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Controlled public information

Resources and documents

Published forms, procedures and guidance are presented with language, document code, revision and status. Superseded material is clearly identified rather than silently replaced.

Controlled medical-device packaging and production records with technical orange contours
01

Application resources

Current application guidance and declarations are linked to the applicable digital workflow.

02

Certification information

Understand assessment routes, obligations, surveillance and certificate status controls.

03

Regulatory updates

NOTICE publishes relevant changes and effective dates with clear source references.

Controlled publication register

Public document library

Published documents are QMS-approved and checksum-verified.

Publication control MDD content labelled “Legacy / transitional” is not current MDR guidance.

EN

MDD legacy/transitional

FR.19.01 Confidentiality Declaration

Code
FR.19.01
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
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EN

MDD legacy/transitional

FR.20.01 Impartiality Declaration

Code
FR.20.01
Revision
Not stated in source
Language
EN
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EN

MDD legacy/transitional

FR.23.02 Certification Rules & General Conditions

Code
FR.23.02
Revision
Not stated in source
Language
EN
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Not stated in source
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EN

MDD legacy/transitional

FR.24.01 Customer Complaint Objection and Advice Form

Code
FR.24.01
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
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SHA-2563ac7096ac0bc7d09d371173c9dacb5c57e6d8a49979617178250c7869f112dd1

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EN

MDD legacy/transitional

ISO 17021 Accreditaion Certificate

Code
Not assigned in source
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
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EN

MDD legacy/transitional

M.FR.08.15 - Planned Change Notification Form

Code
M.FR.08.15
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
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EN

MDD legacy/transitional

PR.09 Surveillance & Other Audits Procedure

Code
PR.09
Revision
Not stated in source
Language
EN
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Not stated in source
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EN

MDD legacy/transitional

PR.23 Audit Fee Determination Procedure

Code
PR.23
Revision
Not stated in source
Language
EN
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Not stated in source
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EN

MDD legacy/transitional

PR.10 Certificates Suspention, Withdrawal & Notification Procedure

Code
PR.10
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
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EN

MDD legacy/transitional

PR.11 Change of CB & NB Procedure

Code
PR.11
Revision
Not stated in source
Language
EN
Effective date
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EN

MDD legacy/transitional

PR.21 Certificate & Brand Usage Procedure

Code
PR.21
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
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Not recorded in source
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EN

MDD legacy/transitional

PR.22 Audit Duration Determination & Planning Procedure

Code
PR.22
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
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Not recorded in source
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SHA-2561d38d6391749051b836acedc0eba601befcbb90d10a2ad714230b8674453b9a5

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EN

MDD legacy/transitional

PR.24 Appelas & Complaints Evaluation Procedure

Code
PR.24
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
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Not recorded in source
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EN

MDD legacy/transitional

PR.25 Certification Committee Work Procedure

Code
PR.25
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
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EN

MDD legacy/transitional

PR.27 Control of Subcontracted Audit Activities Procedure

Code
PR.27
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
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Not recorded in source
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EN

MDD legacy/transitional

PR.31 Remote Audit Procedure

Code
PR.31
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
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Not recorded in source
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EN

MDD legacy/transitional

PR.32 Safety Procedure For Pandemic

Code
PR.32
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
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SHA-2562001e99e429e64171360a40ae16fa8c2539b42459fd7cf087fc4c083afabbace

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EN

MDD legacy/transitional

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

Code
TL.09.01
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
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SHA-2565ef4db82167eb54a3105b82e4dbbfb10a004c362743fd64b6e0b389ab74f40cf

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EN

MDR

ISO 17021 Accreditaion Certificate

Code
Not assigned in source
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
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SHA-25618e0029681d1615bde77293a69fa0c491476f5599888b9c064449512ea10bfc8

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EN

MDR

M.FR.07.01 - Application Form

Code
M.FR.07.01
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
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Not recorded in source
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SHA-256023f9106b7a4e7a395430f788870be0df850c539c78cd3ffa03fe056effbc94d

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EN

MDR

M.FR.07.04 - MDR Certification Flowchart

Code
M.FR.07.04
Revision
Not stated in source
Language
EN
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Not stated in source
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SHA-2562aa1e8616304d0c22991c24db850121a101d721951c68bd4d78eaaeaf4f71d45

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EN

MDR

M.FR.07.07 - Structured Dialogue

Code
M.FR.07.07
Revision
Not stated in source
Language
EN
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Not stated in source
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EN

MDR

M.FR.08.15 - Planned Change Notification Form

Code
M.FR.08.15
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
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SHA-25623c0aa832467a7a40c32d5109b4b0fb553489f1bff267052844ff98b42fa68f4

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EN

MDR

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

Code
M.FR.09.01
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
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EN

MDR

M.FR.19.01 - Confidentiality Declaration

Code
M.FR.19.01
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
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SHA-2565b91947d2fcb9310f797f92728eccbb966da6276576623c1cc8460ad5ffd9c30

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EN

MDR

M.FR.20.01 - Impartiality Declaration

Code
M.FR.20.01
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
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Not recorded in source
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SHA-256ef8a54d914820e3ebb5e694c94f258404ef037b50754955877acc17d15b0d071

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EN

MDR

M.FR.23.02 - Certification Rules and General Conditions

Code
M.FR.23.02
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
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EN

MDR

M.FR.23.03 - Product Information Receipt Form

Code
M.FR.23.03
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
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SHA-25650fcc7c2bd546452a2eb1bd3afa13f71651d56d994e61bd9d15846bbad0a8bfb

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EN

MDR

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

Code
M.FR.24.01
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-256667d833ea0f934e70b94e31446ef038a8be357ad1a49e73130af8956b9af21f1

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EN

MDR

M.FR.36.01 - Application Form – Importers & Distribitors

Code
M.FR.36.01
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-256389d17a4e896c23d2e25eb75f6590f9505b16f58ddab2fea30ac673c68d22500

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EN

MDR

M.FR.36.03.b - Certification Rules and General Conditions - Importers & Distribitors

Code
M.FR.36.03.B
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
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SHA-256ad7695161f3d1da8d58d677fa2dd078ede515739fb4a34b6e6ed84d923bcd054

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EN

MDR

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

Code
M.PR.07
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
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SHA-2567b854963b0c3b518a8128e5bbfccb39a9b3890bc7a7f8978c80baffab06652b9

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EN

MDR

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

Code
M.PR.10
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
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SHA-2567f74b95c590ae831c333f0c39af8fcb321e51742eea32f2b515e19cb45cbe769

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EN

MDR

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

Code
M.PR.11
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
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SHA-2568343ee691b4f24cbb641a5d1d7af40aa271adf12df14ec4bab5655534f60f52a

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EN

MDR

M.PR.21 - Certificate and Brand Usage Procedure

Code
M.PR.21
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-2564041f25d352d453c9ff935b75c2de8bccdfbb0e03e66e9dad1f6f972fe291dc3

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EN

MDR

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

Code
M.PR.22
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-25686bd3c3085cc0eafdbd7a0ec744a35c0ce755a6e6cc3c5dc1900f476738db03e

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EN

MDR

M.PR.23 - Audit Fee Determination Procedure

Code
M.PR.23
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-256c79b4b45357d3af21e39442651f8aced6fe7ed584a02e501971222a9f5d276b8

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EN

MDR

M.PR.24 - Appeals and Complaints Evaluation Procedure

Code
M.PR.24
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-25676a55505438b36f3d2ec62292522ecf6134a8de8fa12838b045c905c170500fb

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EN

MDR

M.PR.27 - Control of Subcontractors Activities Procedure

Code
M.PR.27
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
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Not recorded in source
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SHA-256ee43437ea84dddc92c56fce0777002611ce831aa4086e613e643778379fa2ed5

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EN

MDR

M.PR.30 - Advertisement and Promotional Activities Procedure

Code
M.PR.30
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-25692afd34a30d0a4971dcd51bead855d5417cd3d2225b5e25943c8f70ba13fa639

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EN

MDR

M.PR.31 - Remote Audit Procedure

Code
M.PR.31
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-256c4c2fba644763d817bef85fac0d93a33605ab433917d955a867be02cafdce9f5

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EN

MDR

M.PR.32 - Safety Procedure for Pandemic

Code
M.PR.32
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
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SHA-256a5c27ef8012281310b4799fb4b071d9e1c47e7e9c2bca68343271f5ec628c335

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EN

MDR

M.PR.35 - MDR Certification Procedure

Code
M.PR.35
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
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Not recorded in source
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SHA-2569494daa84745b5ddb5678b299740bc0c758685e6b10d18f31975fa4152f4ab59

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EN

MDR

M.PR.36 - Distributors and Importers Certification Procedure

Code
M.PR.36
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-25699ced74969fcbc83d9feb6de0ca2075e3b37a348157a4756f08ff137530ef5d3

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EN

MDR

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

Code
M.TB.22.01
Revision
Not stated in source
Language
EN
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Not stated in source
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SHA-256a19f1b08feb0782f3150c1dfda14f530893f3b30a7f2fd4764dc21434d055904

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EN

MDR

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

Code
M.TB.22.02
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
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SHA-2560d840f88c25083e0ff7c7eafc76fab8277d812e865f1601364b97566dff40588

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EN

MDR

M.1B.23.01 - Certification Fees

Code
M.TB.23.01
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
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SHA-2566708cb2970428082b87ab869c2c781b832a9929694f1a89fc5f9626d720e4d06

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EN

MDR

M.1B.35.01 - Certification Programme Table

Code
M.TB.35.01
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
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Not recorded in source
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SHA-25613cd090c62120c7c5b4af80ee27a4018887d4be0985c1d965133961930379830

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EN

MDR

M.TL.07.01 - Pre-Application Instructions

Code
M.TL.07.01
Revision
Not stated in source
Language
EN
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Not stated in source
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Not recorded in source
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SHA-25632a1533ca8a94e2b3c8be4296124d460594f189b7bb2c0598e1c613f3b2b2e90

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EN

MDR

M.TL.07.04 - Exceptional Circumstances Instruction for Legacy Devices

Code
M.TL.07.04
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
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SHA-256906a9a2e9068241258f092e1715e92285ac458508412fd6b3fc18ad5008995a8

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EN

ISO 13485 QMS

ISO 17021 Accreditaion Certificate

Code
Not assigned in source
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
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Not recorded in source
File integrity and source

SHA-25618e0029681d1615bde77293a69fa0c491476f5599888b9c064449512ea10bfc8

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EN

ISO 13485 QMS

M.FR.07.01 - Application Form

Code
M.FR.07.01
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-256023f9106b7a4e7a395430f788870be0df850c539c78cd3ffa03fe056effbc94d

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EN

ISO 13485 QMS

M.FR.07.03 – ISO 13485 Certification Flowchart

Code
M.FR.07.03
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
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SHA-256d225b2dc100b6de909fe9c9058a165b3c7fd7b5bf1c8358494075aa2c2f6ddf4

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EN

ISO 13485 QMS

M.FR.08.15 - Planned Change Notification Form

Code
M.FR.08.15
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-2561f9d41b4e33478e4471f10a49c5c3359d9efcd5f0d8bc94c7df17a1253508be8

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EN

ISO 13485 QMS

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

Code
M.FR.09.01
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-25634fc03285fc62b71fdac7aa6c5466e99ba74eebc40dce61f8623cbadc5fecdad

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EN

ISO 13485 QMS

M.FR.19.01 - Confidentiality Declaration

Code
M.FR.19.01
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-2569b68224723978886f005fdbff083709a7110fe4c96be315d25152da16b20de14

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EN

ISO 13485 QMS

M.FR.20.01 - Impartiality Declaration

Code
M.FR.20.01
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
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SHA-256ef8a54d914820e3ebb5e694c94f258404ef037b50754955877acc17d15b0d071

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EN

ISO 13485 QMS

M.FR.23.02 - Certification Rules and General Conditions

Code
M.FR.23.02
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-25665da14c1699997e014f75f8e8c30f5625466abddc5716eb2be6c12e781ebce4b

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EN

ISO 13485 QMS

M.FR.23.03 - Product Information Receipt Form

Code
M.FR.23.03
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-2569757d6de19f10d204919d8a8f17f31bbb098c967333e8c85bfea161ac098a378

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EN

ISO 13485 QMS

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

Code
M.FR.24.01
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-25690f037be5c54db3274568ed0edb8065567c4712aa52f467a58c4263090778a66

Source-file checksum verified.

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EN

ISO 13485 QMS

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

Code
M.PR.07
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-2567b854963b0c3b518a8128e5bbfccb39a9b3890bc7a7f8978c80baffab06652b9

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EN

ISO 13485 QMS

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

Code
M.PR.10
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-2567fe70ce9e890881b162c70734530069e84abda21f29ac8b960d3ef76e8892822

Source-file checksum verified.

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EN

ISO 13485 QMS

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

Code
M.PR.11
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-2561ace2eab0599147917cb68b8ffcca20c6d4f2d2bb560c43d2713e92645fb443e

Source-file checksum verified.

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EN

ISO 13485 QMS

M.PR.21 - Certificate and Brand Usage Procedure

Code
M.PR.21
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-2561352e4020424a1bcba6adea55e81e20793aaabbfde4072e48309f920b79adff5

Source-file checksum verified.

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EN

ISO 13485 QMS

M.PR.24 - Appeals and Complaints Evaluation Procedure

Code
M.PR.24
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-25676a55505438b36f3d2ec62292522ecf6134a8de8fa12838b045c905c170500fb

Source-file checksum verified.

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EN

ISO 13485 QMS

M.PR.27 - Control of Subcontractors Activities Procedure

Code
M.PR.27
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-256ee43437ea84dddc92c56fce0777002611ce831aa4086e613e643778379fa2ed5

Source-file checksum verified.

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EN

ISO 13485 QMS

M.PR.31 - Remote Audit Procedure

Code
M.PR.31
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-256367ea3a6caa8efa4faa04bb4ff339953eeadf3aed483567bac632def5a537e1d

Source-file checksum verified.

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EN

ISO 13485 QMS

M.PR.32 - Safety Procedure for Pandemic

Code
M.PR.32
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-2567f8cb8bd89339a15e28e31337d697f4c52e3a392a7cbf3ba227379f4dc9c8ad6

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EN

ISO 13485 QMS

M.PR.38 - ISO 13485 Audit Duration Determination and Planning Procedure

Code
M.PR.38
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-256ac1ae90ed56da28a56dfe3e8532afd9335adc5be781f7995be0480b951f14c8a

Source-file checksum verified.

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EN

ISO 13485 QMS

M.PR.39 - ISO 13485 Audit Fee Determination Procedure

Code
M.PR.39
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-256ffc84aa5690fc1774003bbdd0a11006c7f50e886f27c9956f36d146e9e8db0ce

Source-file checksum verified.

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EN

ISO 13485 QMS

M.TL.07.01 - Pre-Application Instructions

Code
M.TL.07.01
Revision
Not stated in source
Language
EN
Effective date
Not stated in source
Replacement information
Not recorded in source
File integrity and source

SHA-2568d1b4ed67121405426b01571286da7994c062f7cfe1f2d84f3a56598236b4f6d

Source-file checksum verified.

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Practical guidance

Frequently asked questions

Why do some records say “revision not stated in source”?

The source website did not publish a verifiable revision value. NOTICE QMS must confirm the authoritative revision before production publication. No revision is inferred or invented.

What does the SHA-256 value show?

It identifies the exact migrated file. The migration process recalculated each checksum and matched it to the Stage 1 preservation inventory.