Which class I accessory information should be kept in the Technical File

shimonv

Trusted Information Resource
#1
Hi fellows,
Say you have a class I make item accessory with its own design input/output files. Will you include the detailed accessories information (requirements, V&V, labeling, etc.) in the technical file or just a brief description in the Technical Files and complete details in a separate DHF record?

I believe the second option is correct, but would appreciate hearing what is your experience with NBs.


Thanks,
Shimon
 
Elsmar Forum Sponsor

rob73

looking for answers
#2
We have a separate DHF for accessories, with a document in the main product DFH listing accessories that can be used with the main product and the location of the DHF for that accessory.
 

shimonv

Trusted Information Resource
#3
Thanks Rob, good input.
So following this line of thought - do you have two technical files, one for the device with a brief description of the accessories and one for the accessories?

Thanks,
Shimon
 

rob73

looking for answers
#5
Shimon
Yes, as Ronen points out each devices has to have its own DHF, even accessories. That's not to say you cannot group them if their intended use and design are the same. For instance we manufacture a range of disposables. They vary in size and port configuration but are basically the same device. These are grouped as a product family, the DHF for these references the accessories and their DHF.
 
Last edited:

shimonv

Trusted Information Resource
#6
Thanks Rob and Ronen,
I am adding input from another colleague of mind which should wrap it up:

"If the accessory has its own CE Mark based on its own intended use, then it would have its own technical file since it's a class 1 self-declare.
If the accessory is part of the medical device system/family that is being CE Marked and dependent on the bigger system's intended use, then I would include the information in the bigger technical file."


Best,
Shimon
 

Ronen E

Problem Solver
Staff member
Moderator
#7
If the accessory is part of the medical device system/family that is being CE Marked and dependent on the bigger system's intended use
In that case it might be an accessory in the everyday English meaning but it wouldn't qualify as an Accessory as defined by the MDD.

I was assuming all along we are discussing an Accessory in the MDD meaning.
 
Thread starter Similar threads Forum Replies Date
D Software as an accessory to a Class I medical device EU Medical Device Regulations 4
I Class I Medical Device Accessory with Actual Risk EU Medical Device Regulations 7
Q South Africa Class I Medical Device Accessory Registration Other Medical Device Regulations World-Wide 1
C Compatibility of a Class II exempted accessory with a Class III device US Food and Drug Administration (FDA) 1
D Class I and Class II Medical Device Accessory Design Control Requirements US Food and Drug Administration (FDA) 3
A Class I (exempt) testing requirements Other Medical Device Related Standards 0
Z Class I marketing regulation and supply chain Other Medical Device Regulations World-Wide 0
S We are looking for EU authorised Representative for both Class I and Class IIb devices EU Medical Device Regulations 5
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
R Class 1 Convenience kits for home teeth impression, NOT smile direct or other for alignment purposes Canada Medical Device Regulations 0
J Confusing on Harmonic Emissions/Voltage Fluctuations/Flicker test for CISPR 11 Class A Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
J Intervertebral body fusion cage, MDR Class II or Class III? EU Medical Device Regulations 4
T Do I need a qualified compiler for class B software? IEC 62304 - Medical Device Software Life Cycle Processes 3
R Nanomaterials used as coating on class I MD - rule 19 EU Medical Device Regulations 4
D Amendment Class II - Please confirm if the submission is by email (Canada) - Help Canada Medical Device Regulations 0
D Class IIB Medical Device Accessories - OTS Tablets Other Medical Device Regulations World-Wide 1
K Doubt on insulation class of a device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
D Where to find Guidance Class II Amendment Canada Medical Device Regulations 1
A First CE-mark class III implantable device under MDD EU Medical Device Regulations 8
P ISO Class 8 particle count (annual certification vs monitoring) ISO 13485:2016 - Medical Device Quality Management Systems 4
I IVD - 98/79EC - class IIa - Annex to the EC from the NB states the CM as one of the facilities? CE Marking (Conformité Européene) / CB Scheme 2
Z MDR Class Ir deadline (Reusable surgical instruments) EU Medical Device Regulations 27
D Adding a Class I to a sample box Canada Medical Device Regulations 5
T Class A PRTD beyond 300°C General Measurement Device and Calibration Topics 0
F How to register class I device to all European Competent Autorities(CA) when we are European manufacturer EU Medical Device Regulations 4
K Sterile barrier system symbols - Label redlines for a Class III device (Kit Box) EU Medical Device Regulations 0
D Class 3 Device - Change of supplier of material Canada Medical Device Regulations 6
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W Protective earth for Class I ME equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
K Class III Kit Box - Are translations mandatory under EU MDR? EU Medical Device Regulations 5
Edward Reesor FDA DM and /or Class I Life Saving US Food and Drug Administration (FDA) 0
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
F UDI - Unit of Use and Class I, single-use devices EU Medical Device Regulations 4
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
A AQL - How to count samples with defects for each defect class AQL - Acceptable Quality Level 17
R IVDR CE Mark for Class A products - Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
A Medical Device Vigilance decision tree for Japan for class 2 devices. Japan Medical Device Regulations 1
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
W Seeking Guidance Verification Test Strategy for Class B Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 1
S Shipment of a CE Approved Class III Device to the EU Member States Other US Medical Device Regulations 1
S Technical File for Surgical Mask in Class 1 MDD Elsmar Cove Forum ToS and Forum Policies 1
Edward Reesor EU Authorized Representative for a Class I Medical Device CE Marking (Conformité Européene) / CB Scheme 11
S Class I MDR Article 10 – QMS EU Medical Device Regulations 1
Q Old products new class - Dental Devices - Choosing tests EU Medical Device Regulations 2
dinaroxentool Former Class I device that is upscaled to IIa if the MDR is delayed EU Medical Device Regulations 2
J Class Fixed ME Equipment (US Deviation) IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
W Direct to customer export of medical device (class I: prescription lenses + frame) US Food and Drug Administration (FDA) 2
M CE self-certification for Class I device (face mask) EU Medical Device Regulations 9
C New Class III medical device application for Health Canada Canada Medical Device Regulations 6

Similar threads

Top Bottom