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

S

sim.s

#1
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.
 
Elsmar Forum Sponsor
Q

QualitySage

#2
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".
 

Ronen E

Problem Solver
Staff member
Moderator
#3
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.
Hi and welcome to the cove :bigwave:

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
- Instructions for use
- patient information
- advertising materials
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).
 
S

SteveK

#4
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’.:2cents:
 
Thread starter Similar threads Forum Replies Date
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 6
J Question: How to create an IMDS RoHS, REACH, ELV, IMDS and Restricted Substances 3
M Do we need to create a new CER or can we just update the existing CER EU Medical Device Regulations 3
J Create your own symbol? Other Medical Device Related Standards 7
D How to create IQ, OQ, PQ protocol for existing equipment Other Medical Device Related Standards 2
O How to create robustness checklist from p diagram FMEA and Control Plans 9
T Change control and configuration management - When to create a new model/part number? Other Medical Device and Orthopedic Related Topics 0
R How to create a Work Breakdown Structure? Registrars and Notified Bodies 2
H IMDS for material - Can my Customer create one for my material? RoHS, REACH, ELV, IMDS and Restricted Substances 4
A How do I create a 3^k factorial design with factors be treated as continuous where I Using Minitab Software 0
E How do I create a FMEA for the Internal Audit process? Internal Auditing 11
S Response Surface Method to create design matrix in Minitab Using Minitab Software 5
S Cannot create Rejects for TMV on a medical instrument with an LCD Other Medical Device and Orthopedic Related Topics 10
RoxaneB Carte Blanche to Create an Audit Programme General Auditing Discussions 5
O Is it "legit" to create IMDS before Part Production? RoHS, REACH, ELV, IMDS and Restricted Substances 4
G How to create a mixed OAs in Minitab Using Minitab Software 1
S How to create an Audit Checklist using a Turtle Diagram Internal Auditing 9
A Could I create company specific Employee Records? Records and Data - Quality, Legal and Other Evidence 5
A How to create a Maintenance procedure based on TS 16949 Requirements IATF 16949 - Automotive Quality Systems Standard 5
Ajit Basrur How do I create two different columns in Excel spreadsheet ? Excel .xls Spreadsheet Templates and Tools 5
J Inspection Software to Balloon Drawings and Create First Article Reports Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
T Microsoft Access Database to create a Simple Calibration Certificate General Measurement Device and Calibration Topics 6
J Should a company create different SOPs for ISO14971? ISO 14971 - Medical Device Risk Management 1
J How do you Create SOPs for Multiple Authorities? EU Medical Device Regulations 8
R How to create a pop-up message in Excel Excel .xls Spreadsheet Templates and Tools 18
M What is the formula to create a bell curve? Excel .xls Spreadsheet Templates and Tools 8
M ISO/TS 16949:2009 Follow-up Audit Visits to create more Revenue IATF 16949 - Automotive Quality Systems Standard 12
Q Medical Device with Lead (Pb) - Do I need to create an MSDS sheet? Other US Medical Device Regulations 1
B How to use Minitab to create this Fractional Factorial Design Matrix Using Minitab Software 2
C Document Control using Wiki - Cannot Create all Documents as Wiki Pages Document Control Systems, Procedures, Forms and Templates 10
M How to create the Policy for determining criteria for Risk Acceptability ISO 14971 - Medical Device Risk Management 11
T How create a Fractional Factorial Design with Minitab Using Minitab Software 3
A How to create a Multiple Operations Specifications Comparison Spreadsheet? Excel .xls Spreadsheet Templates and Tools 3
K When to create a new Control Chart? Quick question Statistical Analysis Tools, Techniques and SPC 4
A How to create Drop Down Box in Excel 2007 Excel .xls Spreadsheet Templates and Tools 2
N Asked to create a baseline survey on emails that come in and out of our Office Document Control Systems, Procedures, Forms and Templates 1
J How Do Processes Create Value? Article by Paul Harmon Book, Video, Blog and Web Site Reviews and Recommendations 2
W Requirements Traceability Database - Have one? Help create one? Document Control Systems, Procedures, Forms and Templates 1
S HR Manager refusing to create Quality Objectives - Is this a Non-Conformity? Quality Manager and Management Related Issues 11
C SOP (Standard Operating Procedure) on how to create an SOP Document Control Systems, Procedures, Forms and Templates 6
O Need to Create Macros so that it can copy data to the next row.... Excel .xls Spreadsheet Templates and Tools 5
B Who should create training associated with changes to the procedures? Document Control Systems, Procedures, Forms and Templates 7
J Environmental FMEA - Is it possible to create an environmental FMEA? FMEA and Control Plans 12
C Need help to create tracking tool Excel .xls Spreadsheet Templates and Tools 4
L Customer requirement to create a Guide for defining Control Methods FMEA and Control Plans 9
H How to create Stoplight Control charts with excel? Excel .xls Spreadsheet Templates and Tools 16
W Medical Device FMEA vs. ISO 14971 to create our Hazard Analysis ISO 14971 - Medical Device Risk Management 2
B How Can I Create a Bell curve in Excel 2007 Excel .xls Spreadsheet Templates and Tools 7
H How to create a flow for APQP including design and no including design APQP and PPAP 5
V How to create a CAPA (Corrective Action Preventive Action) Database Nonconformance and Corrective Action 3

Similar threads

Top Bottom