Resources and Documents

Legacy / transitional EN

MDD legacy/transitional

About the extension of MDD Certificates.

Code: Not assigned in source
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Legacy / transitional EN

MDD legacy/transitional

FR.19.01 Confidentiality Declaration

Code: FR.19.01
Revision: Not stated in source
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Legacy / transitional EN

MDD legacy/transitional

FR.20.01 Impartiality Declaration

Code: FR.20.01
Revision: Not stated in source
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Legacy / transitional EN

MDD legacy/transitional

FR.23.02 Certification Rules & General Conditions

Code: FR.23.02
Revision: Not stated in source
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Legacy / transitional EN

MDD legacy/transitional

FR.24.01 Customer Complaint Objection and Advice Form

Code: FR.24.01
Revision: Not stated in source
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Legacy / transitional EN

MDD legacy/transitional

ISO 17021 Accreditaion Certificate

Code: Not assigned in source
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Legacy / transitional EN

MDD legacy/transitional

M.FR.08.15 - Planned Change Notification Form

Code: M.FR.08.15
Revision: Not stated in source
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Legacy / transitional EN

MDD legacy/transitional

PR.09 Surveillance & Other Audits Procedure

Code: PR.09
Revision: Not stated in source
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SHA-256272eace894a2140cbc49579db47ba388115c47ff4b5cb7ffc328f98bd1f72836

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Legacy / transitional EN

MDD legacy/transitional

PR.23 Audit Fee Determination Procedure

Code: PR.23
Revision: Not stated in source
Effective date: Not stated in source
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Legacy / transitional EN

MDD legacy/transitional

PR.10 Certificates Suspention, Withdrawal & Notification Procedure

Code: PR.10
Revision: Not stated in source
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SHA-256b2b4e2cdea76e86cd856bc457814abf25517ad08083352d6d4720f53585432d1

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Legacy / transitional EN

MDD legacy/transitional

PR.11 Change of CB & NB Procedure

Code: PR.11
Revision: Not stated in source
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SHA-2563a41f635df30da7af2bac81e9218da96d2c39bee4cad6853d026986b8b96e33d

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Legacy / transitional EN

MDD legacy/transitional

PR.21 Certificate & Brand Usage Procedure

Code: PR.21
Revision: Not stated in source
Effective date: Not stated in source
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SHA-2561f2561f886a499f726beb56d3e3af926c4b5e4a2d7d06f7ff560a3de23452ba8

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Legacy / transitional EN

MDD legacy/transitional

PR.22 Audit Duration Determination & Planning Procedure

Code: PR.22
Revision: Not stated in source
Effective date: Not stated in source
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SHA-2561d38d6391749051b836acedc0eba601befcbb90d10a2ad714230b8674453b9a5

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Legacy / transitional EN

MDD legacy/transitional

PR.24 Appelas & Complaints Evaluation Procedure

Code: PR.24
Revision: Not stated in source
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Legacy / transitional EN

MDD legacy/transitional

PR.25 Certification Committee Work Procedure

Code: PR.25
Revision: Not stated in source
Effective date: Not stated in source
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Legacy / transitional EN

MDD legacy/transitional

PR.27 Control of Subcontracted Audit Activities Procedure

Code: PR.27
Revision: Not stated in source
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SHA-2562982d6a446d752d2221ebc8d244647a29a423080436467d325b59cca1bc5a622

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Legacy / transitional EN

MDD legacy/transitional

PR.31 Remote Audit Procedure

Code: PR.31
Revision: Not stated in source
Effective date: Not stated in source
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Legacy / transitional EN

MDD legacy/transitional

PR.32 Safety Procedure For Pandemic

Code: PR.32
Revision: Not stated in source
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SHA-2562001e99e429e64171360a40ae16fa8c2539b42459fd7cf087fc4c083afabbace

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Legacy / transitional 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
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MDR

ISO 17021 Accreditaion Certificate

Code: Not assigned in source
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SHA-25618e0029681d1615bde77293a69fa0c491476f5599888b9c064449512ea10bfc8

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MDR

M.FR.07.01 - Application Form

Code: M.FR.07.01
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MDR

M.FR.07.04 - MDR Certification Flowchart

Code: M.FR.07.04
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MDR

M.FR.07.07 - Structured Dialogue

Code: M.FR.07.07
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MDR

M.FR.08.15 - Planned Change Notification Form

Code: M.FR.08.15
Revision: Not stated in source
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MDR

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

Code: M.FR.09.01
Revision: Not stated in source
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MDR

M.FR.19.01 - Confidentiality Declaration

Code: M.FR.19.01
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SHA-2565b91947d2fcb9310f797f92728eccbb966da6276576623c1cc8460ad5ffd9c30

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MDR

M.FR.20.01 - Impartiality Declaration

Code: M.FR.20.01
Revision: Not stated in source
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SHA-256ef8a54d914820e3ebb5e694c94f258404ef037b50754955877acc17d15b0d071

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MDR

M.FR.23.02 - Certification Rules and General Conditions

Code: M.FR.23.02
Revision: Not stated in source
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MDR

M.FR.23.03 - Product Information Receipt Form

Code: M.FR.23.03
Revision: Not stated in source
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MDR

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

Code: M.FR.24.01
Revision: Not stated in source
Effective date: Not stated in source
Replaced revision: Not recorded in source

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SHA-256667d833ea0f934e70b94e31446ef038a8be357ad1a49e73130af8956b9af21f1

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MDR

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

Code: M.FR.36.01
Revision: Not stated in source
Effective date: Not stated in source
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SHA-256389d17a4e896c23d2e25eb75f6590f9505b16f58ddab2fea30ac673c68d22500

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MDR

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

Code: M.FR.36.03.B
Revision: Not stated in source
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SHA-256ad7695161f3d1da8d58d677fa2dd078ede515739fb4a34b6e6ed84d923bcd054

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MDR

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

Code: M.PR.07
Revision: Not stated in source
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MDR

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

Code: M.PR.10
Revision: Not stated in source
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MDR

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

Code: M.PR.11
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SHA-2568343ee691b4f24cbb641a5d1d7af40aa271adf12df14ec4bab5655534f60f52a

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MDR

M.PR.21 - Certificate and Brand Usage Procedure

Code: M.PR.21
Revision: Not stated in source
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SHA-2564041f25d352d453c9ff935b75c2de8bccdfbb0e03e66e9dad1f6f972fe291dc3

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MDR

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

Code: M.PR.22
Revision: Not stated in source
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MDR

M.PR.23 - Audit Fee Determination Procedure

Code: M.PR.23
Revision: Not stated in source
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MDR

M.PR.24 - Appeals and Complaints Evaluation Procedure

Code: M.PR.24
Revision: Not stated in source
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Withheld pending correction EN

MDR

M.PR.27 - Control of Subcontractors Activities Procedure

Code: M.PR.27
Revision: Not stated in source
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MDR

M.PR.30 - Advertisement and Promotional Activities Procedure

Code: M.PR.30
Revision: Not stated in source
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SHA-25692afd34a30d0a4971dcd51bead855d5417cd3d2225b5e25943c8f70ba13fa639

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MDR

M.PR.31 - Remote Audit Procedure

Code: M.PR.31
Revision: Not stated in source
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MDR

M.PR.32 - Safety Procedure for Pandemic

Code: M.PR.32
Revision: Not stated in source
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MDR

M.PR.35 - MDR Certification Procedure

Code: M.PR.35
Revision: Not stated in source
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SHA-2569494daa84745b5ddb5678b299740bc0c758685e6b10d18f31975fa4152f4ab59

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MDR

M.PR.36 - Distributors and Importers Certification Procedure

Code: M.PR.36
Revision: Not stated in source
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SHA-25699ced74969fcbc83d9feb6de0ca2075e3b37a348157a4756f08ff137530ef5d3

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MDR

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

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

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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
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SHA-2560d840f88c25083e0ff7c7eafc76fab8277d812e865f1601364b97566dff40588

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MDR

M.1B.23.01 - Certification Fees

Code: M.TB.23.01
Revision: Not stated in source
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SHA-2566708cb2970428082b87ab869c2c781b832a9929694f1a89fc5f9626d720e4d06

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MDR

M.1B.35.01 - Certification Programme Table

Code: M.TB.35.01
Revision: Not stated in source
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SHA-25613cd090c62120c7c5b4af80ee27a4018887d4be0985c1d965133961930379830

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MDR

M.TL.07.01 - Pre-Application Instructions

Code: M.TL.07.01
Revision: Not stated in source
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SHA-25632a1533ca8a94e2b3c8be4296124d460594f189b7bb2c0598e1c613f3b2b2e90

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MDR

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

Code: M.TL.07.04
Revision: Not stated in source
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ISO 13485 QMS

ISO 17021 Accreditaion Certificate

Code: Not assigned in source
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ISO 13485 QMS

M.FR.07.01 - Application Form

Code: M.FR.07.01
Revision: Not stated in source
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ISO 13485 QMS

M.FR.07.03 – ISO 13485 Certification Flowchart

Code: M.FR.07.03
Revision: Not stated in source
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ISO 13485 QMS

M.FR.08.15 - Planned Change Notification Form

Code: M.FR.08.15
Revision: Not stated in source
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ISO 13485 QMS

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

Code: M.FR.09.01
Revision: Not stated in source
Effective date: Not stated in source
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SHA-25634fc03285fc62b71fdac7aa6c5466e99ba74eebc40dce61f8623cbadc5fecdad

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ISO 13485 QMS

M.FR.19.01 - Confidentiality Declaration

Code: M.FR.19.01
Revision: Not stated in source
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ISO 13485 QMS

M.FR.20.01 - Impartiality Declaration

Code: M.FR.20.01
Revision: Not stated in source
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SHA-256ef8a54d914820e3ebb5e694c94f258404ef037b50754955877acc17d15b0d071

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ISO 13485 QMS

M.FR.23.02 - Certification Rules and General Conditions

Code: M.FR.23.02
Revision: Not stated in source
Effective date: Not stated in source
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SHA-25665da14c1699997e014f75f8e8c30f5625466abddc5716eb2be6c12e781ebce4b

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ISO 13485 QMS

M.FR.23.03 - Product Information Receipt Form

Code: M.FR.23.03
Revision: Not stated in source
Effective date: Not stated in source
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SHA-2569757d6de19f10d204919d8a8f17f31bbb098c967333e8c85bfea161ac098a378

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ISO 13485 QMS

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

Code: M.FR.24.01
Revision: Not stated in source
Effective date: Not stated in source
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SHA-25690f037be5c54db3274568ed0edb8065567c4712aa52f467a58c4263090778a66

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ISO 13485 QMS

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

Code: M.PR.07
Revision: Not stated in source
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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
Effective date: Not stated in source
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M.PR.11 - Change of Certification Body-Notified Body Procedure

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M.PR.21 - Certificate and Brand Usage Procedure

Code: M.PR.21
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M.PR.24 - Appeals and Complaints Evaluation Procedure

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M.PR.27 - Control of Subcontractors Activities Procedure

Code: M.PR.27
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M.PR.31 - Remote Audit Procedure

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M.PR.32 - Safety Procedure for Pandemic

Code: M.PR.32
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M.PR.38 - ISO 13485 Audit Duration Determination and Planning Procedure

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

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M.TL.07.01 - Pre-Application Instructions

Code: M.TL.07.01
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General certification

form.docx

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Resources and documents

Application resources

Certification information

Regulatory updates

Public document library

About the extension of MDD Certificates.

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

M.FR.08.15 - Planned Change Notification Form

PR.09 Surveillance & Other Audits Procedure

PR.23 Audit Fee Determination 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.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

ISO 17021 Accreditaion Certificate

M.FR.07.01 - Application Form

M.FR.07.04 - MDR Certification Flowchart

M.FR.07.07 - Structured Dialogue

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.FR.36.01 - Application Form – Importers & Distribitors

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

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.30 - Advertisement and Promotional Activities Procedure

M.PR.31 - Remote Audit Procedure

M.PR.32 - Safety Procedure for Pandemic

M.PR.35 - MDR Certification Procedure

M.PR.36 - Distributors and Importers 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

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

ISO 17021 Accreditaion Certificate

M.FR.07.01 - Application Form

M.FR.07.03 – ISO 13485 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.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.38 - ISO 13485 Audit Duration Determination and Planning Procedure

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

M.TL.07.01 - Pre-Application Instructions

form.docx

Frequently asked questions