{
  "url": "https://openlegislation.uk/eu-regulation-2013-920/annex-II",
  "json_url": "https://openlegislation.uk/eu-regulation-2013-920/annex-II.json",
  "legislation": "eur/2013/920",
  "legislation_title": "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)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2013-920",
  "path": "annex/II",
  "kind": "annex",
  "number": "II",
  "heading": "Application form to be submitted when applying for designation as an approved body",
  "text": "Designating authority: …\nName of the applying conformity assessment body: …\nPrevious name (if applicable): …\nApproved Body number (if applicable): …\nAddress: …\n…\n…\n…\nContact person: …\nE-mail: …\nTelephone: …\nLegal form of the conformity assessment body: …\nCompany registration number: …\nAt company register: …\n…\n…\nThe following documents shall be added. In case of extension or renewal, only new or modified documents shall be submitted.\nItem/issue\nCorresponding Annex I section\nAttachment number + Reference(Section/page)\nORGANISATIONAL AND GENERAL REQUIREMENTS\nLegal status and organisational structure\n1\nCompany statutes\n2\nExtract of company registration or enrolment act (Company register)\n3\nDocumentation on the activities of the organisation to which the conformity assessment body belongs (if any) and its relationship with the conformity assessment body\n4\nDocumentation on entities the conformity assessment body owns (if any) ...\n5\nDescription of legal ownership and the legal or natural persons exercising control of the conformity assessment body\n6\nDescription of organisational structure and the operational management of the conformity assessment body\n7\nDescriptions of functions, responsibilities and authorities of top-level management\n8\nList of all staff who have an influence in the conformity assessment activities\n9\nDocumentation on other services provided by the conformity assessment body (if any) (e.g. consultancy relevant to devices, training etc.)\n10\nDocumentation on accreditation(s) relevant to this application\nIndependence and impartiality\n11\nDocumentation 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\n12\nDescription of how the conformity assessment body ensures that the activities of subsidiaries, subcontractors and external experts do not affect its independence, impartiality or objectivity\n13\nDocumentation on the impartiality of the top-level management and personnel involved in conformity assessment activities, including their remuneration and bonuses\n14\nDocumentation on conflict of interest and resolution of potential conflict procedure/form\n15\nDescription of independence of the conformity assessment body from the Secretary of State\nConfidentiality\n16\nDocumentation on professional secrecy procedure including protection of proprietary data\nLiability\n17\nDocumentation of the liability insurance, proof that the liability insurance covers cases where the approved body may be obliged to withdraw or suspend certificates\nFinancial resources\n18\nDocumentation 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 approved body and consistency with the range of products certified\nQuality system\n19\nQuality 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\n20\nDocumentation on the procedure(s) for control of documents\n21\nDocumentation on the procedure(s) for control of records\n22\nDocumentation on the procedure(s) for management review\n23\nDocumentation on the procedure(s) for internal audits\n24\nDocumentation on the procedure(s) for corrective and preventive actions\n25\nDocumentation on the procedure(s) for complaints and appeals\nResource requirements\nGeneral\n26\nDescription of own laboratories and testing facilities\n27\nEmployment contracts and other agreements with internal personnel, in particular in relation to impartiality, independence, conflict of interest (attach a standard contract template)\n28\nContracts and other agreements with subcontractors and external experts, in particular for impartiality, independence, conflict of interest (attach a standard contract template)\nQualification and authorisation of personnel\n29\nList of all permanent and temporary personnel (technical, administrative etc.) including information on professional qualification, past experience and the types of contracts held\n30\nList of all external personnel (e.g. external experts, external auditors) including information on professional qualification, past experience and on the types of contracts held\n31\nQualification 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 approved or wishes to be approved\n32\nQualification criteria for the different functions (see point 31)\n33\nDocumentation 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\n34\nDocumentation demonstrating that the management of the conformity assessment body has appropriate knowledge to set up and operate a system for:\nthe selection of the personnel deployed during the conformity assessment,\nthe verification of the knowledge and experience of this personnel,\nthe assignment of the personnel to their tasks,\nthe verification of the performance of the personnel,\nthe definition and the verification of their initial and ongoing training\n35\nDocumentation on the procedure assuring ongoing monitoring of competences and performance monitoring\n36\nDocumentation on standard training programmes conducted by the conformity assessment body relevant to the conformity assessment activities\nSubcontractors\n37\nList of all subcontractors (not individual external experts) used for conformity assessment activities\n38\nSubcontractor policy and procedure\n39\nDocumentation demonstrating adequate core competence within the conformity assessment body to assess, select, contract, and to verify the appropriateness and validity of subcontractor activities\n40\nExamples 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)\nProcess\n41\nDocumentation on procedures relating to conformity assessment activities and other related documents reflecting the scope of conformity assessment activities including, in particular procedures relating to:\nQualification and classification\nQuality system assessments\nRisk management\nPre-clinical data evaluation\nClinical evaluation\nRepresentative sampling of technical documentation\nPost-market clinical follow up\nCommunications from the Secretary of State or other regulatory authorities\nCommunication and analysis of the impact of vigilance reports on device certification\nConsultation procedures for drug-device combination products, devices utilising animal tissue, devices utilising human blood derivatives\nReview and decision making on certificate issuance including approval responsibilities\nReview and decision making on certificate suspension, restriction, withdrawal and refusal including approval responsibilities\n42\nChecklists, templates, reports and certificates used for the conformity assessment activities\nName and signature of an authorised representative of the applicant conformity assessment body (unless electronic signature is accepted)\nPlace and date",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Annex 2 heading substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 32(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Word in Annex 2 substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 32(b)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in Annex 2 omitted (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 32(c)(i)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in Annex 2 substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 32(c)(ii)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Words in Annex 2 substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 32(c)(iii)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Word in Annex 2 substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 32(c)(iv)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Words in Annex 2 substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 32(c)(v)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2013/920/annex/II",
    "retrieved_at": "2026-11-01T14:48:24.338131+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}