Technical File for Medical Device Accessories

Q

QA_RA

#1
Hello!

I'm relative new to the regulatory industry, I've recently completed a Technical file for my company's device. My manager requested another Technical file only for the accessories.

I'm not sure where to how to start a technical file for only medical accessories. Are there tech files made only for accessories?

Thank you in advance for your help!
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#3
Hello!

I'm relative new to the regulatory industry, I've recently completed a Technical file for my company's device. My manager requested another Technical file only for the accessories.

I'm not sure where to how to start a technical file for only medical accessories. Are there tech files made only for accessories?

Thank you in advance for your help!
Accessories in there own right are also medical devices when placed in market independently. They will carry a device label and your technical file for this will be pretty much on the same lines as the device itself, just scaled down to the requirements of the specific accessory.
As you have a completed file for the device, it must be no great challenge to put in place one for the accessory.
 

SteveK

Trusted Information Resource
#4
No problem with what Somashekar has indicated. I would just point out to your manager that TFs require reviewing by NBs. The more TFs, the more the individual review cost. In our case the last TF review cost circa $3000.:2cents:

Steve
 
Thread starter Similar threads Forum Replies Date
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 1
O Medical Device Technical File Confidentiality - On site reviews EU Medical Device Regulations 14
J One Medical Device, two indications, two classes, one technical file? EU Medical Device Regulations 3
A Technical file requirement for Class IIb medical device CE Marking (Conformité Européene) / CB Scheme 3
J Update Technical File for EU Class IIa Medical Software Products EU Medical Device Regulations 3
M Technical File Locations - Class I and Class IIa Medical Devices EU Medical Device Regulations 3
E When to submit a Technical File for a Class IIb Medical Device EU Medical Device Regulations 3
L Labeling Requirements in Part A Class IIb Medical Device Technical File CE Marking (Conformité Européene) / CB Scheme 2
T Class IIa Medical Device Technical File - Annexes EU Medical Device Regulations 6
O Medical Device Registration in EU - Which Ministry to submit Technical File? EU Medical Device Regulations 9
M Medical Device Technical File SOP example available? EU Medical Device Regulations 14
S What constitutes a Medical Device Technical File "Family?" EU Medical Device Regulations 6
rob73 Transfer of Technical File, CE Mark etc., for an OEM Medical Device EU Medical Device Regulations 3
L Class 1 Medical Device Contract Manufacturer Technical File Requirements Design and Development of Products and Processes 3
SteveK How big is your Medical Device Technical File? CE Marking (Conformité Européene) / CB Scheme 3
SteveK Medical Device Technical File/Dossier (CE Mark) review - How many ?experts? available CE Marking (Conformité Européene) / CB Scheme 3
C Class II Medical Device Technical File Checklist CE Marking (Conformité Européene) / CB Scheme 20
rob73 Technical File Information on Moulded Parts of a Medical Device EU Medical Device Regulations 5
M Medical Device Testing Based in Manchester? Consultant to open Technical File EU Medical Device Regulations 4
S How do I create a Technical File for a Class IIa Medical Device EU Medical Device Regulations 4
SteveK Technical File Submission? - Medical Devices no longer made EU Medical Device Regulations 10
M Documentation of OEM Device - Technical File for a Class IIa Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 4
SteveK Technical File Review to updated MDD 93/42/EC (Class II medical devices) EU Medical Device Regulations 3
A CE Marking Basics - Medical Laser - Compiling the Technical File ISO 13485:2016 - Medical Device Quality Management Systems 8
J Technical File vs. Design Dossier - Class II and Class III Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 12
S Requirements for Updating a Medical Device Technical File EU Medical Device Regulations 11
S Technical File for Surgical Mask in Class 1 MDD Elsmar Cove Forum ToS and Forum Policies 1
A Technical File - Updating Applied Standards EU Medical Device Regulations 4
M What to be careful about/focus on when doing a Technical File review EU Medical Device Regulations 4
Watchcat Anyone had an MDR technical file review/audit yet? EU Medical Device Regulations 13
G Same intended use devices - Technical file EU Medical Device Regulations 2
F Management of Software version while NB reviews Technical file CE Marking (Conformité Européene) / CB Scheme 7
D Risk Analysis & Technical File - What detail goes in the Risk Management Report ISO 14971 - Medical Device Risk Management 5
N Technical file requirements class 1 device MDR Other Medical Device Regulations World-Wide 6
N How to Write and Compile a Technical File for CE Marking CE Marking (Conformité Européene) / CB Scheme 4
N Technical File Reviewer has requested more testing to ISO 10993 Other Medical Device Related Standards 10
M Technical File (STED) labelling - When you compile tech files do we have to include all the product labels? EU Medical Device Regulations 2
S MDR Technical File Structure Requirements EU Medical Device Regulations 12
D MDD to MDR - Technical File conversion EU Medical Device Regulations 4
J Connection between Technical File and Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
TechnicalGuy Technical File Review - Transfer to a new NB EU Medical Device Regulations 3
D Technical file structure/content requirements for Class IIa devices & new MDR EU Medical Device Regulations 14
T IVD - Self Declaration - Technical File - Template wanted Various Other Specifications, Standards, and related Requirements 9
T Technical File - Previous Device Generations EU Medical Device Regulations 2
K Questions on Technical File to show it is current EU Medical Device Regulations 5
Sam Lazzara Expedited, fast-track Notified Body Technical File reviews EU Medical Device Regulations 3
S Question about Australia - TGA and MDSAP - Technical file ISO 13485:2016 - Medical Device Quality Management Systems 3
A Technical File Procedure (for Company) - Example wanted EU Medical Device Regulations 1
C Technical File Assessment from a NB - Clinical Equivalence CE Marking (Conformité Européene) / CB Scheme 6
M Merge Technical File, DMR, and Device File into a single document? Other Medical Device and Orthopedic Related Topics 3
Similar threads


















































Top Bottom