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MDCG 2021-15 rev.1
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MDCG 2021-15 Rev. 1
Application form for designation
as a notified body
or extension of the scope of designation under Regulation (EU) 2017/745
on medical devices (MDR)
Revision 1 – January 2025
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.
The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law.
applicable for MDR IVDR
| MDCG 2021-15 revision 1 changes |
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| Update the document to align the structure with MDR Annex VII and related Preliminary assessment review (PAR) form template |
Application form to be submitted by a conformity assessment body when applying for designation as a notified body or by a notified body when extending their scope of designation under the medical devices Regulation (MDR)
This form describes the information to be submitted by notified bodies when applying for designation under the MDR or when extending their scope of designation. The first column refers to the relevant sections of Annex VII to Regulation (EU) 2017/745. The third column refers to legal provisions (in MDR or other Union legislation) and MDCG guidance also applicable to the specific requirement in MDR Annex VII.
All of the supporting documents that will be provided for each of the numbered sections should be listed in a separate line below (and optionally in the Annex: List of Documents attached to this Application Form) indicating the identification number, the title and the date or revision of the document. When only a section or page of a document is relevant for the specific requirement, reference should be done to such section and/or page. If a requirement listed in a numbered section is considered as not applicable, applicant conformity assessment bodies should write “NA” in the line below. All of the documentation/files contained in the application should be provided following the format requirements defined by the Designating Authority taking into consideration section 2.1.3 of MDCG 2022-13.
The fourth column, on the right side, should be used only by designating authorities for recording their completeness check (as per Art. 39 to the MDR). If the tick box shows “X” or (manually) “” the designating authority confirms that the supporting documentation have been provided for the specific requirement. In case any tick box stays empty, but the application is considered complete, a brief justification should be included in the box provided in the last page.
| BASIC INFORMATION |
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| Name of the national authority responsible for notified bodies (DA) |
| Name of the applicant conformity assessment body (CAB) |
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| If applicable, notified body's identification number |
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| Address of the CAB |
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| Contact person |
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| Telephone |
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| Company registration number and company register |
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| Date of application |
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| G. GENERAL DOCUMENTATION |
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| G.1 | Scope of designation requested under the MDR (MDCG 2021- 17 to be appended) |
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| G.2 | Authorisation to represent the conformity assessment body by the person who has submitted the application on behalf of the body, unless such authorisation follows from the documentation specified in point 1.1.1 |
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| G.3 | Valid accreditation certificate and the corresponding evaluation report as referred to in Article 38 (2) of Regulation (EU) 2017/745 |
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| 1. ORGANISATIONAL AND GENERAL REQUIREMENTS |
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| 1.1 Legal status and organisational structure | |||
|---|---|---|---|
| 1.1.1 Annex VII | Documentation detailing the conformity assessment body’s legal personality and its status, including information about ownership and the legal or natural persons exercising control over the conformity assessment body | MDCG 2019-6 Q I.2 | |
| 1.1.2 Annex VII | Documentation detailing the activities of the organisation to which the conformity assessment body belongs, the organisational structure and governance of that organisation, and its relationship with the conformity assessment body | MDCG 2019-6 Q I.3 Q I.4 |
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| 1.1.3 Annex VII | Documentation detailing the activities and responsibilities of any legal entity which is wholly or partly owned by the conformity assessment body or which wholly or partly owns the conformity assessment body, and the legal and operational relationships with the conformity assessment body |
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| 1.1.4 - 1.1.5 Annex VII | Documentation describing the organisational structure, the allocation of responsibilities, reporting lines and the operational management of the conformity assessment body | MDCG 2019-6 Q I.4 |
| 1.1.6 Annex VII | Documentation detailing the functions, responsibilities and authorities of the top-level management, indicating the overall authority and responsible person for each of the following: | ||
|---|---|---|---|
| Provision of adequate resources for conformity assessment activities | |||
| Development of procedures and policies for the operation of the notified body | |||
| Supervision of implementation of the procedures, policies and quality management systems of the notified body | |||
| Supervision of the notified body's finances | |||
| Activities and decisions taken by the notified body, including contractual agreements | |||
| Delegation of authority to personnel and/or committees, where necessary, for the performance of defined activities | |||
| Interaction with the authority responsible for notified bodies and the obligations regarding communications with other competent authorities, the Commission and other notified bodies | |||
| Individual having overall responsibility for all conformity assessment activities in relation to devices (head of the notified body) | Annex VII 3.1.1 Last paragraph | ||
| 1.2 Independence and impartiality | |||
|---|---|---|---|
| 1.2.1 -1.2.2 Annex VII | Documentation detailing the structures, policies and procedures the conformity assessment body has in place to safeguard and promote the principles of independence, impartiality and objectivity throughout its whole organisation (e.g. corporate group), personnel and activities, including procedures providing for the identification, investigation and resolution of any case in which a conflict of interest may arise | Annex VII 1.1.2 | |
| MDCG 2019-6 Q I.3 Q I.4 Q I.5 Q I.9 | |||
| Personnel commitment and written statement | Annex VII 2.4 |
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| 1.2.3 -1.2.7 Annex VII | Independence of the notified body, the larger organisation to which it belongs, the top-level management and conformity assessment personnel Documentation on ensuring independence and impartiality with respect to: - Medical device industry (1.2.3) - Consultancy activities (1.2.3 - 1.2.4) - Remuneration (1.2.5) - Declarations of interest by top-level management (1.2.5) - Public ownership (1.2.6) - Subsidiaries, subcontractors and external experts (1.2.7; 3.4.2) | Article 53.5 Annex VII 1.1.2 1.2.9 2.4 |
|---|---|---|
| MDCG 2019-6 Q I.3 Q I.4 Q I.5 Q I.6 Q I.8 Q I.9 |
| 1.2.8 Annex VII | Documentation demonstrating how the conformity assessment body operates with a set of consistent, fair and reasonable terms and conditions, taking into account small and medium size businesses |
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| 1.3 Confidentiality | ||
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| 1.3.1 - 1.3.2 Annex VII | Documentation detailing how the conformity assessment body ensures that its personnel, committees, subsidiaries, subcontractors, and any associated body or personnel of external bodies respect the confidentiality of the information (including proprietary rights) which comes into their possession | |
| Annex VII 2.4; 3.4.2 |
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| 1.4 Liability | ||||
| 1.4.1 - 1.4.2 Annex VII | Documentation on the liability insurance covering conformity assessment activities, including its scope and overall financial value | MDCG 2019-6 Q I.10 | ||
| 1.5 Financial requirements | ||
|---|---|---|
| 1.5 Annex VII | Documentation detailing the conformity assessment body’s financial resources, including its financial capacity and long-term economic viability | |
| 1.6 Participation in coordination activities | |||
| 1.6.1 - 1.6.2 Annex VII | Documentation on the CAB’s procedures ensuring its personnel is involved in standardisation activities and in the work of the notified body coordination group and how personnel are informed. Strategy to take into consideration guidance and best practice documents | Article 49 | |
| MDCG 2019-6 Q I.1 | |||
| 2. QUALITY MANAGEMENT REQUIREMENTS | |||
|---|---|---|---|
| 2.1 - 2.2 first indent Annex VII | Management system structure and the list of all quality management system documents, including policies and objectives | Annex VII 4.1 | |
| 2.2 second indent Annex VII | Policies for assignment of activities and responsibilities to personnel |
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| 2.2 third indent Annex VII | Documentation detailing the assessment and decision-making processes in accordance with the tasks, responsibilities and role of the notified body's personnel and top-level management | |
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| 2.2 fourth indent Annex VII | Documentation detailing the planning, conduct, evaluation and, if necessary, adaptation of the conformity assessment procedures | |
| 2.2 fifth indent Annex VII | Procedures for control of documents including verification that the documents have the same content where documents are used in different languages | Annex VII 2.2 Last paragraph |
| 2.2 sixth indent Annex VII | Procedures for control of records |
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| 2.2 seventh indent Annex VII | Procedures for management review |
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| 2.2 eighth indent Annex VII | Procedures for internal audits |
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| 2.2 ninth indent Annex VII | Procedures for corrective and preventive actions |
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| 2.2 tenth indent Annex VII | Procedures for complaints and appeals |
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| 2.2 eleventh indent Annex VII | Procedures for continuous training | Annex VII 3.1.2 3.5.2 |
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| 2.3 Annex VII | Documentation relating to the implementation and maintenance of the quality management system throughout the conformity assessment body’s organisation, including subsidiaries and subcontractors involved in conformity assessment activities | |
| 2.4 Annex VII | Model declaration of commitment of the CAB’s personnel to comply with the procedures |
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| Articles 36.2 44.2 44.3 | Procedures on the NB’s obligation to make available and submit upon requests all relevant documentation |
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| Articles 44.1 46.3 46.5 46.9 | Procedures on the NB’s obligation for information in case of relevant changes and ceasing of activities |
| 3. RESOURCE REQUIREMENTS | ||||
|---|---|---|---|---|
| 3.1 General | ||||
| 3.1.1 Annex VII | Documentation detailing the CAB’s: - Equipment, facilities and competence (including testing facilities) needed to perform properly the technical, scientific and administrative tasks - Permanent availability of personnel and in sufficient numbers, including templates of employment and other contracts used for the personnel - Sufficient internal competence to critically evaluate assessments conducted by external expertise (3.4.3) | Article 36.1 | ||
| MDCG 2019-6 Q III.2 Q III.3 | ||||
| 3.1.2 Annex VII | Documentation detailing the implementation of a system for exchange of experience and a continuous training and education programme | |||
| 3.1.3 Annex VII | Documentation detailing: - The extent and limits of duties and responsibilities of the personnel, including subcontractors and external experts - The level of authorisation of the personnel - The process for informing the personnel accordingly | |||
| 3.2 Qualification criteria in relation to personnel | ||||
| 3.2.1 - 3.2.2 Annex VII | Documentation detailing: - Process to establish and document the qualification criteria (providing a sufficient level of detail for the required qualification within the subdivisions of the applied-for scope) - Process for selection and authorisation of personnel, including the required initial and ongoing training | NBOG BPG 2017-2 | ||
| 3.2.2 - 3.2.7 Annex VII | - Specific qualification criteria (3.2.2) Qualification criteria per role: - Personnel responsible for establishing qualification criteria and for authorising other personnel (3.2.3) - Personnel with relevant clinical expertise (Internal clinician/Clinical specialist) (3.2.4) - Product reviewers (3.2.5) - Site auditors (3.2.6) - Final reviewers and decision-makers (3.2.7) | Article 36.1 (employed by) | ||
| NBOG BPG 2017-2 | ||||
| MDCG 2019-6 Q III.4 Q III.6 Q III.7 Q IV.6 | ||||
| 3.3 Documentation of qualification, training and authorisation of personnel | ||||
| 3.3.1 Annex VII | Procedure in place to fully document the qualification of each member of personnel and the satisfaction of the qualification criteria | NBOG BPG 2017-2 | ||
| MDCG 2019-6 Q III.1 | ||||
| 3.3.2 first indent Annex VII | Matrix detailing the authorisations (including any limitations) and responsibilities of the personnel, including employment status (e.g. full-time, external, etc.) and location of all internal and external personnel; the authorisations shall be specified by using the codes set out in the Commission Implementing Regulation on codes and corresponding types of devices | MDCG 2019-14 | ||
| 3.3.2 second indent Annex VII | Model/template of the record attesting authorisation of qualified personnel; the records shall contain a rationale for defining the scope of the responsibilities for each of the assessment personnel and records of the conformity assessment activities carried out by each of them Representative sample of records (at least one per role/function) demonstrating compliance with the qualification criteria for the authorisation of the personnel member (mock file or blacked out document might be acceptable) | |||
| 3.4 Subcontractors and external experts | ||||
| 3.4.1 Annex VII | Lists of all subcontractors and subsidiaries, including a description of their functions in relation to conformity assessment activities (e.g. external laboratories) or administrative tasks (e.g. information technologies) and contractual arrangements in place | Article 37 Article 57(a) | ||
| 3.4.2 Annex VII | Documentation detailing the conditions under which subcontracting may take place | |||
| 3.5 Monitoring of competences, training, exchange of experience | ||||
| 3.5.1 - 3.5.2 Annex VII | Documentation detailing: -The initial evaluation, on-going monitoring and periodic review of competence of the internal and external personnel, including the identification of training needs and drawing up of training plans - How the personnel is aware of Union and national law in force on devices, relevant harmonised standards, CS, guidance documents and the results of the coordination activities of NBCG-Med - Verification that personnel takes part in the internal exchange of experience and the continuous training and education programme | Article 49 | ||
| MDCG 2019-6 Q III.5 | ||||
| 4. PROCESS REQUIREMENTS | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 4.1 General | |||||||||
| 4.1 1st paragraph Annex VII | Overview of processes for the conduct of each conformity assessment activity comprising the individual steps from pre-application activities up to decision-making and surveillance, e.g. flowcharts | Annex VII 2.1 | |||||||
| 4.1 2nd paragraph Annex VII | Documentation detailing the internal activities of the CAB which shall not be subcontracted | MDCG 2019-6 Q III.6 | |||||||
| 4.2 Notified body quotations and pre-application activities | |||||||||
| 4.2 (a) Annex VII | Description of the application procedure by which manufacturers can obtain certification, including which languages are acceptable | MDCG 2019-6 Q I.6 | |||||||
| 4.2 (b) Annex VII | Procedures relating to fees charged and financial conditions | Article 50 | |||||||
| MDCG 2019-6 Q V.2 | |||||||||
| MDCG 2023-2 | |||||||||
| 4.2 (c) Annex VII | Procedures in relation to advertising of conformity assessment services | ||||||||
| 4.2 (d) Annex VII | Procedures relating to the review of pre-application information | Manual on borderline and classification | |||||||
| MDCG 2021-24 | |||||||||
| MDCG 2022-5 | |||||||||
| 4.2 (e) Annex VII | Procedures to ensure that all contracts relating to the conformity assessment activities are concluded directly between the manufacturer and the conformity assessment body | ||||||||
| 4.3 Application review and contract | |||||||||
| 4.3 1st paragraph Annex VII | Template application form | MDCG 2019-6 Q I.7 | |||||||
| 4.3 2nd paragraph Annex VII | Template contract including terms and conditions and obligations of the CAB in relation to conformity assessment activities (terms and conditions might be in a separate annex to the contract template) | ||||||||
| 4.3 (a) – (e) Annex VII | Procedures relating to review of applications, including documented outcome of each review and notification to EUDAMED of refusals or withdrawals of applications | Article 53.2 Application sections in Annex IX-XI | |||||||
| MDCG 2021-1 | |||||||||
| 4.4 Allocation of resources | |||||||||
| 4.4 1st and 2nd paragraph Annex VII | Procedures and forms to ensure that conformity assessment activities are conducted by appropriately qualified and authorised personnel, and that allocation of tasks and changes thereto are documented | Annex VII 4.5.1 second indent | ☐ | ||||||
| MDCG 2019-6 Q IV.6 Q IV.7 | |||||||||
| MDCG 2019-14 | |||||||||
| 4.4 2nd paragraph Annex VII | Procedures and forms to identify one individual responsible for each application | MDCG 2019-6 Q IV.7 | |||||||
| 4.5 Conformity assessment activities | |||||||||
| 4.5.1 first indent Annex VII | Procedures for planning the conduct of each individual project | ||||||||
| 4.5.1 second indent Annex VII | Procedures for the rotation of the members of the assessment team at appropriate intervals | Annex IX 3.6 | |||||||
| 4.5.1 third indent Annex VII | Procedures specifying the rationale for fixing time limits for completion of the conformity assessment | ||||||||
| 4.5.1 Fourth to sixth indents Annex VII | Procedures for the assessment of the manufacturer's technical documentation including review of manufacturer's procedures and documentation relating to the evaluation of pre-clinical aspects and relating to clinical evaluation | Annex VII 4.5.3 4.5.4 4.5.5 | |||||||
| 4.5.1 seventh indent Annex VII | Procedures for the assessment of the interface between the manufacturer’s risk management process and its appraisal and analysis of the pre-clinical and clinical evaluation | ||||||||
| 4.5.1 eighth indent Annex VII | Procedures to carry out the specific procedures referred to in Sections 5.2 to 5.4 of Annex IX | ||||||||
| 4.5.1 ninth indent Annex VII | In the case of class IIa or class IIb devices, procedures to assess the technical documentation of devices selected on a representative basis | Article 52 Annex VII 4.5.2 Annex IX 2.3 3.5 | |||||||
| MDCG 2019-13 | |||||||||
| 4.5.1 tenth and eleventh indents Annex VII | Procedures to plan and periodically carry out appropriate surveillance audits and assessments, carry out or request certain tests to verify the proper functioning of the quality management system, to perform unannounced on site audits, and to verify that the manufactured device is in conformity with the technical documentation | Annex VII 4.10 | |||||||
| 4.5.1 twelfth indent Annex VII | Procedures to evaluate and verify a manufacturer's compliance with relevant Annexes | ||||||||
| 4.5.1 Last paragraph Annex VII | Procedures to take into consideration available CS, guidance and best practice documents and harmonised standards | MDCG 2019-6 Q IV.11 | |||||||
| 4.5.2 Quality management system auditing | |||||||||
| 4.5.2 Annex VII | Procedures for the assessment of quality management systems, according to each specific conformity assessment activity covered by the application and the class of the device, including: - Drawing-up audit programmes - Auditing the various manufacturing sites, suppliers and/or subcontractors - Drawing-up audit plans - Drawing-up sampling plans for classes IIa and IIb - Selection of site auditors | Annex IX Chapter I | |||||||
| MDCG 2019-6 Q IV.2 | |||||||||
| MDCG 2019-13 | |||||||||
| MDCG 2022-17 | |||||||||
| 4.5.3. Product verification | |||||||||
| 4.5.3 Assessment of the technical documentation Annex VII | Procedures to assess the manufacturer’s technical documentation, including: - Allocations of personnel - Conformity of the design - Examination of the implementation by manufacturers of incoming, in-process and final checks - Physical or laboratory tests, if required | Article 52 Annex II Annex III Annex IX Chapter II | |||||||
| 4.5.3 Type-examinations Annex VII | Procedures to examine and assess the manufacturer’s technical documentation and verify the type, including establishment of test plans | Annex X | |||||||
| 4.5.3 Verification by examination and testing of every product Annex VII | Documentation relating to verification by examination and testing of every product, including establishment of test plans | Annex XI (B) | |||||||
| 4.5.4 Pre-clinical evaluation assessment | |||||||||
| 4.5.4 Annex VII | Procedures for the review of the manufacturer’s procedures and documentation relating to the evaluation of pre-clinical aspects | Annex II 6.1 | |||||||
| 4.5.5 Clinical evaluation assessment | |||||||||
| 4.5.5 Annex VII | Procedures for the review of the manufacturer’s procedures and documentation relating to clinical evaluation, including the validation of the summary of safety and clinical performance (for implantable and class III) and the upload of the summary to EUDAMED | Article 32 Article 61 Annex II 6.1 Annex XIV | |||||||
| MDCG 2019-9 | |||||||||
| MDCG 2020-5 | |||||||||
| MDCG 2020-6 | |||||||||
| MDCG 2021-1 | |||||||||
| 4.5.6 Specific Procedures | |||||||||
| 4.5.6 Annex VII | Documentation relating to documented procedures, expertise and facilities to carry out the specific procedures: - Consultation to expert panel (5.1 Annex IX) - Consultation to medicinal products authority (5.2 and 5.4 Annex IX) - Consultation to human tissues and cells competent authority (5.3.1 Annex IX) - Preparation of a summary evaluation report for devices manufactured utilising TSE susceptible tissues or cells of animal origin (5.3.2 Annex IX) - Batch verification for derivatives from human blood or human plasma (6 Annex IX and 16 Annex XI) | Articles 54 and 55 Annex IX Sections 5 and 6 Annex X Section 6 Annex XI Section 16 | |||||||
| Regulation 722/2012 | |||||||||
| MDCG 2019-3 | |||||||||
| 4.6 Reporting | |||||||||
| 4.6 Annex VII | Documentation detailing how all steps of the conformity assessment are documented and relevant templates of reports/records, in particular: - Records related to QMS audits - Technical Documentation Assessment Report (TDAR) - Clinical Evaluation Assessment report (CEAR) - Detailed report for each specific project, including the recommendation for a final review and for a final decision - Procedure to provide the report to the manufacturer in question | MDCG 2020-13 | |||||||
| 4.7 Final review | |||||||||
| 4.7 Annex VII | Documentation relating to the final review process carried out prior to making a final decision | ||||||||
| 4.8 Decisions and Certifications | |||||||||
| 4.8 Annex VII | Documentation relating to the final decision process, including: - Procedures for decision-making for the issuance, suspension, restriction and withdrawal of certificates - Certificate templates intended to be used for the different types of conformity assessments for which the CAB seeks designation - Notification of the outcome of the assessment and the resultant decision to the manufacturer and EUDAMED | Articles 56 and 57(g) Annex XII | |||||||
| MDCG 2018-8 | |||||||||
| MDCG 2019-6 Q IV.3 Q IV.6 Q IV.8 | |||||||||
| MDCG 2021-1 | |||||||||
| 4.9 Changes and modifications | |||||||||
| 4.9 Annex VII | Documentation detailing manufacturers’ information obligations and the CAB’s assessment of changes, including documented procedures and contractual arrangements | MDCG 2019-6 Q IV.9 | |||||||
| 4.10 Surveillance activities and post-certification monitoring | |||||||||
| 4.10 Annex VII | Documentation detailing the following: | ||||||||
| Screening | Procedures for screening of relevant sources of scientific and clinical data and post-market information relating to the scope of designation | ||||||||
| Surveillance activities | Procedures in relation to surveillance activities, in particular to: - Define how and when surveillance activities of manufacturers are to be conducted (on at least an annual basis) - Conduct unannounced on-site audits - Assessment of the documentation on vigilance, PMS and PMCF - Sample and test devices and technical documentation - Impose specific restrictions on the relevant certificate, or suspend or withdraw it | Annex IX Sections 3.3 and 3.4 Annex XI Section 7 | |||||||
| MDCG 2019-6 Q IV.10 | |||||||||
| MDCG 2020-7 | |||||||||
| MDCG 2020-8 | |||||||||
| MDCG 2023-3 | |||||||||
| Vigilance | Procedures to review vigilance data which the NB has access under Article 92(2) and estimating the impact on issued certificates, including the recording of the results of the evaluation and any decisions taken | ||||||||
| PSUR | Documentation relating to the review of periodic safety update reports | Article 86 | |||||||
| MDCG 2022-21 | |||||||||
| Conditions | Procedures related to conditions for certification | ||||||||
| 4.11 Re-certification | |||||||||
| 4.11 Annex VII | Documentation detailing the conduct of re-certification reviews and the renewal of certificates | MDCG 2019-6 Q IV.12 | |||||||
| Article 58 | Documentation relating to voluntary changes of a notified body | MDCG 2018-8 | |||||||
| MDCG 2019-6 Q IV.4 | |||||||||
| 5. MOCK-UP FILES | ||
| 5.1 | Only to be provided at the beginning of the on-site assessment If applicable, please indicate how many mock up (including technical documentation and the assessment thereof) will be made available at the beginning of the onsite assessment, including the type of devices and the conformity assessment activities to be covered. | |
| In case any tick box above stays empty, please provide a brief justification for considering the application complete |
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