Textual Amendments
F1Words 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)
Designating authority: …
Name of the applying conformity assessment body: …
Previous name (if applicable): …
[F2Approved] Body number (if applicable): …
Textual Amendments
F2Word 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)
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/issue | Corresponding Annex I section | Attachment number + Reference(Section/page) | |
|---|---|---|---|
| ORGANISATIONAL AND GENERAL REQUIREMENTS | |||
| Legal status and organisational structure | |||
| 1 | Company statutes | ||
| 2 | Extract of company registration or enrolment act (Company register) | ||
| 3 | Documentation on the activities of the organisation to which the conformity assessment body belongs (if any) and its relationship with the conformity assessment body | ||
| 4 | Documentation on entities the conformity assessment body owns (if any) F3... | ||
| 5 | Description of legal ownership and the legal or natural persons exercising control of the conformity assessment body | ||
| 6 | Description of organisational structure and the operational management of the conformity assessment body | ||
| 7 | Descriptions of functions, responsibilities and authorities of top-level management | ||
| 8 | List of all staff who have an influence in the conformity assessment activities | ||
| 9 | Documentation on other services provided by the conformity assessment body (if any) (e.g. consultancy relevant to devices, training etc.) | ||
| 10 | Documentation on accreditation(s) relevant to this application | ||
| Independence and impartiality | |||
| 11 | Documentation 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 | ||
| 12 | Description of how the conformity assessment body ensures that the activities of subsidiaries, subcontractors and external experts do not affect its independence, impartiality or objectivity | ||
| 13 | Documentation on the impartiality of the top-level management and personnel involved in conformity assessment activities, including their remuneration and bonuses | ||
| 14 | Documentation on conflict of interest and resolution of potential conflict procedure/form | ||
| 15 | Description of independence of the conformity assessment body from [F4the Secretary of State] | ||
| Confidentiality | |||
| 16 | Documentation on professional secrecy procedure including protection of proprietary data | ||
| Liability | |||
| 17 | Documentation of the liability insurance, proof that the liability insurance covers cases where the [F5approved body] may be obliged to withdraw or suspend certificates | ||
| Financial resources | |||
| 18 | Documentation 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 [F5approved body] and consistency with the range of products certified | ||
| Quality system | |||
| 19 | Quality 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 | ||
| 20 | Documentation on the procedure(s) for control of documents | ||
| 21 | Documentation on the procedure(s) for control of records | ||
| 22 | Documentation on the procedure(s) for management review | ||
| 23 | Documentation on the procedure(s) for internal audits | ||
| 24 | Documentation on the procedure(s) for corrective and preventive actions | ||
| 25 | Documentation on the procedure(s) for complaints and appeals | ||
| Resource requirements | |||
| General | |||
| 26 | Description of own laboratories and testing facilities | ||
| 27 | Employment contracts and other agreements with internal personnel, in particular in relation to impartiality, independence, conflict of interest (attach a standard contract template) | ||
| 28 | Contracts 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 | |||
| 29 | List of all permanent and temporary personnel (technical, administrative etc.) including information on professional qualification, past experience and the types of contracts held | ||
| 30 | List of all external personnel (e.g. external experts, external auditors) including information on professional qualification, past experience and on the types of contracts held | ||
| 31 | Qualification 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 [F6approved] or wishes to be [F6approved] | ||
| 32 | Qualification criteria for the different functions (see point 31) | ||
| 33 | Documentation 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:
| ||
| 35 | Documentation on the procedure assuring ongoing monitoring of competences and performance monitoring | ||
| 36 | Documentation on standard training programmes conducted by the conformity assessment body relevant to the conformity assessment activities | ||
| Subcontractors | |||
| 37 | List of all subcontractors (not individual external experts) used for conformity assessment activities | ||
| 38 | Subcontractor policy and procedure | ||
| 39 | Documentation demonstrating adequate core competence within the conformity assessment body to assess, select, contract, and to verify the appropriateness and validity of subcontractor activities | ||
| 40 | Examples 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:
| ||
| 42 | Checklists, templates, reports and certificates used for the conformity assessment activities | ||
Textual Amendments
F3Words 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)
F4Words 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)
F5Words 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)
F6Word 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)
F7Words 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)
| Name and signature of an authorised representative of the applicant conformity assessment body (unless electronic signature is accepted) | Place and date |