DOCUMENTS

Medical Device Certification MDR

M.FR.07.01 – Application Form

M.FR.07.04 – MDR Certification Flowchart

M.FR.08.15 – Planned Change Notification Form

M.FR.09.01 – Planned Change Control Form Before Surveillance Audit

M.FR.19.01 – Confidentiality Declaration

M.FR.20.01 – Impartiality Declaration

M.FR.23.02 – Certification Rules and General Conditions

M.FR.23.03 – Product Information Receipt Form

M.FR.24.01 – Customer Complaint Objection and Advice Form

M.PR.07 – Receiving & Evaluating Certification Pre-Applications Procedure

M.PR.10 – Suspension, Scope Reduction & Withdrawal of Certificates and their Notification Procedure

M.PR.11 – Change of Certification Body-Notified Body Procedure

M.PR.21 – Certificate and Brand Usage Procedure

M.PR.22 – Audit Duration Determination and Planning Procedure

M.PR.23 – Audit Fee Determination Procedure

M.PR.24 – Appeals and Complaints Evaluation Procedure

M.PR.27 – Control of Subcontractors Activities Procedure

M.PR.31 – Remote Audit Procedure

M.PR.32 – Safety Procedure for Pandemic

M.PR.35 – MDR Certification Procedure

M.TB.22.01 – EU 2017-745 MDR Technical Documentation Review Durations

M.1B.22.02 – EU 2017-745 MDR Review Durations — Class Is-m-r

M.1B.23.01 – Certification Fees

M.1B.35.01 – Certification Programme Table

M.TL.07.01 – Pre-Application Instructions

Medical Device Certification MDD

FR.07.01 Application Form

FR.08.15 Change Notification Form

FR.19.01 Confidentiality Declaration

FR.20.01 Impartiality Declaration

FR.23.02 Certification Rules & General Conditions

FR.24.01 Customer Complaint Objection and Advice Form

ISO 17021 Accreditaion Certificate

PR.07 Receiving & Evaluating Certification Applications Procedure

PR.08 Certification Procedure

PR.09 Surveillance & Other Audits Procedure

PR.10 Certificates Suspention, Withdrawal & Notification Procedure

PR.11 Change of CB & NB Procedure

PR.21 Certificate & Brand Usage Procedure

PR.22 Audit Duration Determination & Planning Procedure

PR.23 Audit Fee Determination Procedure

PR.24 Appelas & Complaints Evaluation Procedure

PR.25 Certification Committee Work Procedure

PR.27 Control of Subcontracted Audit Activities Procedure

PR.31 Remote Audit Procedure

PR.32 Safety Procedure For Pandemic

TL.09.01 Significant Changes Indicated in Transitional Provision Defined in the Scope of MDR Article 120

TL.23.01 Instruction on the Implementation of the Provisions of (EU) 2023/607