Creating the technical file with evidence for UK CA marking

Right Decision Service standard operating procedures
National

The design and manufacture of  DSS developed using the Right Decision Service complies with the requirements of ISO 13485:2016.

All technical documentation for decision support tools developed using the Right Decision Service is prepared in accordance with 93/42/EEC.

This framework for technical documentation has been set out and is compliant with both 93/42/EEC and EU 2017/745 regulatory approval. (It is anticipated that future UK legislation will align with EU legislation with some small deviations).

The technical file, which includes the manufacturer declaration of conformity which is registered with MHRA, is available for inspection by the Competent Authority (MHRA) or its designated UK approved Body.

Technical Documentation is sub-divided into two parts:

Part A:

Summary of essential technical data relevant to conformity assessment procedures

Part B:

Remaining technical documentation

(e.g.  risk analysis, test reports, standards, description of processes etc)

To give some insight into the detail of information provided, the technical file for Polypharmacy Decision Support contains the following information:

1. Introduction

2. Definitions

3. Referenced Documentation

 

4. Part A: Summary of Essential Technical Data

4.1. Name and Address of Manufacturer 

4.2. Identification of Device

4.3 Common or Usual Name

4.4. Device Classification

4.5. Name and Address of Facilities

4.6. Name and Address of Notified Body

4.7. Statement of the Conformity Assessment Procedure

4.8.  Declaration of Conformity

4.9. Brief Description of the Device

4.10. Intended Use

4.11. Label and Instructions for Use

4.12. Statement of Relevant Regulations

4.13. Identification of Technical Standard with which compliance is claimed

4.14. Brief Statement of Bench Testing and Clinical Data Obtained

 

Part B Technical Information

5.1. General

5.2. Technical Documentation

5.2.1. General Description of Device

5.2.2. Intended Use

5.2.3. Operation of Device

5.2.4. Devices incorporating a Medicinal Substance

5.2.5. Device incorporating Nonviable Materials of Animal Origin

5.2.6. Device requiring special consideration

5.2.7. Description of the methods of manufacture envisaged

5.2.8. Associated Equipment

5.2.9. Classification of the device under the relevant Directive

5.3. Technical Requirements

5.3.1. Rationale for Qualification as a Medical Device

5.3.2. Directive which applies to Calculator Suite

5.3.3. Applicable Essential Requirements

5.3.4. Solutions adopted to fulfil the Essential Requirements

5.3.5. Standards Applied

5.4. Design

5.4.1. Software Development Process

5.4.2. Result of Risk Analysis

5.4.3. Specification of Tools and Manufacturing Processes

5.4.4. Specifications

5.4.5. Specification of Production Tests

5.4.6. Performance and compatibilities intended by the manufacturer

5.4.7. Labelling - Instructions for Use

5.4.8. Shelf life reflected by any use-by dates or other lifetime of the device.

5.4.9. Results of bench testing

5.4.10. Clinical Data

5.4.11. Usability

5.4.12. Software

5.5. Administrative Details

5.5.1. Declaration of Conformity

5.5.2. Application for Conformity Assessment 

5.5.3. Declaration that no other Notified Body is used in Conformity Assessment

5.5.4. Notified Body Decisions and Reports

5.5.5. Manufacturer’s undertaking on procedure to review post-production experience

If any DSS software is reclassified and requires third party conformity assessment, this documentation is sufficiently robust to be submitted with minor amendments. This would be undertaken by InnoScot Health as part of on-going certification activities with BSi.