1

Document (Including Technical File) Maintenance Policy, including · Notification of significant changes and · Controlled Document and Quality Record retention periods

2

Intended Purpose

3

Documented Classification and Attestation Route

4

Manufacturing & Full QA specification Index (DMR)

5

Product Description, including Variants and Accessories

6

Performance Claims + Indications

7

Device Life defined with rationale/ supporting data

8

List of Standards applied in Full or Part

9

Essential Requirements checklist

10

List of Design Input Specified Requirements and results of Design Verification

11

Results of Risk Analysis as part of Risk Management

12

Labelling Spec + Sample of Labelling + control procedure

13

Instructions for Use

14

Clinical Evaluation Data to Support # 6 above

15

Policy commitment and Procedure covering Post Sales Vigilance, Post Market Feedback, Product Recall & issue of Advisory Notices and Complaint Handling

16

Declaration of Conformity including Product Schedule

17

Notified Body intervention if Class IIa or higher or Class I Sterile or Measuring Function

18

Registration with Competent Authority if Class I Self Certification, Custom Made or Article 12 devices

19

Appointment of an Authorised Representative and Registration with Competent Authority if outside Europe

20

Procedures

21

Forms

22

Risk Analysis Form