Classification Rationale for class 1

#1
We were told to develop a classification rationale for our class 1 non invasive medical devices that we did not feel were class 1 r . Does anyone have any sort of template to help write this?
 
Elsmar Forum Sponsor

KShaw

Starting to get Involved
#2
Hi Karena,

I cannot really guide you towards a particular template, but what I would suggest is that you list the Rules for Annex VIII of the MDR in a table. Near each one, you identify which are applicable, and which are not, providing a rationale for each. You can obviously group many at once (e.g. you say it is not invasive, so rules 5-8 won't apply).

With respect to identifying whether it will qualify as 1r or not, again copy the definition of a reusable surgical instrument as provided in Annex VIII and provide your rationale as to why your product does not fit that definition.

If you haven't already, you're also supposed to provide a rationale as to why your product qualifies as a medical device under the MDR.

Hope this helps!
 

Highground

Involved In Discussions
#3
This is the basic format we are using. It will give you an idea how to set the document up.

I need help on accessories that are classified as Class I for use with a system that is Class IIb which is approved under MDD until 2024. Do I have to classify the class I under MDR?
 

Attachments

KShaw

Starting to get Involved
#4
Hi Highground,

If your products truly meet the definition of an accessory to a medical device, then they will be treated as a medical device in their own right. Furthermore, if they are not considered to be part of the Class IIb system (and thus have not been assessed by an NB) you would be expected to meet the MDR requirements for this Class I accessory and meet the MDR manufacturer's obligations. Just be careful of the 26 May 2021 deadline.
 
Thread starter Similar threads Forum Replies Date
S Please explain Medical Device Product Classification Rationale 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Revising Declaration of Conformity and Classification Rationale EU Medical Device Regulations 2
Z Example of a Classification Rationale Statement CE Marking (Conformité Européene) / CB Scheme 3
B Classification of screening system EU Medical Device Regulations 14
T FDA level of concern vs IEC 62304 safety classification - 510(k) exempt device Other US Medical Device Regulations 12
L SBS - CLASSIFICATION Medical Device and FDA Regulations and Standards News 2
T Software item classification and Detailed Design IEC 62304 - Medical Device Software Life Cycle Processes 4
T Classification Accessory Software medical device EU Medical Device Regulations 4
W AR and Device Classification EU Medical Device Regulations 2
C Classification - "Metabolic Means" EU Medical Device Regulations 5
G Software Medical Device Classification EU Medical Device Regulations 7
D MDR classification and DoC requirements Medical Device and FDA Regulations and Standards News 3
R Reusable Needle Guide Classification EU Medical Device Regulations 0
P Identifying GAMP Classification: GAMP 4 or GAMP 5 ISO 13485:2016 - Medical Device Quality Management Systems 1
S Classification of product (measuring or not?) CE Marking (Conformité Européene) / CB Scheme 5
F Product classification according to the 60601-2-57: Particular requirements [...] of non-laser light sources [...] IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
C Question on KAFO (Knee Ankle Foot Orthosis device) classification CE Marking (Conformité Européene) / CB Scheme 0
SANTHSH Consumables, Paints, End-covers, NDE Chemicals & Tools suppliers classification and evaluation Oil and Gas Industry Standards and Regulations 6
G Classification of a container containing a liquified gas EU Medical Device Regulations 0
dgrainger Informational MDCG 2021-24 - Guidance on classification of medical devices EU Medical Device Regulations 0
B Nasal Saline Solution for Irrigation purpose classification EU Medical Device Regulations 0
S Classification of a Sterile Procedure Pack EU Medical Device Regulations 0
P Device Classification CE Marking (Conformité Européene) / CB Scheme 0
B IVDR Classification and accreditation CE Marking (Conformité Européene) / CB Scheme 0
R IEC 60601-2-57 light source classification IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
N Cleanroom Classification Change Other Medical Device Related Standards 7
M Classification of Instruments under EU MDR EU Medical Device Regulations 1
P Blood establishment computer software EU classification EU Medical Device Regulations 0
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 5
C MDR Classification Rule 10 EU Medical Device Regulations 16
C MDR software classification EU Medical Device Regulations 12
K Question on MDR classification EU Medical Device Regulations 5
L Programmer accessories classification EU Medical Device Regulations 0
R ELISA reader - IVDR classification EU Medical Device Regulations 9
F FDA classification for a mobile app Medical Information Technology, Medical Software and Health Informatics 3
D Classification of product for clinical trials EU Medical Device Regulations 14
A IEC 62304 safety classification, External Controls and off-label use related risks IEC 62304 - Medical Device Software Life Cycle Processes 5
R Classification of USB DC operated medical equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Surgical Instrument Tray Classification EU Medical Device Regulations 7
S Classification of a product according to MDR EU Medical Device Regulations 3
L Classification under MDR EU Medical Device Regulations 1
shimonv Classification of a cloud- base viewer for the output from a medical device US Food and Drug Administration (FDA) 7
K Biological indicator system classification under MDR EU Medical Device Regulations 2
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
dinaroxentool Question about FDA Classification of a Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
N What is our product classification? (Does Unclassified classification still exists) Other US Medical Device Regulations 14
nadhar2 Classification of Action Items Misc. Quality Assurance and Business Systems Related Topics 3
A Class medical device (MDD) - Classification help EU Medical Device Regulations 1
D IEC 62304 Risk Classification - With and without hardware control IEC 62304 - Medical Device Software Life Cycle Processes 2
M Classification of Clean Rooms Other Medical Device Related Standards 9

Similar threads

Top Bottom