule 10, if the device is intended to illuminate the patient's body in the visible spectrum, then it is also Class I.
These rules aren't mutually exclusive and you can combine them, taking the highest risk classification. In this case, they are the same risk classification and so Class I applies. If the device is used further than the pharynx, then the higher risk classification of Rule 5 would apply and Class IIa would be the result.
Thanks for your reply. all I got is that we have to mention risk class like Class-I is for our case, there is no concern whether we mention this in rule 10 or 5 as risk analysis would be the same?
I was thinking, If we mention this in rule 10, we would be classifying this as active so is there any special requirement in that scenario?
 

dgrainger

Trusted Information Resource
#9
Don't forget the 3rd clause of rule 10 as the you may be claiming that the laryngoscope is 'intended to allow direct diagnosis' = IIa or 'intended for diagnosis in clinical situations where the patient is in immediate danger' = IIb.

Direct diagnosis is now defined:

3.7. A device is considered to allow direct diagnosis when it provides the diagnosis of the disease or condition in question by itself or when it provides decisive information for the diagnosis.​

There is an argument now that a laryngoscope should be class IIb under this updated rule!
 
Thread starter Similar threads Forum Replies Date
Q Harmonised Standards (EN ISO 13485 / EN ISO 14971) in MDR (2017/745/EU) ISO 13485:2016 - Medical Device Quality Management Systems 3
A Can anyone share a Distribution Agreement template under MDR 2017/745? EU Medical Device Regulations 0
K Applicability of Cybersecurity EU MDR 2017/745 Annex 1 23.4(ab), 14.2(d) CE Marking (Conformité Européene) / CB Scheme 3
K Applicability of eIFU as per EU MDR 2017/745 Annex 1 23.1 CE Marking (Conformité Européene) / CB Scheme 0
R Declaration of conformity as per EU MDR (2017/745) CE Marking (Conformité Européene) / CB Scheme 5
K Supply Agreement Regarding MDR 2017/745 - Manufacturer-supplier cooperation Other Medical Device Related Standards 0
T Commission proposal being drawn up for postponement for date of application of MDR (2017/745) EU Medical Device Regulations 7
F Will the EU postpone 2017/745 MDR Implementation - COVID-19 Impact Medical Device and FDA Regulations and Standards News 11
M Informational Is my device a Reusable Surgical Instrument under the EU MDR(2017/745)? Medical Device and FDA Regulations and Standards News 0
M Informational EU – Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 2
dgrainger Informational MDCG 2019-11: Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 0
M Informational New designated Notified Body for Regulation (EU) 2017/745 (MDR) included in Nando – IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. Medical Device and FDA Regulations and Standards News 3
M Informational Some things the EU MDR 2017/745 does not tell you, but you may need to know to comply with it effectively – Part 1 Medical Device and FDA Regulations and Standards News 0
O New MDR 2017/745 Transition Strategy - 2019 Manufacturing and Related Processes 3
xcanals_tecno-med.es Qualification of sterilization indicators as medical devices with the EU MDR 2017/745 EU Medical Device Regulations 7
G Pyrogen Test - Sterilization Validation - MDR 2017/745 Other ISO and International Standards and European Regulations 6
G Pyrogen Test - MDR 2017/745 Other ISO and International Standards and European Regulations 2
M MDR 2017/745 sterile and non-sterile labeling EU Medical Device Regulations 12
M Informational EU – Medical devices: Implementation of Regulation (EU) 2017/745 on medical devices (MDR) – Information from the Irish and German delegations Medical Device and FDA Regulations and Standards News 0
F Interpretation of MDR 2017/745 Article 23 - CE Mark Requirements EU Medical Device Regulations 8
I 2017/745 (MDR) - Instruction for use (IFU) - manufacturer's website EU Medical Device Regulations 19
F MDR 2017/745 Basic UDI-DI, UDI-DI & UDI-PI EU Medical Device Regulations 0
C Usability IEC 62366-1:2015 and MDR 2017/745 - Risk based approach IEC 62366 - Medical Device Usability Engineering 1
F EU MDR 2017/745 Rolling Plan Medical Device and FDA Regulations and Standards News 4
moounir Medical Device Nomenclature - Free of Charge? (European Union MDR MDR 2017/745) EU Medical Device Regulations 7
G EU MDR 2017/745 Rule 11 interpretation - Re-classification of a Software as Medical Device Other Medical Device Related Standards 0
M Informational Scope of BSI for the MDR – Regulation (EU) 2017/745 on medical devices Medical Device and FDA Regulations and Standards News 0
W TF according to MDR 745/2017 CE Marking (Conformité Européene) / CB Scheme 5
D Responsible for regulatory compliance (Article 15 of MDR 2017/745) Quality Manager and Management Related Issues 4
S MDR (Medical Device Regulations 2017/745) training recommendation for Auditors EU Medical Device Regulations 1
R MDR 745/2017 keynote - I'm a student and I'm writing a thesis EU Medical Device Regulations 4
Ronen E Transition to MDR (EU 2017/745) - I'd like to make an offer EU Medical Device Regulations 12
R How to obtain OBL licence under Indian MDR, 2017 Other Medical Device Related Standards 2
M Informational EU – Next Notified Body designated to the MDR 2017/475 is IMQ S.p.A from Italy Medical Device and FDA Regulations and Standards News 0
shimonv The new "features" of the MDR - Dec 2017 EU Medical Device Regulations 4
Sam Lazzara EU MDR Safety & Performance Requirements vs. MDD ERs (June 2017) EU Medical Device Regulations 5
M MDR and IVDR to be published May 5th 2017 EU Medical Device Regulations 14
S MDR & IVDR Introduction in late May 2017 EU Medical Device Regulations 1
I What are suitable indicators and threshold values in MDR/IVDR? Medical Device and FDA Regulations and Standards News 0
A Sell-off legacy devices MDR EU Medical Device Regulations 0
A Eudamed actor registrations if you change AR for MDR product EU Medical Device Regulations 0
Ed Panek Which choice of the following most closely matches the MDR compliance of your company? EU Medical Device Regulations 0
K Definition of SAE under MDR EU Medical Device Regulations 3
Ed Panek Clarity from EC on Importer/Distributor roles in MDR EU Medical Device Regulations 9
Pmarszal BS EN 20417:2021 - Implementation Timeline Aligned With MDR? Other ISO and International Standards and European Regulations 1
T Dental lab acrylics and MDR EU Medical Device Regulations 0
S Biggest issues when producing MDR compliant Technical Files / DD EU Medical Device Regulations 4
A Declaring Conformity with MDR Article 120(3) for an MDD Legacy Device EU Medical Device Regulations 1
D EU MDR - Change of device name (legacy device) EU Medical Device Regulations 4
J Technical Documentation as per MDR / subpoint 6.1 EU Medical Device Regulations 3

Similar threads

Top Bottom