UKCA Technical File Submission Guidance

Instructions / Guidance

The Technical Files will be covered under the UK MDR 2002 Regulations.

This UKCA guidance document covers the compilation of Technical Files as part of the UKCA certification process. The Technical
Files will be covered under the UK MDR 2002 Regulations.

Definitions:

MTF – Master Technical FIle

MDD – Medical Device Directive
UK MDR – UK MDR 2002 Regulations (as amended)
SOP – Standard Operating Procedure
eDMS – Electronic Document Management System

Collation of UKCA Technical Files

The UKCA Technical File is prepared in accordance with the requirements of UK MDR 2002 Regulations and NB-MED/2.5.1
Technical Documentation guidance.

Master Technical File

The Master Technical File (MTF) is used as a single source file from which Technical Documentation is obtained to create a UKCA
Technical File. The MTF can be obtained via the CooperVision eQMS (Agile) and be filtered via base product.

Documents will be retrieved from the confirmed base product corresponding to the Technical File being compiled. This will include
the STED and all applicable supporting information.

UKCA Technical Documentation folder structure

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Electronic folders are created within the EMEA RA network drive to store supporting documentation. Please see example
screenshot below folder structure for compilation of UKCA Technical Documentation.

UKCA Essential Requirements / Standards

Essential Requirements as per UK MDR 2002 Regulations Annex I

(UKCA) should refer to British Standards (where applicable).
Therefore, the Technical File and Declaration of conformity for
UKCA mark should use the British national BS pre-fix, for example
BS EN ISO 13485.

Designated standards list available in support of UK MDR 2002

Regulations can be found below:

Designated standards: medical devices - GOV.UK (www.gov.uk)

Declaration of Conformity

The object of the declaration prescribed within the Declaration of Conformity will be to UK MDR 2002 Regulations.

Standards referenced within the Declaration of Conformity should reference British Standards (where applicable).

UKCA Technical File Checklist

Requirements: Available:
Part A – Technical Documentation / Design Dossier
1 Table of Contents ☐

2 Introduction ☐
1. Manufacturer name and address
2. Regulatory Information (UKAB, GMDN, Product marketing history, Conformity assessment route etc.)
3. File date and issue number
3 Design Dossier ☐
Comprehensive description of the device with a summary of all associated design information
Part B - Annexes
1 Essential Requirements Checklist
☐
Annex I Essential Requirements UK MDR 2002
2 Risk Analysis ☐
Risk Management Plan, Risk Management Report, Product Risk Assessment
3 Drawings, Design, Product Specification ☐
Material Composition, Packaging Information, Device Specifications
4 Chemical, Physical, Biological Tests
☐
Biocompatibility Data, Microbiology, Performance Testing and Storage Conditions
5 Clinical Data ☐
Clinical Evaluation Report, Clinical Evaluation Plan, Biological Evaluation Plan
6 Labels, Instructions for Use ☐
All layers of Labelling and Instructions for Use.
7 Manufacturing
☐
Manufacturing flowcharts, Supplier Controls, Environmental control
8 Packaging, Qualification, Shelf Life ☐
Packaging, Shelf life and Validation Reports
9 Sterilisation ☐
Sterilisation Validation Reports
10 Measuring Function
☐
Statement on whether measuring function is applicable/not applicable
11 Combination Device (Medical Devices) ☐
Statement on whether Combination Device is applicable/not applicable

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 12 Compatibility with Medicinal Devices
☐
Statement on whether compatibility with Medicinal Devices is applicable/not applicable
13 Other Applicable Directives and Regulations ☐
Standards list of all applicable directives/regulations
14 Conclusion ☐
Conclusion summary (Design, Risk Benefit profile of device)
15 Declaration of Conformity
☐
UK MDR 2002 Regulations

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