Technical documentation for IVDD General/ other

#1
Hi everyone. We have a nucleic acid extraction instrument and wanna get it CE-marked.
I've been reading Annex III to 98/79/EC and I fail to understand the exact technical files required for CE-marking...
Has there anyone had similar registration experience?
Anyone could advise me on what guidance I should look up to?
Appreciated!
 
Elsmar Forum Sponsor

chris1price

Trusted Information Resource
#2
98/79/EC Annex III is pretty straight forward, section 3 lists all the documentation you need to compile. I would set up a file with headings matching the bullets then fill in the information. If you don't have what is requested, then you need to start doing the necessary work.

However..... you are less then 12 months away from the new IVD regulation. This will almost certainly require review of your files by a notified body. I would strongly recommend working towards meeting that regulation rather than the IVDD.
 
#3
98/79/EC Annex III is pretty straight forward, section 3 lists all the documentation you need to compile. I would set up a file with headings matching the bullets then fill in the information. If you don't have what is requested, then you need to start doing the necessary work.

However..... you are less then 12 months away from the new IVD regulation. This will almost certainly require review of your files by a notified body. I would strongly recommend working towards meeting that regulation rather than the IVDD.
Thanks Mr.Chris Price. The instrument falls into Class A under IVDR so no NB would be involved.
So I will just compile technical files and a DoC and send them to European Representative then I can affix a CE mark, right?
 

chris1price

Trusted Information Resource
#4
Essentially, you are correct, for a class A product you complete the technical documentation and CE Mark your device. However, take a look at Annex II and III of the IVDR, there are a lot of requirements there, it is much more than needed for IVDD. I also suggest including a good rationale for why your device does not fall under Rule 3i as a device for genetic testing and be Class C.
 
Thread starter Similar threads Forum Replies Date
A Technical documentation ce marking pippete tips CE Marking (Conformité Européene) / CB Scheme 0
S Medical Device - Technical Documentation structure EU Medical Device Regulations 1
I "Usability" for technical documentation EU Medical Device Regulations 1
H MD Technical Documentation and SALES possibility EU Medical Device Regulations 0
A DMDIV-Variants : definition and technical documentation CE Marking (Conformité Européene) / CB Scheme 4
P MDR/IVDR Annex III - Technical documentation on PMS EU Medical Device Regulations 1
I Maintaining Technical Documentation under MDD and MDR EU Medical Device Regulations 1
M Basic UDI and technical documentation EU Medical Device Regulations 1
C Maintenance of Product Technical Documentation EU Medical Device Regulations 3
C Access to Technical Documentation - MDR Chapter VI Article 61 EU Medical Device Regulations 4
N EU MDR Basic UDI-DI and Technical Documentation for Systems EU Medical Device Regulations 22
I MDD Class I software technical documentation sample EU Medical Device Regulations 2
M Annex II - Technical Documentation. V&V, Performance and Safety EU Medical Device Regulations 3
D MDR and Summary Technical Documentation Files EU Medical Device Regulations 18
B Gap analysis of new start-up company technical documentation CE Marking (Conformité Européene) / CB Scheme 1
A Technical Documentation - Manufacturing Specifications EU Medical Device Regulations 4
J Technical Documentation Review: Responding to a Nonconformity ISO 13485:2016 - Medical Device Quality Management Systems 14
J Software for maintaining of Technical files and medical device documentation(RA need) Medical Information Technology, Medical Software and Health Informatics 2
F Technical File - RoHS2 Technical Documentation RoHS, REACH, ELV, IMDS and Restricted Substances 2
Q Use of standard references in documentation (PRS, Technical File) Document Control Systems, Procedures, Forms and Templates 1
T Information and Structure for Technical Documentation for Firmware ISO 13485:2016 - Medical Device Quality Management Systems 1
A ISO 16016 - Technical product documentation Other ISO and International Standards and European Regulations 2
S Translation Software for Documentation with Technical Words - Recommendations wanted Quality Tools, Improvement and Analysis 5
S Medical Device Technical Files (Class IIa & IIb) ? Design Development Documentation EU Medical Device Regulations 7
M Documentation of OEM Device - Technical File for a Class IIa Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 4
Le Chiffre Health Canada to accept Summary Technical Documentation (STED) for Class III & IV ISO 13485:2016 - Medical Device Quality Management Systems 1
C Technical Documentation, DMR, ISO 13485 vs. FDA, STED Document Control Systems, Procedures, Forms and Templates 10
C Structure and Content of DMR / Technical Documentation (FDA vs. ISO 13485)? Document Control Systems, Procedures, Forms and Templates 6
A Technical Documentation Records - Customer drawing, Revision Level, PPAP, etc. Document Control Systems, Procedures, Forms and Templates 1
D Technical Documentation Package (TDP) - Listing of the types of documents contained Document Control Systems, Procedures, Forms and Templates 4
M Does anyone know of a forum that discusses Technical Documentation? Document Control Systems, Procedures, Forms and Templates 4
B MDR Technical Structure EU Medical Device Regulations 3
LostLouie Archived Specifications and Drawings for Medical Device Technical Files EU Medical Device Regulations 2
D Notified Bodies - ISO 13485 & MDR Technical Files ISO 13485:2016 - Medical Device Quality Management Systems 3
C European Technical File for registration in Australia CE Marking (Conformité Européene) / CB Scheme 5
K Technical file for MHRA - looking for assistance with self declaration Class I device CE Marking (Conformité Européene) / CB Scheme 8
O Soft and technical skills for a VP of Quality Career and Occupation Discussions 1
A CE-IVD Technical File with Multiple IFUs EU Medical Device Regulations 4
M Office and manufacturing site relocation effect on Device Technical File CE Marking (Conformité Européene) / CB Scheme 2
R MDR & depth of technical files review by NB's EU Medical Device Regulations 18
J Saudi Arabia Technical File Requirements Other Medical Device Regulations World-Wide 1
DuncanGibbons Technical Data Package vs Digital Product Definition APQP and PPAP 0
D Hospital Decontamination and the MDR - Technical Files, UDI and PMS EU Medical Device Regulations 3
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 3
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 5
B Clause 5.1.12 of Technical Standard IEC 62304/A1 IEC 62304 - Medical Device Software Life Cycle Processes 5

Similar threads

Top Bottom