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MDCG 2024-9
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MDCG 2024-9
Preliminary re-assessment review template –
IVDR (Regulation (EU) 2017/746)
May 2024
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.
Preliminary re-assessment review template - IVDR (Regulation (EU) 2017/746)
| DETAILS ON THE NB’s DOCUMENTATION FOR RE-ASSESSMENT AND THE REVIEWERS | |
|---|---|
| Name and identification number of the Notified Body (NB) | |
| Name of Designating Authority (DA) | |
| DA’s reference number(s) | |
| In case an Extension to Scope of designation to be conducted in parallel with a re-assessment, codes and/or conformity assessment activities (if applicable) to be added | |
| Date the NB’s documentation was received by DA | |
| Languages in which the NB’s documentation for re-assessment was provided | |
| Date on which the NB’s documentation for re-assessment has been sent to the European Commission together with the completeness check form | |
| Name of the reviewer(s) | |
| Date(s) of the review | |
| In case the form is used by the DA for intermediate stages of the review, date(s) of previous review(s)/report(s) on this NB’s documentation for re-assessment | |
| DA’s MONITORING AND ASSESSMENT ACTIVITIES | |
|---|---|
| DA should provide the Joint Assessment Team with recent results of their monitoring and assessment activities, for example: - Annual assessment plan and reports from last annual surveillance assessments (Art 40.4) - Reports of observed audits (Art 40.5) - Sampling plan and outcome of the assessment of manufacturers’ technical documentation reviews (Art 41.1 and 41.2) | |
| DA’s general comments on the monitoring of the NB, if applicable | |
| OUTCOME OF THE REVIEW | |
|---|---|
| Once all the documentation has been examined, please indicate proposed on-site re-assessment dates: | |
| DA’s general comments on the review, if applicable | |
| REVIEW OF THE NB’s DOCUMENTATION FOR RE-ASSESSMENT |
|---|
| G. GENERAL DOCUMENTATION | |||||||
|---|---|---|---|---|---|---|---|
| List of comments on single documents | |||||||
| G.1 Relevant changes to the conformity assessment activities (including changes to the scope of designation and major changes to the NB’s quality management system) occurred since its initial designation/last re-assessment | |||||||
| MDCG 2021-18 | Comment | ||||||
| Title and Revision Document 2 | Comment | ||||||
| G.2 Authorisation to represent the NB by the person who has submitted the documentation for re-assessment on behalf of the NB, unless such authorisation follows from the documentation specified in point 1.1.1 | |||||||
| Title and Revision Document 1 | Comment | ||||||
| Title and Revision Document 2 | Comment | ||||||
| G.3 Valid accreditation certificate and the corresponding evaluation report as referred to in Article 34(2) of Regulation (EU) 2017/746 | |||||||
| Title and Revision Document 1 | Comment | ||||||
| Title and Revision Document 2 | Comment | ||||||
| 1. ORGANISATIONAL AND GENERAL REQUIREMENTS | |||||||
| List of comments on single documents6 | |||||||
| 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 | |||||
| Title and Revision Document 1 | Comment | ||||||
| Title and Revision Document 2 | Comment | ||||||
| 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 | |||||
| Title and Revision Document 1 | Comment | ||||||
| Title and Revision Document 2 | Comment | ||||||
| 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 | ||||||
| Title and Revision Document 1 | Comment | ||||||
| Title and Revision Document 2 | Comment | ||||||
| 1.1.4 -1.1.5 Annex VII | Documentation describing the organisational structure, the allocation of responsibilities, reporting lines and the operational management conformity assessment body | MDCG 2019-6 Q I.4 | |||||
| Title and Revision Document 1 | Comment | ||||||
| Title and Revision Document 2 | Comment | ||||||
| 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 | Responsible person (position or role, no individual name) Relevant documents and Comment | ||||||
| Development of procedures and policies for the operation of the notified body | Responsible person (position or role, no individual name) Relevant documents and Comment | ||||||
| Supervision of implementation of the procedures, policies and quality management systems of the notified body | Responsible person (position or role, no individual name) Relevant documents and Comment | ||||||
| Supervision of the notified body's finances | Responsible person (position or role, no individual name) Relevant documents and Comment | ||||||
| Activities and decisions taken by the notified body, including contractual agreements | Responsible person (position or role, no individual name) Relevant documents and Comment | ||||||
| Delegation of authority to personnel and/or committees, where necessary, for the performance of defined activities | Responsible person (position or role, no individual name) Relevant documents and Comment | ||||||
| Interaction with the authority responsible for notified bodies and the obligations regarding communications with other competent authorities, the Commission and other notified bodies | Responsible person (position or role, no individual name) Relevant documents and Comment | ||||||
| Individual having overall responsibility for all conformity assessment activities in relation to devices (head of the notified body) | Responsible person (position or role, no individual name) Relevant documents and Comment | 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 | Comment | Annex VII 2.4 | |||||
| Title and Revision Document 2 | Comment | ||||||
| 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: - IVD 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 49.5 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 | |||||||
| Title and Revision Document 1 | Comment | ||||||
| Title and Revision Document 2 | Comment | ||||||
| 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 | ||||||
| Title and Revision Document 1 | Comment | ||||||
| Title and Revision Document 2 | Comment | ||||||
| 1.3 Confidentiality | |||||||
| 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 and secrecy of the information (including proprietary rights) which comes into their possession | ||||||
| Personnel commitment and written statement | Comment | Annex VII 2.4; 3.4.2 | |||||
| Title and Revision Document 2 | Comment | ||||||
| 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 | |||||
| Title and Revision Document 1 | Comment | ||||||
| Title and Revision Document 2 | Comment | ||||||
| 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 | ||||||
| Title and Revision Document 1 | Comment | ||||||
| Title and Revision Document 2 | Comment | ||||||
| 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 45 | |||||
| MDCG 2019-6 Q I.1 | |||||||
| Title and Revision Document 1 | Comment | ||||||
| Title and Revision Document 2 | Comment | ||||||
| 2. QUALITY MANAGEMENT REQUIREMENTS | |||
|---|---|---|---|
| List of comments on single documents | |||
| 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 | |
| Title and Revision Document 1 | Comment | ||
| Title and Revision Document 2 | Comment | ||
| 2.2 second indent Annex VII | Policies for assignment of activities and responsibilities to personnel | ||
| Title and Revision Document 1 | Comment | ||
| Title and Revision Document 2 | Comment | ||
| 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 | ||
| Title and Revision Document 1 | Comment | ||
| Title and Revision Document 2 | Comment | ||
| 2.2 fourth indent Annex VII | Documentation detailing the planning, conduct, evaluation and, if necessary, adaptation of the conformity assessment procedures | ||
| Title and Revision Document 1 | Comment | ||
| Title and Revision Document 2 | Comment | ||
| 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 | |
| Title and Revision Document 1 | Comment | ||
| Title and Revision Document 2 | Comment | ||
| 2.2 sixth indent Annex VII | Procedures for control of records | ||
| Title and Revision Document 1 | Comment | ||
| Title and Revision Document 2 | Comment | ||
| 2.2 seventh indent Annex VII | Procedures for management review | ||
| Title and Revision Document 1 | Comment | ||
| Title and Revision Document 2 | Comment | ||
| 2.2 eighth indent Annex VII | Procedures for internal audits | ||
| Title and Revision Document 1 | Comment | ||
| Title and Revision Document 2 | Comment | ||
| 2.2 ninth indent Annex VII | Procedures for corrective and preventive actions | ||
| Title and Revision Document 1 | Comment | ||
| Title and Revision Document 2 | Comment | ||
| 2.2 tenth indent Annex VII | Procedures for complaints and appeals | ||
| Title and Revision Document 1 | Comment | ||
| Title and Revision Document 2 | Comment | ||
| 2.2 eleventh indent Annex VII | Procedures for continuous training | Annex VII 3.1.2 3.5.2 | |
| Title and Revision Document 1 | Comment | ||
| Title and Revision Document 2 | Comment | ||
| 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 | ||
| Title and Revision Document 1 | Comment | ||
| Title and Revision Document 2 | Comment | ||
| 2.4 Annex VII | Model declaration of commitment of the CAB’s personnel to comply with the procedures | ||
| Title and Revision Document 1 | Comment | ||
| Title and Revision Document 2 | Comment | ||
| Articles 32.2 40.2 40.3 | Procedures on the NB’s obligation to make available and submit upon requests all relevant documentation | ||
| Title and Revision Document 1 | Comment | ||
| Title and Revision Document 2 | Comment | ||
| Articles 40.1 42.3 42.5 42.9 | Procedures on the NB’s obligation for information of relevant changes and ceasing of activities | ||
| Title and Revision Document 1 | Comment | ||
| Title and Revision Document 2 | Comment | ||
| 3. RESOURCE REQUIREMENTS | |||||
|---|---|---|---|---|---|
| List of comments on single documents | |||||
| 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 32.1 | |||
| MDCG 2019-6 Q III.2 Q III.3 | |||||
| Title and Revision Document 1 | Comment | ||||
| Title and Revision Document 2 | Comment | ||||
| 3.1.2 Annex VII | Documentation detailing the implementation of a system for exchange of experience and a continuous training and education programme | ||||
| Title and Revision Document 1 | Comment | ||||
| Title and Revision Document 2 | Comment | ||||
| 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 information the personnel accordingly | ||||
| Title and Revision Document 1 | Comment | ||||
| Title and Revision Document 2 | Comment | ||||
| 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 | |||
| Title and Revision Document 1 | Comment | ||||
| Title and Revision Document 2 | Comment | ||||
| 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 32.1 (employed by) | |||
| NBOG BPG 2017-2 | |||||
| MDCG 2019-6 Q III.4 Q III.6 Q III.7 Q IV.6 | |||||
| Title and Revision Document 1 | Comment | ||||
| Title and Revision Document 2 | Comment | ||||
| 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 | |||||
| Title and Revision Document 1 | Comment | ||||
| Title and Revision Document 2 | Comment | ||||
| 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 2021-14 | |||
| Title and Revision Document 1 | Comment | ||||
| Title and Revision Document 2 | Comment | ||||
| 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) | ||||
| Title and Revision Document 1 | Comment | ||||
| Title and Revision Document 2 | Comment | ||||
| 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 33 Article 52(a) | |||
| Title and Revision Document 1 | Comment | ||||
| Title and Revision Document 2 | Comment | ||||
| 3.4.2 Annex VII | Documentation detailing the conditions under which subcontracting may take place | ||||
| Title and Revision Document 1 | Comment | ||||
| Title and Revision Document 2 | Comment | ||||
| 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 45 | |||
| MDCG 2019-6 Q III.5 | |||||
| Title and Revision Document 1 | Comment | ||||
| Title and Revision Document 2 | Comment | ||||
| 4. PROCESS REQUIREMENTS | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| List of comments on single documents | ||||||||||||
| 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 | ||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 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 | ||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 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 | ||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 4.2 (b) Annex VII | Procedures relating to fees charged and financial conditions | Article 46 | ||||||||||
| MDCG 2019-6 Q V.2 | ||||||||||||
| MDCG 2023-2 | ||||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 4.2 (c) Annex VII | Procedures in relation to advertising of conformity assessment services | |||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 4.2 (d) Annex VII | Procedures relating to the review of pre-application information | Manual on borderline and classification | ||||||||||
| MDCG 2020-16 | ||||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 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 | |||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 4.3 Application review and contract | ||||||||||||
| 4.3 1st paragraph Annex VII | Template application form | MDCG 2019-6 Q I.7 | ||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 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) | |||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 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 49.2 Application sections in Annex IX-XI | ||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 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 2021-14 | ||||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 4.4 2nd paragraph Annex VII | Procedures and forms to identify one individual responsible for each application | MDCG 2019-6 Q IV.7 | ||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 4.5 Conformity assessment activities | ||||||||||||
| 4.5.1 first indent Annex VII | Procedures for planning the conduct of each individual project | |||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 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 | ||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 4.5.1 third indent Annex VII | Procedures specifying the rationale for fixing time limits for completion of the conformity assessment | |||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 4.5.1 Fourth and fifth indents Annex VII | Procedures for the assessment of the manufacturer's technical documentation including review of manufacturer's procedures and documentation relating to performance evaluation | Annex VII 4.5.3 4.5.4 | ||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 4.5.1 sixth indent Annex VII | Procedures for the assessment of the interface between the manufacturer’s risk management process and its appraisal and analysis of the performance evaluation | |||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 4.5.1 seventh indent Annex VII | Procedures to carry out the specific procedures referred to in Sections 5. of Annex IX | |||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 4.5.1 eighth indent Annex VII | In the case of class B or class C devices, procedures to assess the technical documentation of devices selected on a representative basis | Article 48 Annex VII 4.5.2 Annex IX 2.3 3.5 | ||||||||||
| MDCG 2019-13 | ||||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 4.5.1 ninth and tenth 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 | ||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 4.5.1 eleventh indent Annex VII | Procedures to evaluate and verify a manufacturer's compliance with relevant Annexes | |||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 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 | ||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 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 B and C - Selection of site auditors | Annex IX Chapter I | ||||||||||
| MDCG 2019-6 Q IV.2 | ||||||||||||
| MDCG 2019-13 | ||||||||||||
| MDCG 2022-17 | ||||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 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 Representative example of a full assessment of Technical Documentation, including the performance evaluation, for one device (preferably high-risk) | Article 48 Annex II Annex III Annex IX Chapter II | ||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 4.5.3 Type-examinations Annex VII | Procedures to examine and assess the manufacturer’s technical documentation and verify the type, including establishment of tests plans | Annex X | ||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 4.5.3 Verification by examination and testing of every product batch Annex VII | Documentation relating to verification by examination and testing of every product batch, including establishment of test plans | Annex IX Annex XI | ||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 4.5.4 Performance evaluation assessment | ||||||||||||
| 4.5.4 Annex VII | Procedures for the review of the manufacturer’s procedures and documentation relating to performance evaluation, including the validation of the summary of safety and performance (for class C and D) and the upload of the summary to EUDAMED | Article 29 Article 56 Annex II 6.1; 6.2 Annex XIII | ||||||||||
| MDCG 2022-2 | ||||||||||||
| MDCG 2022-9 | ||||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 4.5.5 Specific Procedures | ||||||||||||
| 4.5.5 Annex VII | Documentation relating to documented procedures, expertise and facilities to carry out the specific procedures: - Assessment of devices for self-testing and near-patient testing (5.1 Annex IX) - Consultation to expert panel for certain class D devices (Article 48.6, 4.9 Annex IX and 3(j) Annex X) - Consultation to medicinal products authority for companion diagnostics (5.2 Annex IX) - Batch verification for class D devices (4.12 Annex IX and 5.1 Annex XI) | Article 50 Annex IX Sections 4 and 5 Annex XI Section 5 | ||||||||||
| MDCG 2021-4 | ||||||||||||
| MDCG 2021-22 | ||||||||||||
| MDCG 2022-3 | ||||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 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) - Performance Evaluation Assessment report (PEAR) - 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 | |||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 4.7 Final review | ||||||||||||
| 4.7 Annex VII | Documentation relating to the final review process carried out prior to making a final decision | |||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 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 - List of certificates held by the NB for the different types of conformity assessments for which the NB is designated - Notification of the outcome of the assessment and the resultant decision to the manufacturer and EUDAMED | Articles 51 and 52(g) Annex XII | ||||||||||
| MDCG 2018-8 | ||||||||||||
| MDCG 2019-6 Q IV.3 Q IV.6 Q IV.8 | ||||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 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 | ||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 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 | |||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 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 PMPF - 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 4 | ||||||||||
| MDCG 2019-6 Q IV.10 | ||||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| Vigilance | Procedures to review vigilance data which the NB has access under Article 87(2) and estimating the impact on issued certificates, including the recording of the results of the evaluation and any decisions taken | |||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| PSUR | Documentation relating to the review of periodic safety update reports | Article 81 | ||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| Conditions | Procedures related to conditions for certification | |||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| 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 | ||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||
| Article 53 | Documentation relating to voluntary changes of a notified body | MDCG 2018-8 | ||||||||||
| MDCG 2019-6 Q IV.4 | ||||||||||||
| Title and Revision Document 1 | Comment | |||||||||||
| Title and Revision Document 2 | Comment | |||||||||||