Chwilio Deddfwriaeth

Commission Implementing Regulation (EU) No 920/2013Dangos y teitl llawn

Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (Text with EEA relevance)

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Changes over time for: ANNEX II

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Version Superseded: 11/08/2021

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Point in time view as at 31/12/2020.

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Commission Implementing Regulation (EU) No 920/2013, ANNEX II is up to date with all changes known to be in force on or before 31 October 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations. Help about Changes to Legislation

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ANNEX IIU.K. Application form to be submitted when applying for designation as notified body

Designating authority: …

Name of the applying conformity assessment body: …

Previous name (if applicable): …

EU Notified Body number (if applicable): …

Address: …

Contact person: …

E-mail: …

Telephone: …

Legal form of the conformity assessment body: …

Company registration number: …

At company register: …

The following documents shall be added. In case of extension or renewal, only new or modified documents shall be submitted.

Item/issueCorresponding Annex I sectionAttachment number + Reference(Section/page)
ORGANISATIONAL AND GENERAL REQUIREMENTS
Legal status and organisational structure
1Company statutes
2Extract of company registration or enrolment act (Company register)
3Documentation on the activities of the organisation to which the conformity assessment body belongs (if any) and its relationship with the conformity assessment body
4Documentation on entities the conformity assessment body owns (if any), either within the Member State or outside, and the relationship with those entities
5Description of legal ownership and the legal or natural persons exercising control of the conformity assessment body
6Description of organisational structure and the operational management of the conformity assessment body
7Descriptions of functions, responsibilities and authorities of top-level management
8List of all staff who have an influence in the conformity assessment activities
9Documentation on other services provided by the conformity assessment body (if any) (e.g. consultancy relevant to devices, training etc.)
10Documentation on accreditation(s) relevant to this application
Independence and impartiality
11Documentation on structures, policies and procedures to safeguard and promote the principles of impartiality throughout the organisation, personnel and assessment activities, including ethical rules or codes of conduct
12Description of how the conformity assessment body ensures that the activities of subsidiaries, subcontractors and external experts do not affect its independence, impartiality or objectivity
13Documentation on the impartiality of the top-level management and personnel involved in conformity assessment activities, including their remuneration and bonuses
14Documentation on conflict of interest and resolution of potential conflict procedure/form
15Description of independence of the conformity assessment body from the designating authority and from the competent authority, in particular when this body is a public entity/institution
Confidentiality
16Documentation on professional secrecy procedure including protection of proprietary data
Liability
17Documentation of the liability insurance, proof that the liability insurance covers cases where the notified body may be obliged to withdraw or suspend certificates
Financial resources
18Documentation of the financial resources required to conduct the conformity assessment activities, related operations, including the ongoing commitments for certificates issued to demonstrate the continuing viability of the notified body and consistency with the range of products certified
Quality system
19Quality Manual and a list of related documentation on the implementation, maintenance and operation of a quality management system, including policies for assignment of personnel to activities and their responsibilities
20Documentation on the procedure(s) for control of documents
21Documentation on the procedure(s) for control of records
22Documentation on the procedure(s) for management review
23Documentation on the procedure(s) for internal audits
24Documentation on the procedure(s) for corrective and preventive actions
25Documentation on the procedure(s) for complaints and appeals
Resource requirements
General
26Description of own laboratories and testing facilities
27Employment contracts and other agreements with internal personnel, in particular in relation to impartiality, independence, conflict of interest (attach a standard contract template)
28Contracts and other agreements with subcontractors and external experts, in particular for impartiality, independence, conflict of interest (attach a standard contract template)
Qualification and authorisation of personnel
29List of all permanent and temporary personnel (technical, administrative etc.) including information on professional qualification, past experience and the types of contracts held
30List of all external personnel (e.g. external experts, external auditors) including information on professional qualification, past experience and on the types of contracts held
31Qualification matrix linking the body's staff and its external experts to the functions to be accomplished by them and to the fields of competence for which the body has been notified or wishes to be notified
32Qualification criteria for the different functions (see point 31)
33Documentation on the procedure(s) for selection and assignment of internal or external personnel involved in the conformity assessment activities, including conditions for the attribution of tasks to external personnel and the supervision of their expertise
34

Documentation demonstrating that the management of the conformity assessment body has appropriate knowledge to set up and operate a system for:

  • the selection of the personnel deployed during the conformity assessment,

  • the verification of the knowledge and experience of this personnel,

  • the assignment of the personnel to their tasks,

  • the verification of the performance of the personnel,

  • the definition and the verification of their initial and ongoing training

35Documentation on the procedure assuring ongoing monitoring of competences and performance monitoring
36Documentation on standard training programmes conducted by the conformity assessment body relevant to the conformity assessment activities
Subcontractors
37List of all subcontractors (not individual external experts) used for conformity assessment activities
38Subcontractor policy and procedure
39Documentation demonstrating adequate core competence within the conformity assessment body to assess, select, contract, and to verify the appropriateness and validity of subcontractor activities
40Examples of standard template contract, prohibiting further subcontracting by legal persons and specifically including provisions to ensure confidentiality and conflict of interest management with subcontractors (attach examples)
Process
41

Documentation on procedures relating to conformity assessment activities and other related documents reflecting the scope of conformity assessment activities including, in particular procedures relating to:

  • Qualification and classification

  • Quality system assessments

  • Risk management

  • Pre-clinical data evaluation

  • Clinical evaluation

  • Representative sampling of technical documentation

  • Post-market clinical follow up

  • Communications from regulatory authorities including competent authorities and designating authorities

  • Communication and analysis of the impact of vigilance reports on device certification

  • Consultation procedures for drug-device combination products, devices utilising animal tissue, devices utilising human blood derivatives

  • Review and decision making on certificate issuance including approval responsibilities

  • Review and decision making on certificate suspension, restriction, withdrawal and refusal including approval responsibilities

42Checklists, templates, reports and certificates used for the conformity assessment activities
Name and signature of an authorised representative of the applicant conformity assessment body (unless electronic signature is accepted)Place and date

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