3.RESOURCE REQUIREMENTS
3.1.General
3.1.1.Notified bodies shall be capable of carrying out all the tasks falling to them under this Regulation with the highest degree of professional integrity and the requisite competence in the specific field, whether those tasks are carried out by the notified body itself or on its behalf and under its responsibility.
In particular, notified bodies shall have the necessary personnel and possess or have access to all equipment, facilities and competence needed to perform properly the technical, scientific and administrative tasks entailed in the conformity assessment activities in relation to which they have been designated. Such requirement presupposes at all times and for each conformity assessment procedure and each type of devices in relation to which they have been designated, that the notified body has permanent availability of sufficient administrative, technical and scientific personnel who possess experience and knowledge relating to the relevant devices and the corresponding technologies. Such personnel shall be in sufficient numbers to ensure that the notified body in question can perform the conformity assessment tasks, including the assessment of the medical functionality, performance evaluations and the performance and safety of devices, for which it has been designated, having regard to the requirements of this Regulation, in particular those set out in Annex I.
A notified body's cumulative competences shall be such as to enable it to assess the types of devices for which it is designated. The notified body shall have sufficient internal competence to critically evaluate assessments conducted by external expertise. Tasks which a notified body is precluded from subcontracting are set out in Section 4.1.
Personnel involved in the management of the operation of a notified body's conformity assessment activities for devices shall have appropriate knowledge to set up and operate a system for the selection of assessment and verification staff, for verification of their competence, for authorisation and allocation of their tasks, for organisation of their initial and ongoing training, and for their assignment of their duties and monitoring of those staff, in order to ensure that personnel who carry out and perform assessment and verification operations are competent to fulfil the tasks required of them.
The notified body shall identify at least one individual within its top-level management as having overall responsibility for all conformity assessment activities in relation to devices.
3.1.2.The notified body shall ensure that personnel involved in conformity assessment activities maintain their qualification and expertise by implementing a system for exchange of experience and a continuous training and education programme.
3.1.3.The notified body shall clearly document the extent and limits of duties and responsibilities and the level of authorisation of to the personnel, including any subcontractors and external experts involved in conformity assessment activities and inform those personnel accordingly.
3.2.Qualification criteria in relation to personnel
3.2.1.The notified body shall establish and document qualification criteria and procedures for selection and authorisation of persons involved in conformity assessment activities, including as regards knowledge, experience and other competence required, and the required initial and ongoing training. The qualification criteria shall address the various functions within the conformity assessment process, such as auditing, product evaluation or testing, technical documentation review, decision-making, and batch release, as well as the devices, technologies and areas, such as biocompatibility, sterilisation, self and near patient-testing, companion diagnostics and performance evaluation, covered by the scope of designation.
3.2.2.The qualification criteria referred to in Section 3.2.1 shall refer to the scope of the notified body's designation in accordance with the scope description used by the Member State for the notification referred to in Article 38(3), providing a sufficient level of detail for the required qualification within the subdivisions of the scope description.
Specific qualification criteria shall be defined at least for the assessment of:
biological safety,
performance evaluation,
devices for self and near patient testing,
companion diagnostics,
functional safety,
software,
packaging, and
the different types of sterilisation processes.
3.2.3.The personnel responsible for establishing qualification criteria and for authorising other personnel to perform specific conformity assessment activities shall be employed by the notified body itself and shall not be external experts or subcontracted. They shall have proven knowledge and experience in all of the following:
Union devices legislation and relevant guidance documents;
the conformity assessment procedures provided for in this Regulation;
a broad base of knowledge of device technologies and the design and manufacture of devices;
the notified body's quality management system, related procedures and the required qualification criteria;
training relevant to personnel involved in conformity assessment activities in relation to devices;
adequate experience in conformity assessments under this Regulation or previously applicable law within a notified body.
3.2.4.The notified body shall have permanent availability of personnel with relevant clinical expertise and where possible such personnel shall be employed by the notified body itself. Such personnel shall be integrated throughout the notified body's assessment and decision-making process in order to:
identify when specialist input is required for the assessment of the performance evaluation conducted by the manufacturer and identify appropriately qualified experts;
appropriately train external clinical experts in the relevant requirements of this Regulation, CS, guidance and harmonised standards and ensure that the external clinical experts are fully aware of the context and implications of their assessment and the advice they provide;
be able to review and scientifically challenge the clinical data contained within the performance evaluation, and any associated performance study, and appropriately guide external clinical experts in the assessment of the performance evaluation presented by the manufacturer;
be able to scientifically evaluate and, if necessary, challenge the performance evaluation presented, and the results of the external clinical experts' assessment of the manufacturer's performance evaluation;
be able to ascertain the comparability and consistency of the assessments of performance evaluation conducted by clinical experts;
be able to make an assessment of the manufacturer's performance evaluation and a clinical judgement of the opinion provided by any external expert and make a recommendation to the notified body's decision maker; and
be able to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
3.2.5.The personnel responsible for carrying out product-related reviews, (product reviewers), such as technical documentation reviews or type examination, including aspects such as performance evaluation, biological safety, sterilisation and software validation, shall have all the following proven qualifications:
successful completion of a university or a technical college degree or an equivalent qualification in relevant studies, such as medicine, pharmacy, engineering or other relevant sciences;
four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing, or research, of which two years shall be in the design, manufacture, testing or use of devices or technology to be assessed or related to the scientific aspects to be assessed;
knowledge of device legislation, including the general safety and performance requirements set out in Annex I;
appropriate knowledge and experience of relevant harmonised standards, CS and guidance documents;
appropriate knowledge and experience of risk management and related device standards and guidance documents;
appropriate knowledge and experience of performance evaluation;
appropriate knowledge of the devices which they are assessing;
appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes IX to XI, in particular of the aspects of those procedures for which they are responsible, and adequate authorisation for carrying out those assessments;
the ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
3.2.6.The personnel responsible for carrying out audits of the manufacturer's quality management system (site auditors) shall have all of the following proven qualifications:
successful completion of a university or a technical college degree or equivalent qualification in relevant studies, such as medicine, pharmacy, engineering or other relevant sciences;
four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the area of quality management;
appropriate knowledge of devices legislation as well as related harmonised standards, CS and guidance documents;
appropriate knowledge and experience of risk management and related device standards and guidance documents;
appropriate knowledge of quality management systems and related l devices standards and guidance documents;
appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes IX to XI, in particular of the aspects of those procedures for which they are responsible, and adequate authorisation for carrying out those audits;
training in auditing techniques enabling them to challenge quality management systems;
the ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
3.2.7.The personnel with overall responsibility for final reviews and decision-making on certification shall be employed by the notified body itself and shall not be external experts or be subcontracted. Those personnel, as a group, shall have proven knowledge and comprehensive experience of all of the following:
devices legislation and relevant guidance documents;
device conformity assessments relevant to this Regulation;
the types of qualifications, experience and expertise relevant to device conformity assessment;
a broad base of knowledge of device technologies, including sufficient experience of the conformity assessment of devices being reviewed for certification, the device industry and the design and manufacture of devices;
the notified body's quality system, related procedures and the required qualifications for personnel involved;
the ability to draw up records and reports demonstrating that the conformity assessment activities have been appropriately carried out.
3.3.Documentation of qualification, training and authorisation of personnel
3.3.1.The notified body shall have a procedure in place to fully document the qualification of each member of personnel involved in conformity assessment activities and the satisfaction of the qualification criteria referred to in Section 3.2. Where, in exceptional circumstances, the fulfilment of the qualification criteria set out in Section 3.2 cannot be fully demonstrated, the notified body shall justify to the authority responsible for notified bodies the authorisation of those members of personnel to carry out specific conformity assessment activities.
3.3.2.For all of its personnel referred to in Sections 3.2.3 to 3.2.7, the notified body shall establish and maintain up to date:
a matrix detailing the authorisations and responsibilities of the personnel in respect of conformity assessment activities;
records attesting to the required knowledge and experience for the conformity assessment activity for which they are authorised. 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.
3.4.Subcontractors and external experts
3.4.1.Notified bodies may, without prejudice to Section 3.2, subcontract certain clearly defined component parts of a conformity assessment activity.
The subcontracting of the auditing of quality management systems or of product-related reviews as a whole shall not be permitted, nevertheless parts of those activities may be conducted by subcontractors and external auditors and experts working on behalf of the notified body. The notified body in question shall retain full responsibility for being able to produce appropriate evidence of the competence of subcontractors and experts to fulfil their specific tasks, for making a decision based on a subcontractor's assessment and for the work conducted by subcontractors and experts on its behalf.
The following activities may not be subcontracted by notified bodies:
review of the qualifications and monitoring of the performance of external experts;
auditing and certification activities where the subcontracting in question is to auditing or certification organisations;
allocation of work to external experts for specific conformity assessment activities;
final review and decision-making functions.
3.4.2.Where a notified body subcontracts certain conformity assessment activities either to an organisation or an individual, it shall have a policy describing the conditions under which subcontracting may take place, and shall ensure that:
the subcontractor meets the relevant requirements of this Annex;
subcontractors and external experts do not further subcontract work to organisations or personnel;
the natural or legal person that applied for conformity assessment has been informed of the requirements referred to in the first and second indent.
Any subcontracting or consultation of external personnel shall be properly documented, shall not involve any intermediaries, and shall be subject to a written agreement covering, among other things, confidentiality and conflicts of interest. The notified body in question shall take full responsibility for the tasks performed by subcontractors.
3.4.3.Where subcontractors or external experts are used in the context of a conformity assessment, in particular regarding novel devices or technologies, the notified body in question shall have adequate internal competence in each product area for which it is designated that is adequate for the purpose of leading the overall conformity assessment, verifying the appropriateness and validity of expert opinions and making decisions on certification.
3.5.Monitoring of competences, training and exchange of experience
3.5.1.The notified body shall establish procedures for the initial evaluation and on-going monitoring of the competence, conformity assessment activities and performance of all internal and external personnel and subcontractors, involved in conformity assessment activities.
3.5.2.Notified bodies shall review at regular intervals, the competence of their personnel, identify training needs and draw up a training plan to maintain the required level of qualification and knowledge of individual personnel. That review shall as a minimum, verify that personnel:
are aware of the Union and national law in force on devices, relevant harmonised standards, CS, guidance documents and the results of the coordination activities referred to in Section 1.6;
take part in the internal exchange of experience and the continuous training and education programme referred to in Section 3.1.2.