SBS - The best value in QMS software

MDR Rule 10 interpretation - Active Device

piccoto

Starting to get Involved
#1
Hi everyone,
I'd appreciate your interpretation of Rule 10.
Is ANY active device intended for diagnosis and monitoring should be classified as class IIa, or is it only if the device is BOTH active device intended for diagnosis and monitoring AND either one of the "if" sections?

Do we read it with full stop after the first sentence :
Active devices intended for diagnosis and monitoring are classified as class IIa ?

This is the rule as appears in the MDR -

Rule 10 -
Active devices intended for diagnosis and monitoring are classified as class IIa:
— if they are intended to supply energy which will be absorbed by the human body, except for devices intended to illuminate the patient's body, in the visible spectrum, in which case they are classified as class I;
— if they are intended to image in vivo distribution of radiopharmaceuticals; or
— if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters and the nature of variations of those parameters is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of the central nervous system, or they are intended for diagnosis in clinical situations where the patient is in immediate danger, in which cases they are classified as class IIb.


Thanks :)
 
Elsmar Forum Sponsor

Tidge

Trusted Information Resource
#2
I'm aware of devices which (in the past) almost certainly should have been classified as Class IIb, but were self-identified by the manufacturer as Class IIa... and the NB of the time accepted them as class IIa, and that classification has been used ever since. I can try to offer an explanation about why a IIa classification stands as a sort of superset of IIb without much questioning:

The devices I am thinking of are providing indicative information about a patient status as opposed to decisive information. This line between providing indicative and decisive information is a little blurry for multiple reasons, including:
  • Certain users will immediately look at a particular patient parameter and immediately make a diagnosis without recognizing that the device itself isn't making the diagnosis but instead that the user is making the diagnosis.
  • Manufacturer's often make serious (marketing) claims about how a certain device is improving patient outcomes because of the way that device contributes to diagnoses. Sometimes this form of 'exaggeration' leads (backs?) a company into a higher classification.
I recall a 2012 COCIR recommendation to add a definition for "direct diagnosis":

"A device is considered to allow direct diagnosis when it provides the diagnosis of the disease or condition by itself or when it provides decisive information for the diagnosis.”
This was not adopted but I think this definition offers some clarity, especially on the first bullet point above.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Is ANY active device intended for diagnosis and monitoring should be classified as class IIa, or is it only if the device is BOTH active device intended for diagnosis and monitoring AND either one of the "if" sections?
Neither.

IIa is the default classification for active devices intended for diagnosis and monitoring.

The rule lists several exceptions:
- If they're only intended to illuminate the patient's body, in the visible spectrum, they're class I.
- if they are specifically intended for monitoring of vital physiological parameters and the nature of variations of those parameters is such that it could result in immediate danger to the patient, or they are intended for diagnosis in clinical situations where the patient is in immediate danger, they're class IIb.
- If they're intended to emit ionizing radiation for diagnostic radiology, they're class IIb.

Note: For a device to be "intended for diagnosis and monitoring" it doesn't have to provide the diagnosis or information decisive in making the diagnosis. It merely needs to be intended to provide information contributing towards diagnosis and monitoring, i.e. informing the user about the patient's state (for "monitoring" - in real time).
 
#5
Hi,

First post on this excellent forum.

I have a specific question related to rule 10 and ECG devices. Would ECG devices in general be considered to be class IIb under rule 10? I have noticed several blog posts on MDR rule 10 referring to ECG as an example of a class IIa device. Am I misinterpreting rule 10? Or are the producers of ECG devices formulating their intended use statement such that they are avoiding the class IIb? Or are the blogs claiming that ECG equipment is class IIa wrong?
 

dgrainger

Trusted Information Resource
#6
Take a look at MEDDEV 2. 4/1 Rev. 9 - DocsRoom - European Commission
P42 & 43 look at Rule 10, of note is:

Examples of special concepts:
Note 1: Vital physiological processes and parameters include, for example respiration, heart rate, cerebral functions, blood gases, blood pressure and body temperature. Medical devices intended to be used for continuous surveillance of vital physiological processes in anaesthesia, intensive care or emergency care are in Class IIb, whilst medical devices intended to be used to obtain readings of vital physiological signals in routine check ups and in self-monitoring are in Class IIa. A thermal imaging device intended to monitor blood flow is not considered to be a temperature measuring device.

It would therefore depend on your use case.
 
Thread starter Similar threads Forum Replies Date
R MDR Software Rule 11 Formal Interpretation 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
N Medical Device Classification under MDR - Rule 21 EU Medical Device Regulations 11
K EU MDR Rule 11 - Does the 'Risk logic' used in Rule 11 conflict with that used in the other rules? EU Medical Device Regulations 2
M Informational EU MDR Classification Rule 11 – what??? Medical Device and FDA Regulations and Standards News 9
A Please explain MDR Rule 11 to me EU Medical Device Regulations 67
J MDR Annex VIII, Rule 6 Classification - Implication for lower risk CV products? CE Marking (Conformité Européene) / CB Scheme 3
C Substance based Medical Device Classification under MDR - Rule 21 EU Medical Device Regulations 9
M Responsibilities of Importers / Distributors - MDR EU Medical Device Regulations 0
S PSUR - MDR First Submission Requirement? EU Medical Device Regulations 2
R EU-MDR Article 9-common specifications Other ISO and International Standards and European Regulations 2
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
JoCam MDR Gap Analysis - Consultant fees EU Medical Device Regulations 9
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
M Examples of Combination Products - MDR Article 1 (8) and MDR Article 1(9) Medical Device and FDA Regulations and Standards News 3
P EU MDR Translation of Product Name EU Medical Device Regulations 0
N Is this a single integral drug device combination product EU MDR CE Marking (Conformité Européene) / CB Scheme 1
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
K Quality Agreement MDR - The manufacturer is outside of EU Other Medical Device Related Standards 3
M MDR - eIFU - When you can supply an electronic IFU instead of a paper IFU EU Medical Device Regulations 5
M MDR harmonized standards EU Medical Device Regulations 2
cscalise RAPS/Med Dev EU MDR Guidebook - Reviews or Opinions? EU Medical Device Regulations 0
V New Product Model CE Mark Certification under MDR EU Medical Device Regulations 0
E MDR PRRC "jointly responsible" EU Medical Device Regulations 1
J Strategy for MDR Regulatory Compliance Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
S EU MDR Annex I Chapter III 23.4 z EU Medical Device Regulations 2
R MDR & depth of technical files review by NB's EU Medical Device Regulations 18
U EU-MDR: Complicated supply chain EU Medical Device Regulations 4
C EU MDR - Annex II 6.1 Pre-clinical and clinical data EU Medical Device Regulations 4
A IVD in MDR procedure pack EU Medical Device Regulations 2
Ed Panek IFU Contact Requirements - FDA and MDD/MDR US Food and Drug Administration (FDA) 1
S Are EC type examinations still being conducted under MDR? EU Medical Device Regulations 5
U MDD Article 12/ MDr Article 22 interpretation EU Medical Device Regulations 2
E MDR internal audit Medical Device and FDA Regulations and Standards News 0
R The term "Benefit Risk Ratio" in EU MDR, do I need to present benefit risk analysis as a RATIO Risk Management Principles and Generic Guidelines 4
R MDR, Annex I, 23.1 Interpretation - IFU on the website EU Medical Device Regulations 5
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
S EU MDR CAPA - GAP Assessment on CAPA SOPs EU Medical Device Regulations 1
M MDR Article 22 Interpretation EU Medical Device Regulations 3
A User interface Language Requirements - EU MDR EU Medical Device Regulations 1
L EU MDR Article 86 PSUR EU Medical Device Regulations 1
S How is the service life for class I reusable medical devices described in MDR? EU Medical Device Regulations 7
S How is the service life described for class I reusable medical devices in MDR? Elsmar Xenforo Forum Software Instructions and Help 1
P MDR/IVDR Annex III - Technical documentation on PMS EU Medical Device Regulations 1
E Our company is planning to file MDD not MDR next month. Do we require to show chemical characterization report ? CE Marking (Conformité Européene) / CB Scheme 1
S Classification of a product according to MDR EU Medical Device Regulations 3
L Classification under MDR EU Medical Device Regulations 1
I Interpretation of the MDR GSPR 23.4 (u) EU Medical Device Regulations 2
S Converting SOP MDD to MDR Noob ISO 13485:2016 - Medical Device Quality Management Systems 4
K Biological indicator system classification under MDR EU Medical Device Regulations 2

Similar threads

Top Bottom