How do I create a Technical File for a Class IIa Medical Device

i started to work for a company that manufactures a Class IIa device. Their existing product (produced before 2006) does not have an existing technical file, but does have a design file.
We are in the process of adding an expanded line to the design file...what do I need to do to create a technical file out of it...or do I need to create a Technical file?
we do sell this product internationally and have a CE NB for it.

A class IIa device does require technical file approval for CE marking. The requirements are in the Medical Device Directive 93/42/EEC with 2007/47/EC amendment. The bulk of your techical file will probably be in addressing the Essential Requirements (usually provided as a table with corresponding harmonized standard and your document/test report). You should ask your notified body for their requirements. I don't know who you use, but the notified body, NSAI, has a requirements document on their web site. You can find it at NSAIinc.com, under medical devices, CE marking, "Documentation Requirements".

sim.s said:

i started to work for a company that manufactures a Class IIa device. Their existing product (produced before 2006) does not have an existing technical file, but does have a design file.
We are in the process of adding an expanded line to the design file...what do I need to do to create a technical file out of it...or do I need to create a Technical file?
we do sell this product internationally and have a CE NB for it.

Click to expand...

Hi and welcome to the cove

As a very general outline, the technical file should include (or reference other documents, such as the design file, that contain) the following:

1. Essential Requirements Checklist
2. Risk Analysis
3. Product Design Drawings and Specifications
4. Chemical, physical and/or biological test reports, as applicable
5. Clinical Evaluation
6. Package Qualification and Shelf life, as applicable
7. Labels
8. Manufacturing processes flow chart, including inspection steps
9. Declaration of Conformity (Draft)

For more detailed guidance refer to the “Recommendation NB-MED/2.5.1/Rec5” document (Co-ordination of Notified Bodies on Council Directive 93/42/EEC).

As well as the very good advice given, when putting together your TF refer to Annex II 3.2 (c,d,e) of the MDD for the structure of a ‘Product Dossier’ section of the TF – this may be similar to your existing design file; it is where you show compliance to the appropriate harmonized standard (if you are using Annex II as your path to conformity that is). This is the approach I have used for class IIa devices – as well as including the other sections as indicated. Don’t forget a section on Usability (to EN 62366 or ISO 60601-1-6). I have also included a reference to the appropriate product group (UMNDS and/or GMDN) as well as sections on ‘Work Instructions’ and ‘Maintenance & Service Schedules’.

I attached a Technical File Index and Essential requirements Checklist in this post which you may find useful.

Are technical files required for chemical agents? I'm not aware of a requirement just want to confirm.
Thanks!